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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/NCT00106535
Registration number
NCT00106535
Ethics application status
Date submitted
25/03/2005
Date registered
28/03/2005
Date last updated
6/02/2014
Titles & IDs
Public title
A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
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Scientific title
A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis
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Secondary ID [1]
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WA17823
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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:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tocilizumab [RoActemra/Actemra]
Treatment: Drugs - Placebo
Treatment: Drugs - Methotrexate
Experimental: Tocilizumab 4 mg/kg + Methotrexate - Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
Experimental: Tocilizumab 8 mg/kg + Methotrexate - Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
Placebo Comparator: Placebo + Methotrexate - Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
Treatment: Drugs: tocilizumab [RoActemra/Actemra]
4 mg/kg or 8 mg/kg IV/month every 4 weeks.
Treatment: Drugs: Placebo
IV/month
Treatment: Drugs: Methotrexate
10-25 mg/week
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Intervention code [1]
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Treatment: Drugs
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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 American College of Rheumatology-ACR20 Response
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Assessment method [1]
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ACR20 response is defined as a = 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
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Timepoint [1]
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Baseline, Week 24
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Primary outcome [2]
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Change From Baseline in Modified Total Sharp-Genant Score at Week 52
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Assessment method [2]
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Radiographs were taken of each hand and foot at Baseline and Week 52 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 (normalized from 98) and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 (normalized from 104) and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.
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Timepoint [2]
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Baseline, Week 52
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Primary outcome [3]
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Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52
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Assessment method [3]
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HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 52 HAQ-DI score, the AUC of the change from baseline was standardized to 52 weeks using the latest timepoint available for calculation of the AUC. The mean was adjusted for region. A negative change from baseline indicated improvement.
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Timepoint [3]
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Baseline to Week 52
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Primary outcome [4]
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Change From Baseline in the Modified Total Sharp-Genant Score at Week 104
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Assessment method [4]
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Radiographs of each hand and foot were taken at Baseline and Week 104 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.
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Timepoint [4]
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Baseline, Week 104
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Primary outcome [5]
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Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104
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Assessment method [5]
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HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 2 years by using the AUC of the change from baseline in HAQ-DI score through week 104. Decreases in AUC of change from baseline in HAQ-DI indicated a gr eater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 104 HAQ-DI score, the AUC of the change from baseline was standardized to 104 weeks using the latest timepoint available for calculation of the AUC. A negative change from baseline indicated improvement.
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Timepoint [5]
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Baseline to Week 104
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Secondary outcome [1]
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Percentage of Participants With ACR50 Response
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Assessment method [1]
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ACR50 response is defined as a = 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [2]
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Percentage of Participants With ACR70 Response
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Assessment method [2]
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0
ACR70 response is defined as a = 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].
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Timepoint [2]
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Baseline,Week 24
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Secondary outcome [3]
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Swollen Joint Count (66 Joint Count): Mean Change From Baseline at Week 24
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Assessment method [3]
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66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.
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Timepoint [3]
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Baseline, Week 24
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Secondary outcome [4]
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Tender Joint Count (68 Joint Count): Mean Change From Baseline at Week 24
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Assessment method [4]
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68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
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Timepoint [4]
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Baseline, Week 24
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Secondary outcome [5]
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Patient's Global Visual Analog Scale (VAS): Mean Change From Baseline at Week 24
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Assessment method [5]
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The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
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Timepoint [5]
0
0
Baseline, Week 24
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Secondary outcome [6]
0
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Physician's Global VAS: Mean Change From Baseline at Week 24
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Assessment method [6]
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0
The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity).
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Timepoint [6]
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0
Baseline, Week 24
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Secondary outcome [7]
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Patient's Pain VAS: Mean Change From Baseline at Week 24
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Assessment method [7]
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The patient assessed their pain on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change indicated improvement.
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Timepoint [7]
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0
Baseline and Week 24
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Secondary outcome [8]
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C-Reactive Protein (CRP): Mean Change From Baseline at Week 24
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Assessment method [8]
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The serum concentration of C-Reactive Protein (CRP) is measured in mg/dL. A reduction in the level is considered an improvement.
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Timepoint [8]
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Baseline, Week 24
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Secondary outcome [9]
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Erythrocyte Sedimentation Rate: Mean Change From Baseline at Week 24
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Assessment method [9]
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The Erythrocyte Sedimentation Rate (ESR) was measured in mm/hr. A reduction in the level is considered an improvement.
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Timepoint [9]
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0
Baseline, Week 24
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Secondary outcome [10]
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Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Week 24
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Assessment method [10]
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HAQ-DI is a self-completed patient questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.
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Timepoint [10]
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0
Baseline, Week 24
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Secondary outcome [11]
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Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 52
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Assessment method [11]
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0
ACR20 response is defined as a = 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
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Timepoint [11]
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0
Baseline, Week 52
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Secondary outcome [12]
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Percentage of Participants With ACR20 Response at Week 104
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Assessment method [12]
0
0
ACR20 response is defined as a = 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
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Timepoint [12]
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Baseline, Week 104
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Secondary outcome [13]
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Percentage of Participants With ACR50 Response at Week 52
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Assessment method [13]
0
0
ACR50 response is defined as a = 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
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Timepoint [13]
0
0
Baseline, Week 52
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Secondary outcome [14]
0
0
Percentage of Participants With ACR50 Response at Week 104
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Assessment method [14]
0
0
ACR50 response is defined as a = 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
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Timepoint [14]
0
0
Baseline, Week 104
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Secondary outcome [15]
0
0
Percentage of Participants With ACR70 Response at Week 52
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Assessment method [15]
0
0
ACR70 response is defined as a = 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
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Timepoint [15]
0
0
Baseline, Week 52
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Secondary outcome [16]
0
0
Percentage of Participants With ACR70 Response at Week 104
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Assessment method [16]
0
0
ACR50 response is defined as a = 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
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Timepoint [16]
0
0
Baseline, Week 104
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Secondary outcome [17]
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Percentage of Participants With ACR70 Response Maintained for 6 Consecutive Months
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Assessment method [17]
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0
ACR70 response is defined as a = 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
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Timepoint [17]
0
0
104 Weeks
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Secondary outcome [18]
0
0
Change From Baseline in Swollen Joint Count at Week 52
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Assessment method [18]
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0
66 joints were assessed at Baseline and Week 52 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.
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Timepoint [18]
0
0
Baseline, Week 52
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Secondary outcome [19]
0
0
Change From Baseline in Tender Joint Count at Week 52
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Assessment method [19]
0
0
68 joints were assessed at Baseline and Week 52 for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.
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Timepoint [19]
0
0
Baseline, Week 52
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Secondary outcome [20]
0
0
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 52
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Assessment method [20]
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0
The patient's global assessment of disease activity is assessed at Baseline and Week 52 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
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Timepoint [20]
0
0
Baseline, Week 52
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Secondary outcome [21]
0
0
Change From Baseline in Physicians Global Assessment of Disease Activity at Week 52
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Assessment method [21]
0
0
The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
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Timepoint [21]
0
0
Baseline, Week 52
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Secondary outcome [22]
0
0
Change From Baseline in the Patient's Pain VAS at Week 52
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Assessment method [22]
0
0
The patient assessed their pain at Baseline and Week 52 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change from Baseline indicated improvement.
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Timepoint [22]
0
0
Baseline, Week 52
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Secondary outcome [23]
0
0
Change From Baseline in C-Reactive Protein (CRP) at Week 52
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Assessment method [23]
0
0
Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 52 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.
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Timepoint [23]
0
0
Baseline, Week 52
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Secondary outcome [24]
0
0
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52
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Assessment method [24]
0
0
Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 52 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.
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Timepoint [24]
0
0
Baseline, Week 52
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Secondary outcome [25]
0
0
Change From Baseline in Swollen Joint Count at Week 104
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Assessment method [25]
0
0
66 joints were assessed at Baseline and Week 104 for swelling and joints were classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.
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Timepoint [25]
0
0
Baseline, Week 104
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Secondary outcome [26]
0
0
Change From Baseline in Tender Joint Count at Week 104
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Assessment method [26]
0
0
68 joints were assessed for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.
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Timepoint [26]
0
0
Baseline, Week 104
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Secondary outcome [27]
0
0
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 104
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Assessment method [27]
0
0
The patient's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
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Timepoint [27]
0
0
Baseline, Week 104
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Secondary outcome [28]
0
0
Change From Baseline in Physicians Global Assessment of Disease Activity at Week 104
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Assessment method [28]
0
0
The physician's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Query!
Timepoint [28]
0
0
Baseline, Week 104
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Secondary outcome [29]
0
0
Change From Baseline in the Patient's Pain VAS at Week 104
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Assessment method [29]
0
0
The patient assessed their pain at Baseline and Week 104 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change from Baseline indicated improvement.
Query!
Timepoint [29]
0
0
Baseline, Week 104
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Secondary outcome [30]
0
0
Change From Baseline in C-Reactive Protein (CRP) at Week 104
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Assessment method [30]
0
0
Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 104 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.
Query!
Timepoint [30]
0
0
Baseline, Week 104
Query!
Secondary outcome [31]
0
0
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 104
Query!
Assessment method [31]
0
0
Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 104 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.
Query!
Timepoint [31]
0
0
Baseline, Week 104
Query!
Secondary outcome [32]
0
0
Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 52
Query!
Assessment method [32]
0
0
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).
Query!
Timepoint [32]
0
0
Baseline, Week 52
Query!
Secondary outcome [33]
0
0
Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 104
Query!
Assessment method [33]
0
0
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).
.
Query!
Timepoint [33]
0
0
Baseline, Week 104
Query!
Secondary outcome [34]
0
0
Area Under Curve (AUC) of the ACRn to Week 24
Query!
Assessment method [34]
0
0
The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 24. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.
Query!
Timepoint [34]
0
0
24 Weeks
Query!
Secondary outcome [35]
0
0
Area Under Curve (AUC) of the ACRn to Week 52
Query!
Assessment method [35]
0
0
The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 52. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.
Query!
Timepoint [35]
0
0
52 Weeks
Query!
Secondary outcome [36]
0
0
Area Under Curve (AUC) of the ACRn Score at Week 104
Query!
Assessment method [36]
0
0
The ACRn is defined as each patient's lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 104. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.
Query!
Timepoint [36]
0
0
104 Weeks
Query!
Secondary outcome [37]
0
0
Change From Baseline in Disease Activity Score (DAS28) at Week 24
Query!
Assessment method [37]
0
0
The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
Query!
Timepoint [37]
0
0
Baseline, Week 24
Query!
Secondary outcome [38]
0
0
Change From Baseline in Disease Activity Score (DAS28) at Week 52
Query!
Assessment method [38]
0
0
The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
Query!
Timepoint [38]
0
0
Baseline, Week 52
Query!
Secondary outcome [39]
0
0
Change From Baseline in Disease Activity Score (DAS28) at Week 104
Query!
Assessment method [39]
0
0
The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
Query!
Timepoint [39]
0
0
Baseline, Week 104
Query!
Secondary outcome [40]
0
0
Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 24
Query!
Assessment method [40]
0
0
The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
European League Against Rheumatism (EULAR) Good response: DAS28 = 3.2 and a change from Baseline < -1.2.
EULAR Moderate response: DAS28 >3.2 to = 5.1 or a change from Baseline < -0.6 to = -1.2.
Query!
Timepoint [40]
0
0
Baseline, Week 24
Query!
Secondary outcome [41]
0
0
Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 52
Query!
Assessment method [41]
0
0
The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
European League Against Rheumatism (EULAR) Good response: DAS28 = 3.2 and a change from Baseline < -1.2.
EULAR Moderate response: DAS28 >3.2 to = 5.1 or a change from Baseline < -0.6 to = -1.2.
Query!
Timepoint [41]
0
0
Baseline, Week 52
Query!
Secondary outcome [42]
0
0
Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 104
Query!
Assessment method [42]
0
0
The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.
European League Against Rheumatism (EULAR) Good response: DAS28 = 3.2 and a change from Baseline < -1.2.
EULAR Moderate response: DAS28 >3.2 to = 5.1 or a change from Baseline < -0.6 to = -1.2.
Query!
Timepoint [42]
0
0
Baseline, Week 104
Query!
Secondary outcome [43]
0
0
Percentage of Participants With DAS28 Remission at Week 24
Query!
Assessment method [43]
0
0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 remission is defined as a DAS28 score <2.6.
Query!
Timepoint [43]
0
0
Week 24
Query!
Secondary outcome [44]
0
0
Percentage of Participants With DAS28 Remission at Week 52
Query!
Assessment method [44]
0
0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control.DAS28 Remission is defined as a DAS28 score <2.6.
Query!
Timepoint [44]
0
0
Week 52
Query!
Secondary outcome [45]
0
0
Percentage of Participants With DAS28 Remission at Week 104
Query!
Assessment method [45]
0
0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.
Query!
Timepoint [45]
0
0
Week 104
Query!
Secondary outcome [46]
0
0
Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 24
Query!
Assessment method [46]
0
0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).
Query!
Timepoint [46]
0
0
24 Weeks
Query!
Secondary outcome [47]
0
0
Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 52
Query!
Assessment method [47]
0
0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).
Query!
Timepoint [47]
0
0
52 Weeks
Query!
Secondary outcome [48]
0
0
Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 104
Query!
Assessment method [48]
0
0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).
Query!
Timepoint [48]
0
0
104 Weeks
Query!
Secondary outcome [49]
0
0
Change From Baseline in Modified Total Sharp-Genant Score at Week 24
Query!
Assessment method [49]
0
0
Radiographs were taken of each hand and foot at Baseline and Week 24 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.
Query!
Timepoint [49]
0
0
Baseline, Week 24
Query!
Secondary outcome [50]
0
0
Change From Baseline in Modified Total Sharp-Genant Score at Week 80
Query!
Assessment method [50]
0
0
Radiographs were taken of each hand and foot at Baseline and Week 80 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.
Query!
Timepoint [50]
0
0
Baseline, Week 80
Query!
Secondary outcome [51]
0
0
Change From Baseline in Erosion Score at Week 24
Query!
Assessment method [51]
0
0
Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.
Query!
Timepoint [51]
0
0
Baseline, Week 24
Query!
Secondary outcome [52]
0
0
Change From Baseline in Erosion Score at Week 52
Query!
Assessment method [52]
0
0
Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.
Query!
Timepoint [52]
0
0
Baseline, Week 52
Query!
Secondary outcome [53]
0
0
Change From Baseline in Erosion Score at Week 80
Query!
Assessment method [53]
0
0
Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.
Query!
Timepoint [53]
0
0
Baseline, Week 80
Query!
Secondary outcome [54]
0
0
Change From Baseline in Erosion Score at Week 104
Query!
Assessment method [54]
0
0
Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.
Query!
Timepoint [54]
0
0
Baseline, Week 104
Query!
Secondary outcome [55]
0
0
Change From Baseline in Joint Space Narrowing Score at Week 24
Query!
Assessment method [55]
0
0
Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower change from Baseline indicated a better score.
Query!
Timepoint [55]
0
0
Baseline, Week 24
Query!
Secondary outcome [56]
0
0
Change From Baseline in Joint Space Narrowing Score at Week 52
Query!
Assessment method [56]
0
0
Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.
Query!
Timepoint [56]
0
0
Baseline, Week 52
Query!
Secondary outcome [57]
0
0
Change From Baseline in Joint Space Narrowing Score at Week 80
Query!
Assessment method [57]
0
0
Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.
Query!
Timepoint [57]
0
0
Baseline, Week 80
Query!
Secondary outcome [58]
0
0
Change From Baseline in Joint Space Narrowing Score at Week 104
Query!
Assessment method [58]
0
0
Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.
Query!
Timepoint [58]
0
0
Baseline, Week 104
Query!
Secondary outcome [59]
0
0
Percentage of Participants With no Progression of Erosion at Week 24
Query!
Assessment method [59]
0
0
Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.
Query!
Timepoint [59]
0
0
Baseline, Week 24
Query!
Secondary outcome [60]
0
0
Percentage of Participants With no Progression of Erosion at Week 52
Query!
Assessment method [60]
0
0
Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.
Query!
Timepoint [60]
0
0
Baseline, Week 52
Query!
Secondary outcome [61]
0
0
Percentage of Participants With no Progression of Erosion at Week 104
Query!
Assessment method [61]
0
0
Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.
Query!
Timepoint [61]
0
0
Baseline, Week 104
Query!
Secondary outcome [62]
0
0
Percentage of Participants With no Progression of Joint Space Narrowing at Week 24
Query!
Assessment method [62]
0
0
Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score was defined as a change from Baseline of less than or equal to zero.
Query!
Timepoint [62]
0
0
Baseline, Week 24
Query!
Secondary outcome [63]
0
0
Percentage of Participants With no Progression of Joint Space Narrowing at Week 52
Query!
Assessment method [63]
0
0
Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.
Query!
Timepoint [63]
0
0
Baseline, Week 52
Query!
Secondary outcome [64]
0
0
Percentage of Participants With no Progression of Joint Space Narrowing at Week 104
Query!
Assessment method [64]
0
0
Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.
Query!
Timepoint [64]
0
0
Baseline, Week 104
Query!
Secondary outcome [65]
0
0
Change From Baseline in HAQ Disability Index (HAQ-DI) at Week 52
Query!
Assessment method [65]
0
0
HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.
Query!
Timepoint [65]
0
0
Baseline, Week 52
Query!
Secondary outcome [66]
0
0
Change From Baseline in HAQ Disability Index at Week 104
Query!
Assessment method [66]
0
0
HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8). Total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.
Query!
Timepoint [66]
0
0
Baseline, Week 104
Query!
Secondary outcome [67]
0
0
Change From Baseline in Quality Life Short Form-36 (SF-36) Score at Week 24
Query!
Assessment method [67]
0
0
The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.
Query!
Timepoint [67]
0
0
Baseline, Week 24
Query!
Secondary outcome [68]
0
0
Change From Baseline in SF-36 Score at Week 52
Query!
Assessment method [68]
0
0
The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicates improvement.
Query!
Timepoint [68]
0
0
Baseline, Week 52
Query!
Secondary outcome [69]
0
0
Change From Baseline in SF-36 Score at Week 104
Query!
Assessment method [69]
0
0
The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.
Query!
Timepoint [69]
0
0
Baseline, Week 104
Query!
Secondary outcome [70]
0
0
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score at Week 24
Query!
Assessment method [70]
0
0
FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.
Query!
Timepoint [70]
0
0
Baseline, Week 24
Query!
Secondary outcome [71]
0
0
Change From Baseline in FACIT-F Score at Week 52
Query!
Assessment method [71]
0
0
FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.
Query!
Timepoint [71]
0
0
Baseline, Week 52
Query!
Secondary outcome [72]
0
0
Change From Baseline in FACIT-F Score at Week 104
Query!
Assessment method [72]
0
0
FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.
Query!
Timepoint [72]
0
0
Baseline, Week 104
Query!
Secondary outcome [73]
0
0
Change From Baseline in Rheumatoid Factor (RF) at Week 24 in Those Patients With Positive RF
Query!
Assessment method [73]
0
0
Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 24 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.
Query!
Timepoint [73]
0
0
Baseline, Week 24
Query!
Secondary outcome [74]
0
0
Change From Baseline in Rheumatoid Factor (RF) at Week 52 in Those Patients With Positive RF
Query!
Assessment method [74]
0
0
Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 52 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.
Query!
Timepoint [74]
0
0
Baseline, Week 52
Query!
Secondary outcome [75]
0
0
Change From Baseline in Rheumatoid Factor (RF) at Week 104 in Those Patients With Positive RF
Query!
Assessment method [75]
0
0
Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 104 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.
Query!
Timepoint [75]
0
0
Baseline, Week 104
Query!
Secondary outcome [76]
0
0
Time to Onset of ACR20 by Treatment Group
Query!
Assessment method [76]
0
0
Time in days until ACR20 response. ACR20 response was defined as a = 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
Query!
Timepoint [76]
0
0
6 months
Query!
Secondary outcome [77]
0
0
Time to Onset of ACR50 by Treatment Group
Query!
Assessment method [77]
0
0
Time in days until ACR50 response. ACR50 response was defined as a = 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
Query!
Timepoint [77]
0
0
6 months
Query!
Secondary outcome [78]
0
0
Time to Onset of ACR70 by Treatment Group
Query!
Assessment method [78]
0
0
Time in days until ACR70 response. ACR70 response is defined as a = 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
Query!
Timepoint [78]
0
0
6 months
Query!
Secondary outcome [79]
0
0
Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response
Query!
Assessment method [79]
0
0
Insufficient therapeutic response (patient not responding to the drug as assessed by the physician) was selected by the investigator as a reason that the patient withdrew from the study.
Query!
Timepoint [79]
0
0
104 Weeks
Query!
Secondary outcome [80]
0
0
Percentage of Participants in Each Treatment Group Who Receive Escape Therapy
Query!
Assessment method [80]
0
0
In Escape 1, participants in the Tocilizumab 4 mg/kg + Methotrexate and Tocilizumab 8 mg/kg + Methotrexate groups received tocilizumab 8 mg/kg as escape therapy. Participants in the Placebo + Methotrexate group received tocilizumab 4 mg/kg as escape therapy.
In Escape 2, all participants received tocilizumab 8 mg/kg.
Query!
Timepoint [80]
0
0
104 Weeks
Query!
Secondary outcome [81]
0
0
Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 24
Query!
Assessment method [81]
0
0
The percentage of participants, who achieved ACR remission at any study visit up to Week 24. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.
Query!
Timepoint [81]
0
0
24 Weeks
Query!
Secondary outcome [82]
0
0
Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 52
Query!
Assessment method [82]
0
0
The percentage of participants, who achieved ACR remission at any study visit up to Week 52. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.
Query!
Timepoint [82]
0
0
52 Weeks
Query!
Secondary outcome [83]
0
0
Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 104
Query!
Assessment method [83]
0
0
The percentage of participants who achieved ACR remission at any study visit up to Week 104. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.
Query!
Timepoint [83]
0
0
104 Weeks
Query!
Secondary outcome [84]
0
0
Percentage of Participants Who Achieved Complete Clinical Response at Week 52
Query!
Assessment method [84]
0
0
Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria [defined as five of the following criteria are met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR < 30 mm/hr for a female or 20 mm/hr for a male] and no radiographic progression [defined as change from baseline = 0 in the total Sharp-Genant score, erosion score, and JSN score]. Patients who achieve a complete clinical response at any time in the study are counted as responders, even if the response is not maintained.
Query!
Timepoint [84]
0
0
52 Weeks
Query!
Secondary outcome [85]
0
0
Percentage of Participants Who Achieved Complete Clinical Response at Week 104
Query!
Assessment method [85]
0
0
Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria [defined as five of the following criteria are met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR < 30 mm/hr for a female or 20 mm/hr for a male] and no radiographic progression [defined as change from baseline = 0 in the total Sharp-Genant score, erosion score, and JSN score].
Query!
Timepoint [85]
0
0
104 Weeks
Query!
Secondary outcome [86]
0
0
End of Study: Percentage of Participants With ACR Response at Week 260
Query!
Assessment method [86]
0
0
ACR20/50/70/90 response is defined as a = 20/50/70/90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.
Query!
Timepoint [86]
0
0
Baseline, Week 260
Query!
Secondary outcome [87]
0
0
End of Study: Percentage of Participants With DAS28 Remission at Week 260
Query!
Assessment method [87]
0
0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.
Query!
Timepoint [87]
0
0
Week 260
Query!
Secondary outcome [88]
0
0
End of Study: Percentage of Participants With DAS28 Low Disease Activity (LDA) at Week 260
Query!
Assessment method [88]
0
0
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDA is defined as DAS28 =3.2.
Query!
Timepoint [88]
0
0
Week 260
Query!
Secondary outcome [89]
0
0
End of Study: Percentage of Participants With DAS28 European League Against Rheumatism (EULAR) Good or Moderate Response at Week 260
Query!
Assessment method [89]
0
0
The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. EULAR Good response: DAS28 = 3.2 and a change from Baseline < -1.2. EULAR Moderate response: DAS28 >3.2 to = 5.1 or a change from Baseline < -0.6 to = -1.2.
Query!
Timepoint [89]
0
0
Baseline, Week 260
Query!
Secondary outcome [90]
0
0
End of Study: Change From Baseline in Swollen Joint Count at Week 260
Query!
Assessment method [90]
0
0
66 joints were assessed at Baseline and Week 260 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.
Query!
Timepoint [90]
0
0
Baseline, Week 260
Query!
Secondary outcome [91]
0
0
End of Study: Change From Baseline in Tender Joint Count at Week 260
Query!
Assessment method [91]
0
0
68 joints were assessed at Baseline and Week 260 for tenderness and joints are classified as tender/not tender for a total possible swollen joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.
Query!
Timepoint [91]
0
0
Baseline, Week 260
Query!
Secondary outcome [92]
0
0
End of Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 260
Query!
Assessment method [92]
0
0
HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.
Query!
Timepoint [92]
0
0
Baseline, Week 260
Query!
Secondary outcome [93]
0
0
End of Study: Change From Baseline in the Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) at Week 260
Query!
Assessment method [93]
0
0
The patient's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Query!
Timepoint [93]
0
0
Baseline, Week 260
Query!
Secondary outcome [94]
0
0
End of Study: Change From Baseline in the Physician's Global Assessment of Disease Activity VAS at Week 260
Query!
Assessment method [94]
0
0
The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Query!
Timepoint [94]
0
0
Baseline, Week 260
Query!
Secondary outcome [95]
0
0
End of Study: Change From Baseline in the Patient's Pain VAS at Week 260
Query!
Assessment method [95]
0
0
The patient assessed their pain at Baseline and Week 260 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change from Baseline indicated improvement.
Query!
Timepoint [95]
0
0
Baseline, Week 260
Query!
Secondary outcome [96]
0
0
End of Study: Percentage of Participants With Clinical Improvement in the FACIT-Fatigue Score at Week 260
Query!
Assessment method [96]
0
0
FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a =5 change from Baseline.
Query!
Timepoint [96]
0
0
Baseline, Week 260
Query!
Secondary outcome [97]
0
0
End of Study: Percentage of Participants With Clinical Relevant Improvement in the SF-36 Score at Week 260
Query!
Assessment method [97]
0
0
The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. Clinically relevant improvement is defined as a =5 change from Baseline.
Query!
Timepoint [97]
0
0
Baseline, Week 260
Query!
Secondary outcome [98]
0
0
End of Study: Change From Baseline in Total Sharp-Genant Score at Week 260
Query!
Assessment method [98]
0
0
Radiographs were taken of each hand and foot at Baseline and Week 260 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint).The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. The results were reported based on the treatment the patient was originally randomized to.
Query!
Timepoint [98]
0
0
Baseline, Week 260
Query!
Secondary outcome [99]
0
0
End of Study: Change From Baseline in Erosion Score at Week 260
Query!
Assessment method [99]
0
0
Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot and were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best ) to 142 (worst). A lower number change from Baseline indicated a better score.
Query!
Timepoint [99]
0
0
Baseline, Week 260
Query!
Secondary outcome [100]
0
0
End of Study: Change From Baseline in Joint Space Narrowing Score at Week 260
Query!
Assessment method [100]
0
0
Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.
Query!
Timepoint [100]
0
0
Baseline, Week 260
Query!
Eligibility
Key inclusion criteria
- adult patients at least 18 years of age with moderate to severe active RA for at least
6 months;
- inadequate response to a stable dose of MTX;
- patients of reproductive potential must be using reliable methods of contraception.
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
- major surgery (including joint surgery) within 8 weeks before entering study, or
planned surgery within 6 months after entering study;
- prior treatment failure with an anti-tumor necrosis factor agent;
- women who are pregnant or breast-feeding.
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
1/01/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/07/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1196
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Adelaide
Query!
Recruitment hospital [2]
0
0
- Malvern
Query!
Recruitment hospital [3]
0
0
- Melbourne
Query!
Recruitment hospital [4]
0
0
- New Lambton
Query!
Recruitment hospital [5]
0
0
- Shenton Park
Query!
Recruitment hospital [6]
0
0
- St. Leonards
Query!
Recruitment postcode(s) [1]
0
0
5011 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [3]
0
0
3168 - Melbourne
Query!
Recruitment postcode(s) [4]
0
0
2305 - New Lambton
Query!
Recruitment postcode(s) [5]
0
0
6008 - Shenton Park
Query!
Recruitment postcode(s) [6]
0
0
2139 - St. Leonards
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
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Idaho
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Montana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nevada
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Hampshire
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Jersey
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oklahoma
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oregon
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Pennsylvania
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
South Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Tennessee
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Washington
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Wisconsin
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Porto Alegre
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Rio de Janeiro
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Sao Paulo
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Beijing
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Nanjing
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Shanghai
Query!
Country [33]
0
0
Denmark
Query!
State/province [33]
0
0
Hellerup
Query!
Country [34]
0
0
Denmark
Query!
State/province [34]
0
0
Odense
Query!
Country [35]
0
0
Finland
Query!
State/province [35]
0
0
Heinola
Query!
Country [36]
0
0
Finland
Query!
State/province [36]
0
0
Helsinki
Query!
Country [37]
0
0
Finland
Query!
State/province [37]
0
0
Oulu
Query!
Country [38]
0
0
Finland
Query!
State/province [38]
0
0
Vantaa
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Amiens
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Bobigny
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Bois Guillaume
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Bordeaux
Query!
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France
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Le Kremlin Bicetre
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France
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Lille
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France
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Nice
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France
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Orleans
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France
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Paris
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France
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Strasbourg
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France
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Toulouse
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France
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Vandoeuvre-les-nancy
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Greece
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Athens
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Greece
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Heraklion
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Italy
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Brescia
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Italy
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Coppito
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Italy
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Firenze
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Italy
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Genova
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Italy
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Milano
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Italy
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Napoli
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Italy
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Padova
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Italy
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Pavia
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Italy
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Pisa
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Torino
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Italy
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Udine
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Italy
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Valeggio Sul Mincio
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Italy
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Varese
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Italy
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Verona
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Mexico
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Mexico
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Monterrey
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Mexico
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Obregon
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Norway
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Haugesund
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Norway
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Lillehammer
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Norway
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Tromsø
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Poland
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Bydgoszcz
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Dzialdowo
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Elblag
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Kalisz
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Krakow
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Poznan
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Szczecin
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Ustron
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Poland
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Warszawa
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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South Africa
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Cape Town
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South Africa
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Diepkloof
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Spain
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Barcelona
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Spain
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Cádiz
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Spain
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Merida
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Spain
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Sabadell
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Spain
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Santander
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Spain
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Sevilla
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Switzerland
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Lausanne
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Switzerland
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St. Gallen
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs
and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in
combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid
arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg
IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week.
The anticipated time on study treatment is 1-2 years and the target sample size is 500+
individuals. After completion of the 2 year study participants could participate in the
optional 3 year open label extension phase (year 3 to 5).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00106535
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00106535
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