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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/NCT01877668
Registration number
NCT01877668
Ethics application status
Date submitted
12/06/2013
Date registered
14/06/2013
Date last updated
6/07/2017
Titles & IDs
Public title
Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
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Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis
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Secondary ID [1]
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2011-003668-55
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Secondary ID [2]
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A3921091
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Universal Trial Number (UTN)
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Trial acronym
OPAL BROADEN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic 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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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tofacitinib 5 mg BID
Treatment: Drugs - Tofacitinib 10 mg BID
Treatment: Drugs - Adalimumab
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Experimental: Tofacitinib 5 mgBID x 12 months -
Experimental: Tofacitinib 10 mg BID x 12 months -
Active Comparator: Adalimumab 40 mg q2 weeks x 12 months -
Placebo Comparator: Placebo x3 months, then tofacitinib 5 mg BIDx 9 months -
Placebo Comparator: Placebo x 3 months, then tofacitinib 10 mg BID x 9 months -
Treatment: Drugs: Tofacitinib 5 mg BID
Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
Treatment: Drugs: Tofacitinib 10 mg BID
Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
Treatment: Drugs: Adalimumab
Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
Treatment: Drugs: Placebo
Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months
Treatment: Drugs: Placebo
Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months
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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 Meeting American College of Rheumatology Response Criteria =20% (ACR20): Month 3
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Assessment method [1]
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ACR20 was calculated as a =20% improvement from baseline in tender/painful and swollen joint counts and =20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).
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Timepoint [1]
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At end of Month 3
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Primary outcome [2]
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Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
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Assessment method [2]
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The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.
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Timepoint [2]
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From Baseline to Month 3
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Secondary outcome [1]
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Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis
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Assessment method [1]
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Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing.
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Timepoint [1]
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From Baseline to Month 12
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Secondary outcome [2]
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Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12
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Assessment method [2]
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Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS >0.5 from baseline.
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Timepoint [2]
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At Month 12
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Secondary outcome [3]
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Percentage of Participants Meeting American College of Rheumatology Response Criteria =50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
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Assessment method [3]
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ACR50 was calculated as a =50% improvement from baseline in tender/painful and swollen joint counts and =50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.
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Timepoint [3]
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At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
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Secondary outcome [4]
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Percentage of Participants Meeting American College of Rheumatology Response Criteria =70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
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Assessment method [4]
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ACR70 was calculated as a =70% improvement from baseline in tender/painful and swollen joint counts and =70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.
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Timepoint [4]
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At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
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Secondary outcome [5]
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Percentage of Participants Meeting American College of Rheumatology Response Criteria =20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12
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Assessment method [5]
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ACR20 was calculated as a =20% improvement from baseline in tender/painful and swollen joint counts and =20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.
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Timepoint [5]
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At Week 2 and Months 1, 2, 4, 6, 9, and 12
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Secondary outcome [6]
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Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
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Assessment method [6]
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The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.
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Timepoint [6]
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From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12
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Secondary outcome [7]
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Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels
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Assessment method [7]
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
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Timepoint [7]
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From Baseline to end of Month 3
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Secondary outcome [8]
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Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain
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Assessment method [8]
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Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
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Timepoint [8]
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From Baseline to end of Month 3
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Secondary outcome [9]
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Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis
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Assessment method [9]
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Participant answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).
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Timepoint [9]
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From Baseline to end of Month 3
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Secondary outcome [10]
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Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis
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Assessment method [10]
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The blinded investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
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Timepoint [10]
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From Baseline to end of Month 3
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Secondary outcome [11]
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Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count
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Assessment method [11]
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Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.
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Timepoint [11]
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From Baseline to end of Month 3
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Secondary outcome [12]
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Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count
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Assessment method [12]
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Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.
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Timepoint [12]
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From Baseline to end of Month 3
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Secondary outcome [13]
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Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
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Assessment method [13]
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The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: =20% improvement in Physician's Global Assessment of Arthritis; =20% improvement in Patient's Global Assessment of Arthritis; =30% improvement in tender joint count; and =30% improvement in swollen joint count.
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Timepoint [13]
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At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
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Secondary outcome [14]
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Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response
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Assessment method [14]
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The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
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Timepoint [14]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [15]
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Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12
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Assessment method [15]
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PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis & is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.
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Timepoint [15]
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At Months 1, 3, 6, 9, and 12
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Secondary outcome [16]
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Change From Baseline in Dactylitis Severity Score (DSS)
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Assessment method [16]
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Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness.
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Timepoint [16]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [17]
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Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
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Assessment method [17]
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The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.
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Timepoint [17]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [18]
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Change From Baseline in the Leeds Enthesitis Index (LEI)
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Assessment method [18]
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Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0-6. Higher score indicates a greater number of sites that are affected by enthesitis.
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Timepoint [18]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [19]
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Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score
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Assessment method [19]
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The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.
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Timepoint [19]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [20]
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Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score
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Assessment method [20]
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The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.
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Timepoint [20]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [21]
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Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain
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Assessment method [21]
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The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning.
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Timepoint [21]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [22]
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Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain
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Assessment method [22]
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The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning.
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Timepoint [22]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [23]
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Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain
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Assessment method [23]
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The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain.
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Timepoint [23]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [24]
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Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain
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Assessment method [24]
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The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions.
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Timepoint [24]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [25]
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Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain
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Assessment method [25]
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The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality.
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Timepoint [25]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [26]
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Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain
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Assessment method [26]
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The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning.
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Timepoint [26]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [27]
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Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain
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Assessment method [27]
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0
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning.
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Timepoint [27]
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From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [28]
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Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain
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Assessment method [28]
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0
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning.
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Timepoint [28]
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0
From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [29]
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Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility
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Assessment method [29]
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The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.
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Timepoint [29]
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0
From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [30]
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Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care
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Assessment method [30]
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The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.
Query!
Timepoint [30]
0
0
From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [31]
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Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities
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Assessment method [31]
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0
The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.
Query!
Timepoint [31]
0
0
From Baseline to Months 1, 3, 6, 9, and 12
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Secondary outcome [32]
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0
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort
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Assessment method [32]
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0
The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.
Query!
Timepoint [32]
0
0
From Baseline to Months 1, 3, 6, 9, and 12
Query!
Secondary outcome [33]
0
0
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression
Query!
Assessment method [33]
0
0
The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.
Query!
Timepoint [33]
0
0
From Baseline to Months 1, 3, 6, 9, and 12
Query!
Secondary outcome [34]
0
0
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today
Query!
Assessment method [34]
0
0
The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status.
Query!
Timepoint [34]
0
0
From Baseline to Months 1, 3, 6, 9, and 12
Query!
Secondary outcome [35]
0
0
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score
Query!
Assessment method [35]
0
0
FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status.
Query!
Timepoint [35]
0
0
From Baseline to Months 1, 3, 6, 9, and 12
Query!
Secondary outcome [36]
0
0
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score
Query!
Assessment method [36]
0
0
FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience.
Query!
Timepoint [36]
0
0
From Baseline to Months 1, 3, 6, 9, and 12
Query!
Secondary outcome [37]
0
0
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score
Query!
Assessment method [37]
0
0
FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning.
Query!
Timepoint [37]
0
0
From Baseline to Months 1, 3, 6, 9, and 12
Query!
Secondary outcome [38]
0
0
Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)
Query!
Assessment method [38]
0
0
BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.
Query!
Timepoint [38]
0
0
From Baseline to Months 1, 3, 6, 9, and 12
Query!
Eligibility
Key inclusion criteria
- Males or females, aged >= 18 years at time of consent.
- Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months
- Meet the Classification Criteria of PsA (CASPAR) at time of screening
- Must not have been adequately treated with a a traditional non-biologic disease
modifying anti-rheumatic drug (DMARD).
- Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and
required
- Must not have taken a biologic Tumour Necrosis Factor Inhibitor
- Must have 3 or more swollen joints AND 3 or more tender joints
- Must have active psoriasis skin lesions
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
- Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the
exception of nail psoriasis which is allowed
- Pregnant or breast feeding, females of child-bearing potential not using highly
effective contraception
- New York Heart Association Class III and IV congestive heart failure
- History of hypersensitivity or infusion reaction to biologic agents
- Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection
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 administering the treatment/s
The people assessing the outcomes
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
20/01/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
18/12/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
422
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Query!
Recruitment hospital [1]
0
0
Rheumatology Research Unit - Maroochydore
Query!
Recruitment hospital [2]
0
0
Pacific Private Clinic - Southport
Query!
Recruitment hospital [3]
0
0
Monash Health, Monash Medical Centre - Clayton
Query!
Recruitment hospital [4]
0
0
Pharmacy Clinical Trials - Clayton
Query!
Recruitment hospital [5]
0
0
St. Vincent's Hospital (Melbourne) - Fitzroy
Query!
Recruitment hospital [6]
0
0
Emeritus Research Pty Ltd - Malvern East
Query!
Recruitment postcode(s) [1]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [2]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [3]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [4]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [5]
0
0
3145 - Malvern East
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
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Maryland
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Minnesota
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Nebraska
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Hampshire
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Ohio
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Pennsylvania
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
South Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Utah
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Washington
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Brussels
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Leuven
Query!
Country [18]
0
0
Bulgaria
Query!
State/province [18]
0
0
Pleven
Query!
Country [19]
0
0
Bulgaria
Query!
State/province [19]
0
0
Plovdiv
Query!
Country [20]
0
0
Bulgaria
Query!
State/province [20]
0
0
Sofia
Query!
Country [21]
0
0
Bulgaria
Query!
State/province [21]
0
0
Stara Zagora
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Alberta
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Ontario
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Quebec
Query!
Country [25]
0
0
Czechia
Query!
State/province [25]
0
0
Czech Republic
Query!
Country [26]
0
0
Czechia
Query!
State/province [26]
0
0
Brno
Query!
Country [27]
0
0
Czechia
Query!
State/province [27]
0
0
Ostrava
Query!
Country [28]
0
0
Czechia
Query!
State/province [28]
0
0
Praha 1- Nove Mesto
Query!
Country [29]
0
0
Czechia
Query!
State/province [29]
0
0
Praha 2
Query!
Country [30]
0
0
Czechia
Query!
State/province [30]
0
0
Uherske Hradiste
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Corbeil Essonnes cedex
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Berlin
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Koeln
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Schwerin
Query!
Country [35]
0
0
Hungary
Query!
State/province [35]
0
0
Budapest
Query!
Country [36]
0
0
Hungary
Query!
State/province [36]
0
0
Veszprem
Query!
Country [37]
0
0
Mexico
Query!
State/province [37]
0
0
Jalisco
Query!
Country [38]
0
0
Mexico
Query!
State/province [38]
0
0
Sinaloa
Query!
Country [39]
0
0
Mexico
Query!
State/province [39]
0
0
Yucatan
Query!
Country [40]
0
0
Mexico
Query!
State/province [40]
0
0
Chihuahua
Query!
Country [41]
0
0
Mexico
Query!
State/province [41]
0
0
Mexico City
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Bialystok
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Bydgoszcz
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Elblag
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Grodzisk Mazowiecki
Query!
Country [46]
0
0
Poland
Query!
State/province [46]
0
0
Lublin
Query!
Country [47]
0
0
Poland
Query!
State/province [47]
0
0
Nadarzyn
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Poznan
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Torun
Query!
Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Warsaw
Query!
Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Warszawa
Query!
Country [52]
0
0
Poland
Query!
State/province [52]
0
0
Wroclaw
Query!
Country [53]
0
0
Russian Federation
Query!
State/province [53]
0
0
Karelia Republic
Query!
Country [54]
0
0
Russian Federation
Query!
State/province [54]
0
0
Moscow
Query!
Country [55]
0
0
Russian Federation
Query!
State/province [55]
0
0
Novosibirsk
Query!
Country [56]
0
0
Russian Federation
Query!
State/province [56]
0
0
Saratov
Query!
Country [57]
0
0
Russian Federation
Query!
State/province [57]
0
0
Tomsk
Query!
Country [58]
0
0
Russian Federation
Query!
State/province [58]
0
0
Yaroslavl
Query!
Country [59]
0
0
Slovakia
Query!
State/province [59]
0
0
Slovak Republic
Query!
Country [60]
0
0
Slovakia
Query!
State/province [60]
0
0
Bratislava
Query!
Country [61]
0
0
Slovakia
Query!
State/province [61]
0
0
Rimavska Sobota
Query!
Country [62]
0
0
Spain
Query!
State/province [62]
0
0
A Coruna
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Barcelona
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Cantabria
Query!
Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Sevilla
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
Valencia
Query!
Country [67]
0
0
Taiwan
Query!
State/province [67]
0
0
Taiwan Roc
Query!
Country [68]
0
0
Taiwan
Query!
State/province [68]
0
0
Chia-Yi
Query!
Country [69]
0
0
Taiwan
Query!
State/province [69]
0
0
Kaohsiung
Query!
Country [70]
0
0
Taiwan
Query!
State/province [70]
0
0
Taichung
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
Essex
Query!
Country [72]
0
0
United Kingdom
Query!
State/province [72]
0
0
West Midlands
Query!
Country [73]
0
0
United Kingdom
Query!
State/province [73]
0
0
West Yorkshire
Query!
Country [74]
0
0
United Kingdom
Query!
State/province [74]
0
0
Wirral
Query!
Country [75]
0
0
United Kingdom
Query!
State/province [75]
0
0
York
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a 12-month study investigating the effectiveness and safety of tofactinib in treating
the signs and symptoms of active psoriatic arthritis and improving physical function and
preserving bone structure in patients with an inadequate response to a traditional,
nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01877668
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01877668
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