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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02528188
Registration number
NCT02528188
Ethics application status
Date submitted
19/07/2015
Date registered
19/08/2015
Date last updated
10/01/2020
Titles & IDs
Public title
Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
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Scientific title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
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Secondary ID [1]
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2012-003721-22
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Secondary ID [2]
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A4091058
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Pain
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Osteoarthritis, Hip
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Osteoarthritis, Knee
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - NSAID
Other interventions - Tanezumab 2.5 mg
Other interventions - Tanezumab 5 mg
Active Comparator: NSAID - Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
Experimental: Tanezumab 2.5 mg - Subcutaneous injection of tanezumab 2.5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac ER) twice daily for 56 weeks
Experimental: Tanezumab 5 mg - Subcutaneous injection of tanezumab 5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac) twice daily for 56 weeks
Treatment: Drugs: NSAID
Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
Other interventions: Tanezumab 2.5 mg
Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks
Other interventions: Tanezumab 5 mg
Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome
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Assessment method [1]
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Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to [>=] 2 millimeters [mm]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
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Timepoint [1]
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Baseline up to Week 80
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Primary outcome [2]
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Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome
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Assessment method [2]
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Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
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Timepoint [2]
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Baseline up to Week 80
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Primary outcome [3]
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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
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Assessment method [3]
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WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
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Timepoint [3]
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Baseline, Week 16
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Primary outcome [4]
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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
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Assessment method [4]
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WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
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Timepoint [4]
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Baseline, Week 16
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Primary outcome [5]
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Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16
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Assessment method [5]
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PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using Interactive Response Technology (IRT), where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
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Timepoint [5]
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Baseline, Week 16
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Secondary outcome [1]
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Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome
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Assessment method [1]
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Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
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Timepoint [1]
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Baseline up to Week 80
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Secondary outcome [2]
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Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome
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Assessment method [2]
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Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Secondary joint safety outcome included primary osteonecrosis, rapidly progressive OA (type-2), subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
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Timepoint [2]
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Baseline up to Week 80
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Secondary outcome [3]
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Percentage of Participants With Individual Adjudicated Joint Safety Outcome
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Assessment method [3]
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Any participant with incidence of an adjudicated outcome of rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of JSW >=2 mm within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
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Timepoint [3]
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Baseline up to Week 80
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Secondary outcome [4]
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Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome
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Assessment method [4]
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Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Individual joint safety outcome included rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
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Timepoint [4]
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Baseline up to Week 80
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Secondary outcome [5]
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Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome
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Assessment method [5]
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Percentage of participants with total joint replacement (hip, knee or shoulder) or adjudicated primary composite joint safety outcomes were reported. Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture.
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Timepoint [5]
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Baseline up to Week 80
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Secondary outcome [6]
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Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome
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Assessment method [6]
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Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
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Timepoint [6]
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Baseline up to Week 80
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Secondary outcome [7]
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Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80
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Assessment method [7]
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Change from baseline in JSW was defined as change in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the medial and lateral tibiofemoral of knee in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral).
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Timepoint [7]
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Baseline, Weeks 56 and 80
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Secondary outcome [8]
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Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80
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Assessment method [8]
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Change from baseline in JSW was defined as narrowing in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the index hip in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.
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Timepoint [8]
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Baseline, Weeks 56 and 80
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Secondary outcome [9]
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Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80
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Assessment method [9]
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Progression of OA according to Bland-Altman as defined by a decrease JSW >=1.96 times within-participant standard deviation of change in JSW. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function.
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Timepoint [9]
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Weeks 56 and 80
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Secondary outcome [10]
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Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80
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Assessment method [10]
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Progression of OA according to Bland-Altman methodology as defined by a decrease in JSW >=1.96 times within-participant standard deviation of the change in JSW in the index hip. The number of participants with progression of OA in the index hip per Bland-Altman methodology are reported. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.
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Timepoint [10]
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Weeks 56 and 80
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Secondary outcome [11]
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Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
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Assessment method [11]
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WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
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Timepoint [11]
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Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
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Secondary outcome [12]
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Change From Baseline in WOMAC Pain Subscale at Week 64
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Assessment method [12]
0
0
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
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Timepoint [12]
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Baseline, Week 64
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Secondary outcome [13]
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Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
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Assessment method [13]
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0
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
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Timepoint [13]
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Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
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Secondary outcome [14]
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Change From Baseline in WOMAC Physical Function Subscale at Week 64
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Assessment method [14]
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0
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
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Timepoint [14]
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Baseline, Week 64
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Secondary outcome [15]
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Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
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Assessment method [15]
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PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
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Timepoint [15]
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Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
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Secondary outcome [16]
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Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64
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Assessment method [16]
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PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
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Timepoint [16]
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Baseline, Week 64
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Secondary outcome [17]
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Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
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Assessment method [17]
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Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was >=50 percent and >= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of OA. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and PGA of OA (score: 1 [very good] to 5 [very poor], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).
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Timepoint [17]
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Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
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Secondary outcome [18]
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Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
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Assessment method [18]
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Percentage of participants with reduction in WOMAC pain intensity of >= 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.
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Timepoint [18]
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Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
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Secondary outcome [19]
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Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56
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Assessment method [19]
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0
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than [>] 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.
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Timepoint [19]
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Baseline, Weeks 16, 24 and 56
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Secondary outcome [20]
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Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
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Assessment method [20]
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Percentage of participants with reduction in WOMAC physical function of >=(30%,50%,70%,90%) at Weeks 2,4,8,16,24,32,40,48,56 and 64 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
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Timepoint [20]
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0
Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
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Secondary outcome [21]
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Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56
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Assessment method [21]
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Percentage of participants with cumulative reduction (as percent) (> 0 %; >= 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%; =100%) in WOMAC physical function subscale from baseline to Weeks 16, 24 and 56 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
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Timepoint [21]
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Baseline, Weeks 16, 24 and 56
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Secondary outcome [22]
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Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
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Assessment method [22]
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PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF.
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Timepoint [22]
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Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
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Secondary outcome [23]
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Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56
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Assessment method [23]
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Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data for Weeks 20 through 56 represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
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Timepoint [23]
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0
Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56
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Secondary outcome [24]
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0
Change From Baseline in Average Pain Score in the Index Joint at Week 64
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Assessment method [24]
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Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including Week 64. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Query!
Timepoint [24]
0
0
Baseline, Week 64
Query!
Secondary outcome [25]
0
0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Assessment method [25]
0
0
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Query!
Timepoint [25]
0
0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Secondary outcome [26]
0
0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64
Query!
Assessment method [26]
0
0
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Query!
Timepoint [26]
0
0
Baseline, Week 64
Query!
Secondary outcome [27]
0
0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Assessment method [27]
0
0
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Query!
Timepoint [27]
0
0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Secondary outcome [28]
0
0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64
Query!
Assessment method [28]
0
0
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Query!
Timepoint [28]
0
0
Baseline, Week 64
Query!
Secondary outcome [29]
0
0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Assessment method [29]
0
0
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Query!
Timepoint [29]
0
0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Secondary outcome [30]
0
0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64
Query!
Assessment method [30]
0
0
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Query!
Timepoint [30]
0
0
Baseline, Week 64
Query!
Secondary outcome [31]
0
0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Assessment method [31]
0
0
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Query!
Timepoint [31]
0
0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Secondary outcome [32]
0
0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64
Query!
Assessment method [32]
0
0
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Query!
Timepoint [32]
0
0
Baseline, Week 64
Query!
Secondary outcome [33]
0
0
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56
Query!
Assessment method [33]
0
0
WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Query!
Timepoint [33]
0
0
Weeks 16, 24 and 56
Query!
Secondary outcome [34]
0
0
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64
Query!
Assessment method [34]
0
0
WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Query!
Timepoint [34]
0
0
Baseline, Week 64
Query!
Secondary outcome [35]
0
0
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain
Query!
Assessment method [35]
0
0
Number of participants with mobility domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Query!
Timepoint [35]
0
0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Query!
Secondary outcome [36]
0
0
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain
Query!
Assessment method [36]
0
0
Number of participants with self-care domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Query!
Timepoint [36]
0
0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Query!
Secondary outcome [37]
0
0
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain
Query!
Assessment method [37]
0
0
Number of participants with usual activities domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Query!
Timepoint [37]
0
0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Query!
Secondary outcome [38]
0
0
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain
Query!
Assessment method [38]
0
0
Number of participants with pain/discomfort domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Query!
Timepoint [38]
0
0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Query!
Secondary outcome [39]
0
0
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain
Query!
Assessment method [39]
0
0
Number of participants with anxiety/ depression domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Query!
Timepoint [39]
0
0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Query!
Secondary outcome [40]
0
0
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value
Query!
Assessment method [40]
0
0
EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than or equal to (<=) 1. The Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.
Query!
Timepoint [40]
0
0
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Query!
Secondary outcome [41]
0
0
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses
Query!
Assessment method [41]
0
0
TSQM v.II is a self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (scored on a 7-point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied]) and dissatisfaction with side effects (3 questions scored on 5 point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied] and 1 question on 2 point scale [0 =No, 1=Yes]). Participants were asked to assess their level of satisfaction taking all things into account. The 11 questions of the TSQM were used to calculate the 4 endpoints of effectiveness, side Effects, convenience and global satisfaction, each scored on a 0-100 scale with 100 being the best level of satisfaction.
Query!
Timepoint [41]
0
0
Weeks 16 and 56
Query!
Secondary outcome [42]
0
0
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling?
Query!
Assessment method [42]
0
0
The mPRTI is a self-administered questionnaire containing participant's global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant's willingness to use drug again assessment. To assess current or most recent treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. Number of participants who responded for the specified question were reported.
Query!
Timepoint [42]
0
0
Weeks 16 and 56
Query!
Secondary outcome [43]
0
0
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment?
Query!
Assessment method [43]
0
0
The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess preference to continue using the investigational product, participants responded using IRT on a 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use the investigational product. Number of participants who responded for the specified question were reported.
Query!
Timepoint [43]
0
0
Weeks 16 and 56
Query!
Secondary outcome [44]
0
0
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain?
Query!
Assessment method [44]
0
0
The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess participant willingness to use drug again, participants responded using IRT on a 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. Number of participants who responded for the specified question were reported.
Query!
Timepoint [44]
0
0
Weeks 16 and 56
Query!
Secondary outcome [45]
0
0
Number of Participants Who Withdrew Due to Lack of Efficacy
Query!
Assessment method [45]
0
0
Number of participants who withdrew from treatment due to lack of efficacy have been reported here.
Query!
Timepoint [45]
0
0
Baseline up to Week 56
Query!
Secondary outcome [46]
0
0
Time to Discontinuation Due to Lack of Efficacy
Query!
Assessment method [46]
0
0
Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.
Query!
Timepoint [46]
0
0
Baseline up to Week 56
Query!
Secondary outcome [47]
0
0
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Assessment method [47]
0
0
In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.
Query!
Timepoint [47]
0
0
Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Secondary outcome [48]
0
0
Number of Participants Who Took Rescue Medication During Week 64
Query!
Assessment method [48]
0
0
In case of inadequate pain relief, after Week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during Week 64 were summarized.
Query!
Timepoint [48]
0
0
Week 64
Query!
Secondary outcome [49]
0
0
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Assessment method [49]
0
0
In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.
Query!
Timepoint [49]
0
0
Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Query!
Secondary outcome [50]
0
0
Number of Days of Rescue Medication Used During Week 64
Query!
Assessment method [50]
0
0
In case of inadequate pain relief, after week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days the participants used the rescue medication during Week 64 were summarized.
Query!
Timepoint [50]
0
0
Week 64
Query!
Secondary outcome [51]
0
0
Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16
Query!
Assessment method [51]
0
0
In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.
Query!
Timepoint [51]
0
0
Weeks 2, 4, 8 and 16
Query!
Secondary outcome [52]
0
0
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Query!
Assessment method [52]
0
0
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Visits of services directly related to OA evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.
Query!
Timepoint [52]
0
0
Baseline, Weeks 64 and 80
Query!
Secondary outcome [53]
0
0
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis
Query!
Assessment method [53]
0
0
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who visited the emergency room due to OA.
Query!
Timepoint [53]
0
0
Baseline, Weeks 64 and 80
Query!
Secondary outcome [54]
0
0
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis
Query!
Assessment method [54]
0
0
Osteoarthritis HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of visits to the emergency room due to OA.
Query!
Timepoint [54]
0
0
Baseline, Weeks 64 and 80
Query!
Secondary outcome [55]
0
0
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis
Query!
Assessment method [55]
0
0
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who were hospitalized due to OA.
Query!
Timepoint [55]
0
0
Baseline, Weeks 64 and 80
Query!
Secondary outcome [56]
0
0
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis
Query!
Assessment method [56]
0
0
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of nights stayed in the hospital due to OA.
Query!
Timepoint [56]
0
0
Baseline, Weeks 64 and 80
Query!
Secondary outcome [57]
0
0
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis
Query!
Assessment method [57]
0
0
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.
Query!
Timepoint [57]
0
0
Baseline, Weeks 64 and 80
Query!
Secondary outcome [58]
0
0
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis
Query!
Assessment method [58]
0
0
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who quit job due to OA.
Query!
Timepoint [58]
0
0
Baseline, Weeks 64 and 80
Query!
Secondary outcome [59]
0
0
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis
Query!
Assessment method [59]
0
0
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was duration since quitting job due to OA.
Query!
Timepoint [59]
0
0
Baseline, Weeks 64 and 80
Query!
Secondary outcome [60]
0
0
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80
Query!
Assessment method [60]
0
0
The LEAS is a self-administered scale to assess activity level in participants having total knee arthroplasty. The LEAS scale reflected four levels of lower-extremity activity (1)housebound(unable to walk or a minimal ability to walk) (2)more ordinary walking about the house (3)walking about the community (4)walking about the community as well as substantial work or exercise. It consisted of 12 questions resulting in 18-level scale that allowed participants to select a single description that most represented his or her self-perceived activity level. The final score was simply the number of the descriptor selected by the participant as being most representative of his or her activity level. The minimum possible score was 1(entirely bedbound) and the maximum possible score was 18(currently competitive athlete). Higher score indicated increased activity. Categorical changes from baseline were reported in terms of improvement (Change >0), No change and worsening (Change less than [<] 0).
Query!
Timepoint [60]
0
0
Baseline, Weeks 4, 8, 16, 24, 56 and 80
Query!
Secondary outcome [61]
0
0
Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56
Query!
Assessment method [61]
0
0
Participant activity level was assessed using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Query!
Timepoint [61]
0
0
Baseline, Weeks 16 and 56
Query!
Secondary outcome [62]
0
0
Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56
Query!
Assessment method [62]
0
0
An average daily physical activity count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Query!
Timepoint [62]
0
0
Baseline, Weeks 16 and 56
Query!
Secondary outcome [63]
0
0
Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56
Query!
Assessment method [63]
0
0
An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - less than {<1500} counts moderate (1,500 - <6500 counts), and vigorous (>=6500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Query!
Timepoint [63]
0
0
Baseline, Weeks 16 and 56
Query!
Secondary outcome [64]
0
0
Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56
Query!
Assessment method [64]
0
0
An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - <1,500 counts) moderate (1,500 - <6,500 counts), and vigorous (>=6,500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).A "bout" of moderate to vigorous activity was defined as 10 or more consecutive minutes above the moderate physical activity level threshold, with allowance for interruptions of 1 or 2 minutes below the threshold.
Query!
Timepoint [64]
0
0
Baseline, Weeks 16 and 56
Query!
Secondary outcome [65]
0
0
Change From Baseline in Average Daily Step Count at Weeks 16 and 56
Query!
Assessment method [65]
0
0
Average daily step count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Query!
Timepoint [65]
0
0
Baseline, Weeks 16 and 56
Query!
Secondary outcome [66]
0
0
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Query!
Assessment method [66]
0
0
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs.
Query!
Timepoint [66]
0
0
Baseline up to Week 80
Query!
Secondary outcome [67]
0
0
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Query!
Assessment method [67]
0
0
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Query!
Timepoint [67]
0
0
Baseline up to Week 80
Query!
Secondary outcome [68]
0
0
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
Query!
Assessment method [68]
0
0
Primary Abnormality criteria: HGB, hematocrit, RBC count <0.8* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width <0.9*LLN, >1.1*upper limit of normal(ULN); platelets <0.5*LLN,>1.75*ULN; Leukocytes <0.6*LLN, >1.5*ULN; Lymphocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils,Eosinophils,Monocytes>1.2*ULN; Prothrombin time/Intl. normalized ratio>1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides >1.3*ULN; Urate>1.2*ULN; sodium<0.95*LLN,>1.05*ULN; potassium,chloride,calcium,magnesium,bicarbonate <0.9*LLN, >1.1*ULN; phosphate<0.8*LLN, >1.2*ULN; glucose<0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase>2.0*ULN, specific gravity<1.003, >1.030; pH<4.5, >8;Urine erythrocytes,Leukocytes>=20.
Query!
Timepoint [68]
0
0
Baseline up to Week 80
Query!
Secondary outcome [69]
0
0
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline
Query!
Assessment method [69]
0
0
Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes, Lymphocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN; specific gravity<1.003, >1.030; Urine erythrocytes,Leukocytes>=20; Hyaline Casts>=1.
Query!
Timepoint [69]
0
0
Baseline up to Week 80
Query!
Secondary outcome [70]
0
0
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Query!
Assessment method [70]
0
0
Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Query!
Timepoint [70]
0
0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Query!
Secondary outcome [71]
0
0
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Query!
Assessment method [71]
0
0
Heart rate (pulse rate) was measured at sitting position.
Query!
Timepoint [71]
0
0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Query!
Secondary outcome [72]
0
0
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80
Query!
Assessment method [72]
0
0
A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, RR intervals) were collected. ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms.
Query!
Timepoint [72]
0
0
Baseline, Weeks 56 and 80
Query!
Secondary outcome [73]
0
0
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80
Query!
Assessment method [73]
0
0
Heart rate was measured at sitting position.
Query!
Timepoint [73]
0
0
Baseline, Weeks 56 and 80
Query!
Secondary outcome [74]
0
0
Number of Participants With Confirmed Orthostatic Hypotension
Query!
Assessment method [74]
0
0
Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
Query!
Timepoint [74]
0
0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Query!
Secondary outcome [75]
0
0
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Query!
Assessment method [75]
0
0
The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.
Query!
Timepoint [75]
0
0
Baseline, Weeks 24, 56 and 80
Query!
Secondary outcome [76]
0
0
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Query!
Assessment method [76]
0
0
NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.
Query!
Timepoint [76]
0
0
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Query!
Secondary outcome [77]
0
0
Number of Participants With Anti-Tanezumab Antibodies
Query!
Assessment method [77]
0
0
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).
Query!
Timepoint [77]
0
0
Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80
Query!
Eligibility
Key inclusion criteria
- A diagnosis of osteoarthritis of the index hip or knee based on American College of
Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the
Central Reader
- Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib,
diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or
ketoprofen) as described in the protocol along with a history of insufficient pain
relief from, inability to tolerate or contraindication to taking acetaminophen and,
tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol
specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening
period
- WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening
- Be willing to discontinue all non study pain medications for osteoarthritis and not
use prohibited pain medications throughout the duration of the study
- Female subjects of childbearing potential must agree to comply with protocol specified
contraceptive requirements
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Subjects exceeding protocol defined BMI or body weight limits
- History of other diseases specified in the protocol (eg, inflammatory joint diseases,
crystalline diseases such as gout or pseudogout) that may involve the index joint and
that could interfere with efficacy assessments
- Radiographic evidence of protocol specified bone or joint conditions in any screening
radiograph as determined by the central radiology reviewer
- A history of osteonecrosis or osteoporotic fracture
- History of significant trauma or surgery to a knee, hip or shoulder within the
previous year
- Planned surgical procedure during the duration of the study
- Presence of conditions (eg, fibromyaliga, radiculopathy) associated with moderate to
severe pain that may confound assessments or self evaluation of osteoarthritis pain
- Signs or symptoms of carpal tunnel syndrome in the year prior to Screening
- Considered unfit for surgery based upon American Society of Anesthesiologists physical
classification system for surgery grading, or subjects who would not be willing to
undergo joint replacement surgery if required
- Contraindications to magnetic resonance imaging
- History of intolerance or hypersensitivity to the oral NSAID (naproxen, celecoxib or
diclofenac) the subject could be randomized to receive or any of its excipients or
existence of a medical condition or use of concomitant medication for which the use of
this NSAID is contraindicated
- History of intolerance or hypersensitivity to acetaminophen or any of its excipients
or existence of a medical condition or use of concomitant medication for which the use
of acetaminophen is contraindicated
- Use of prohibited medications without the appropriate washout period prior to
Screening or Initial Pain Assessment Period
- History of cancer within 5 years of Screening, except for cutaneous basal cell or
squamous cell cancer resolved by excision
- Subjects with signs and symptoms of clinically significant cardiac disease as
described in the protocol
- Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis
of stroke with residual deficits that would preclude completion of required study
activities
- History, diagnosis, or signs and symptoms of clinically significant neurological
disease such as but not limited to peripheral or autonomic neuropathy
- History, diagnosis, signs or symptoms of any clinically significant psychiatric
disorder
- History of known alcohol, analgesic or drug abuse within 2 years of Screening
- Previous exposure to exogenous NGF or to an anti-NGF antibody
- History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal
antibody or IgG fusion protein
- Poorly controlled hypertension as defined in the protocol or taking an
antihypertensive that has not been stable for at least 1 month prior to Screening
- Evidence of protocol defined orthostatic hypotension at Screening
- Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening
- Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined
limits
- Presence of drugs of abuse in screening urine toxicology panel
- Positive hepatitis B, hepatitis C or HIV test results indicative of current infection
- Participation in other investigational drug studies within protocol defined time
limits
- Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling
or unable to follow protocol required contraceptive requirements
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that in the judgment of the investigator, would make the subject
inappropriate for entry into this study
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/07/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
27/02/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
3021
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Genesis Research Services - Broadmeadow
Query!
Recruitment hospital [2]
0
0
Hunter Imaging Group - Cardiff
Query!
Recruitment hospital [3]
0
0
Optimus Clinical Research Pty Ltd - Kogarah
Query!
Recruitment hospital [4]
0
0
Southern Radiology - Miranda
Query!
Recruitment hospital [5]
0
0
Royal Hospital for Women - Randwick
Query!
Recruitment hospital [6]
0
0
Castlereagh Imaging - St Leonards
Query!
Recruitment hospital [7]
0
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment hospital [8]
0
0
Australian Clinical Research Network - Sydney
Query!
Recruitment hospital [9]
0
0
Spectrum Medical Imaging - Sydney
Query!
Recruitment hospital [10]
0
0
AusTrials Pty Ltd - Sherwood
Query!
Recruitment hospital [11]
0
0
CMAX Clinical Research Pty Ltd - Adelaide
Query!
Recruitment hospital [12]
0
0
Royal Adelaide Hospital Pharmacy - Adelaide
Query!
Recruitment hospital [13]
0
0
Bensons Radiology - North Adelaide
Query!
Recruitment hospital [14]
0
0
Emeritus Research - Camberwell
Query!
Recruitment hospital [15]
0
0
Capital Radiology-Malvern - Melbourne
Query!
Recruitment hospital [16]
0
0
Capital Radiology-Clayton - Melbourne
Query!
Recruitment hospital [17]
0
0
SKG Radiology Hollywood - Nedlands
Query!
Recruitment hospital [18]
0
0
RK Will Pty Ltd - Victoria Park
Query!
Recruitment postcode(s) [1]
0
0
2292 - Broadmeadow
Query!
Recruitment postcode(s) [2]
0
0
2285 - Cardiff
Query!
Recruitment postcode(s) [3]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
2228 - Miranda
Query!
Recruitment postcode(s) [5]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [6]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [7]
0
0
2035 - Sydney
Query!
Recruitment postcode(s) [8]
0
0
4075 - Sherwood
Query!
Recruitment postcode(s) [9]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [10]
0
0
5006 - North Adelaide
Query!
Recruitment postcode(s) [11]
0
0
3124 - Camberwell
Query!
Recruitment postcode(s) [12]
0
0
3144 - Melbourne
Query!
Recruitment postcode(s) [13]
0
0
3168 - Melbourne
Query!
Recruitment postcode(s) [14]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [15]
0
0
6100 - Victoria Park
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Delaware
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Florida
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Georgia
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Hawaii
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Idaho
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Illinois
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Indiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Kansas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Kentucky
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Louisiana
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Maryland
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Massachusetts
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Michigan
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Mississippi
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Missouri
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Nebraska
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Nevada
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
New Hampshire
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
New Jersey
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
New Mexico
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
New York
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
North Carolina
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
North Dakota
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Ohio
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Oklahoma
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Pennsylvania
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
South Carolina
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Tennessee
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Texas
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Utah
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Virginia
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Washington
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Minas Gerais
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
RJ
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
SP
Query!
Country [42]
0
0
Bulgaria
Query!
State/province [42]
0
0
Plovdiv
Query!
Country [43]
0
0
Bulgaria
Query!
State/province [43]
0
0
Ruse
Query!
Country [44]
0
0
Bulgaria
Query!
State/province [44]
0
0
Sofia
Query!
Country [45]
0
0
Colombia
Query!
State/province [45]
0
0
Antioquia
Query!
Country [46]
0
0
Colombia
Query!
State/province [46]
0
0
Bogota DC
Query!
Country [47]
0
0
Croatia
Query!
State/province [47]
0
0
Zagreb
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Aichi
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Chiba
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Fukuoka
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Fukushima
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Gunma
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Hiroshima
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Hokkaido
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Hyogo
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Ibaraki
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Ishikawa
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Kanagawa
Query!
Country [59]
0
0
Japan
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State/province [59]
0
0
Kyoto
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Country [60]
0
0
Japan
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State/province [60]
0
0
Miyagi
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Country [61]
0
0
Japan
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State/province [61]
0
0
Nagano
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Country [62]
0
0
Japan
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State/province [62]
0
0
Oita
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Country [63]
0
0
Japan
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State/province [63]
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0
Osaka
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Country [64]
0
0
Japan
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State/province [64]
0
0
Shimane
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Country [65]
0
0
Japan
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State/province [65]
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0
Shizuoka
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Country [66]
0
0
Japan
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State/province [66]
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Tokyo
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Country [67]
0
0
Japan
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State/province [67]
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0
Tottori
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Country [68]
0
0
Japan
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State/province [68]
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0
Kumamoto
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Country [69]
0
0
Japan
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State/province [69]
0
0
Saitama
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Country [70]
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0
Korea, Republic of
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State/province [70]
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0
Daegu
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Country [71]
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0
Korea, Republic of
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State/province [71]
0
0
Daejeon
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Country [72]
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0
Korea, Republic of
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State/province [72]
0
0
Gwangju
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Country [73]
0
0
Korea, Republic of
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State/province [73]
0
0
Seoul
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Country [74]
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0
Korea, Republic of
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State/province [74]
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0
Yangcheon-gu, Seoul
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Country [75]
0
0
Lithuania
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State/province [75]
0
0
Kaunas
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Country [76]
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0
Lithuania
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State/province [76]
0
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Klaipeda
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Country [77]
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Lithuania
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State/province [77]
0
0
Siauliai
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Country [78]
0
0
Mexico
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State/province [78]
0
0
Jalisco
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Country [79]
0
0
New Zealand
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State/province [79]
0
0
BOP
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Country [80]
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0
New Zealand
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State/province [80]
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0
Otago
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Country [81]
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0
New Zealand
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State/province [81]
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Auckland
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Country [82]
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0
New Zealand
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State/province [82]
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0
Christchurch
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Country [83]
0
0
New Zealand
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State/province [83]
0
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Nelson
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Country [84]
0
0
New Zealand
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State/province [84]
0
0
Tauranga
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Country [85]
0
0
New Zealand
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State/province [85]
0
0
Wellington
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Country [86]
0
0
Peru
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State/province [86]
0
0
Arequipa
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Country [87]
0
0
Peru
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State/province [87]
0
0
LA Libertad
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Country [88]
0
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Peru
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State/province [88]
0
0
Lima
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Country [89]
0
0
Philippines
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State/province [89]
0
0
NCR
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Country [90]
0
0
Philippines
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State/province [90]
0
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Manila
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Country [91]
0
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Russian Federation
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State/province [91]
0
0
Moscow
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Country [92]
0
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Russian Federation
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State/province [92]
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0
Novosibirsk
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Country [93]
0
0
Russian Federation
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State/province [93]
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0
Ryazan
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Country [94]
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Russian Federation
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State/province [94]
0
0
Saint Petersburg
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Country [95]
0
0
Serbia
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State/province [95]
0
0
Belgrade
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Country [96]
0
0
Serbia
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State/province [96]
0
0
Niska Banja
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Country [97]
0
0
Serbia
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State/province [97]
0
0
Novi Sad
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Country [98]
0
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Serbia
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State/province [98]
0
0
Sabac
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Country [99]
0
0
Slovakia
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State/province [99]
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0
Bratislava
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Country [100]
0
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Slovakia
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State/province [100]
0
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Kosice
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Country [101]
0
0
Slovakia
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State/province [101]
0
0
Nove Mesto nad Vahom
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Country [102]
0
0
Slovakia
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State/province [102]
0
0
Piestany
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Country [103]
0
0
Taiwan
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State/province [103]
0
0
Changhua
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Country [104]
0
0
Taiwan
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State/province [104]
0
0
Kaohsiung
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Country [105]
0
0
Taiwan
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State/province [105]
0
0
Taichung
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Country [106]
0
0
Ukraine
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State/province [106]
0
0
Chernivtsi
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Country [107]
0
0
Ukraine
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State/province [107]
0
0
Kharkiv
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Country [108]
0
0
Ukraine
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State/province [108]
0
0
Kyiv
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Country [109]
0
0
Ukraine
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State/province [109]
0
0
Lviv
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Country [110]
0
0
Ukraine
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State/province [110]
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0
Odesa
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Country [111]
0
0
Ukraine
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State/province [111]
0
0
Ternopil
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Country [112]
0
0
Ukraine
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State/province [112]
0
0
Vinnytsia
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Country [113]
0
0
Ukraine
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State/province [113]
0
0
Zaporizhzhya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare the long-term joint safety and efficacy (pain relief)
of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory
drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02528188
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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Country
0
0
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Phone
0
0
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Fax
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0
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Email
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0
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02528188
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