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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/NCT02592434
Registration number
NCT02592434
Ethics application status
Date submitted
14/08/2015
Date registered
30/10/2015
Date last updated
13/04/2020
Titles & IDs
Public title
Efficacy Study Of Tofacitinib In Pediatric JIA Population
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Scientific title
EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS
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Secondary ID [1]
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2015-001438-46
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Secondary ID [2]
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A3921104
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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:
Juvenile Idiopathic 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 - CP-690,550 (tofacitinib)
Other interventions - placebo
Experimental: CP-690,550 - Treatment arm: Tofacitinib tablets or solution, according to subjects' body weights
Placebo Comparator: Placebo - Control arm: matching placebo tablets or solution for tofacitinib
Treatment: Drugs: CP-690,550 (tofacitinib)
During the open label run in phase, all subjects will receive active tofacitinib oral tablets or oral solution twice daily (BID) orally, at a dosage based on the subject's body weight as specified below.
During the double blind, placebo controlled phase, subjects will receive either active tofacitinib oral tablets/oral solution or matching placebo oral tablets/oral solution, twice daily (BID), at a dosage specified below.
Body Weight (Dosage in tablet [BID] or solution [BID]):
5<7kg (2mg or 2mL); 7<10kg(2.5mg or 2. mL); 10 <15kg (3mg or 3mL); 15<25kg (3.5mg or 3.5mL); 25<40kg (4mg or 4mL); 40kg (5 mg or 5 ml).
Oral solution (1 mg/mL) is used for subjects <40 kg. Oral tablets (5 mg) are used for subjects >=40 kg.
Other interventions: placebo
matching placebo tablet or solution for tofacitinib
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 44
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Assessment method [1]
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According to PRCSG/PRINTO, disease flare defined as worsening of >=30 percent(%) in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables: 1) Number of joints with active arthritis (joint with swelling/in absence of swelling, limited range of motion accompanied by pain/tenderness), 2)Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a Visual Analog Scale[VAS] of 0[no activity] to 10[maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0[very well] to 10[very poor], 5) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI): 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score,which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) Erythrocyte Sedimentation Rate(ESR).
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Timepoint [1]
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Week 44
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Secondary outcome [1]
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Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Week 44
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Assessment method [1]
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JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
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Timepoint [1]
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Week 44
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Secondary outcome [2]
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Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Week 44
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Assessment method [2]
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JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
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Timepoint [2]
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Week 44
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Secondary outcome [3]
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Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Week 44
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Assessment method [3]
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JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
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Timepoint [3]
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Week 44
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Secondary outcome [4]
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Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Score at Week 44
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Assessment method [4]
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CHAQ is a valid assessment of functional disability, discomfort in participants with rheumatic diseases. It comprises of three indices: Disability and Discomfort, and global assessment of arthritis (overall well-being). CHAQ-DI: as a measure of functional ability, consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on a 4-point scale of difficulty in performance ranges from 0 (no difficulty) to 3 (unable to do). To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. Scores of 8 domains were averaged to calculate the CHAQ-DI total score which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher score indicates more disability. Change from double-blind baseline at Week 44 in DI total score is reported.
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Timepoint [4]
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Baseline, Week 44
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Secondary outcome [5]
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Open-Label Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 2, 4, 8, 12 and 18
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Assessment method [5]
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According to PRCSG/PRINTO, disease flare defined as worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
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Timepoint [5]
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Weeks 2, 4, 8, 12 and 18
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Secondary outcome [6]
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Double Blind Phase: Percentage of Participants With Disease Flare According to PRCSG/PRINTO Disease Flare Criteria at Week 20, 24, 28, 32, 36 and 40
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Assessment method [6]
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According to PRCSG/PRINTO, disease flare defined as worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
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Timepoint [6]
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Weeks 20, 24, 28, 32, 36 and 40
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Secondary outcome [7]
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Open-Label Phase: Time to Disease Flare
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Assessment method [7]
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Time to disease flare:time (in days) from first dose of study drug until the day of disease flare in open-label phase. According to PRCSG/PRINTO, disease flare: worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. 6 core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
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Timepoint [7]
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Day 1 up to week 18
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Secondary outcome [8]
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Double Blind Phase: Time to Disease Flare
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Assessment method [8]
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Time to disease flare: time (in days) from first dose of study drug until the day of disease flare in double blind phase. According to PRCSG/PRINTO, disease flare: worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. 6 core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
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Timepoint [8]
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Day 1 of Week 19 up to week 44
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Secondary outcome [9]
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Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Weeks 2, 4, 8, 12 and 18
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Assessment method [9]
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JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
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Timepoint [9]
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Weeks 2, 4, 8, 12 and 18
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Secondary outcome [10]
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Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Double Blind Baseline, Weeks 20, 24, 28, 32, 36 and 40
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Assessment method [10]
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JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
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Timepoint [10]
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Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40
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Secondary outcome [11]
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Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Weeks 2, 4, 8, 12 and 18
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Assessment method [11]
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JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
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Timepoint [11]
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Weeks 2, 4, 8, 12 and 18
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Secondary outcome [12]
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Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Double Blind Baseline, Weeks 20, 24, 28, 32, 36 and 40
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Assessment method [12]
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JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
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Timepoint [12]
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Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40
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Secondary outcome [13]
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Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Weeks 2, 4, 8, 12 and 18
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Assessment method [13]
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JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
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Timepoint [13]
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Weeks 2, 4, 8, 12 and 18
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Secondary outcome [14]
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Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Double Blind Baseline (Week 18),Week 20, 24, 28, 32, 36 and 40
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Assessment method [14]
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JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
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Timepoint [14]
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Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40
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Secondary outcome [15]
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Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 90 Response at Week 2, 4, 8, 12 and 18
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Assessment method [15]
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JIA ACR90 response defined as: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.
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Timepoint [15]
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Weeks 2, 4, 8, 12 and 18
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Secondary outcome [16]
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Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 90 Response at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
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Assessment method [16]
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JIA ACR90 response defined as: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
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Timepoint [16]
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Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
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Secondary outcome [17]
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Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 100 Response at Week 2, 4, 8, 12 and 18
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Assessment method [17]
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JIA ACR100 response defined as: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
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Timepoint [17]
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0
Weeks 2, 4, 8, 12 and 18
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Secondary outcome [18]
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0
Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 100 Response at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
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Assessment method [18]
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JIA ACR100 response defined as: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.
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Timepoint [18]
0
0
Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
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Secondary outcome [19]
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0
Open Label Phase: Change From Baseline in Juvenile Arthritis Disease Activity Score 27 (JADAS-27) C-Reactive Protein (CRP) Score at Weeks 2, 4, 8, 12 and 18
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Assessment method [19]
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JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
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Timepoint [19]
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0
Baseline, Weeks 2, 4, 8, 12 and 18
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Secondary outcome [20]
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Double Blind Phase: Change From Double-Blind Baseline in Juvenile Arthritis Disease Activity Score (JADAS) 27 C-Reactive Protein (CRP) Score at Week 20, 24, 28, 32, 36, 40 and 44
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Assessment method [20]
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JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in mg/L and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
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Timepoint [20]
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0
Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
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Secondary outcome [21]
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0
Open Label Phase: Change From Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Week 2, 4, 8, 12 and 18
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Assessment method [21]
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0
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) ESR. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
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Timepoint [21]
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Baseline, weeks 2, 4, 8, 12 and 18
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Secondary outcome [22]
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Double Blind Phase: Change From Double-Blind Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Weeks 20, 24, 28, 32, 36, 40 and 44
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Assessment method [22]
0
0
JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) ESR. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Query!
Timepoint [22]
0
0
Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [23]
0
0
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Weeks 2, 4, 8, 12 and 18
Query!
Assessment method [23]
0
0
Minimum Disease Activity is defined by a JADAS-27 CRP score less than or equal to 3.8 for participants with polyarthritis, and less than or equal to 2 for participants with oligoarthritis. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(maximum of 27 defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Query!
Timepoint [23]
0
0
Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [24]
0
0
Double Blind Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [24]
0
0
Minimum Disease Activity is defined by a JADAS-27 CRP score less than or equal to 3.8 for participants with polyarthritis, and less than or equal to 2 for participants with oligoarthritis. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Query!
Timepoint [24]
0
0
Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [25]
0
0
Open-Label Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Week 2, 4, 8, 12 and 18
Query!
Assessment method [25]
0
0
JADAS-27 inactive disease is defined by a JADAS score less than or equal to 1. JADAS-27 Inactive Disease cutoff values are defined as: 1) Polyarthritis: Inactive Disease: <=1 and 2) Oligoarthritis (<4 active joints): Inactive Disease: <=1. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Query!
Timepoint [25]
0
0
Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [26]
0
0
Double Blind Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [26]
0
0
JADAS-27 inactive disease is defined by a JADAS score less than or equal to 1. JADAS-27 Inactive Disease cutoff values are defined as: 1) Polyarthritis: Inactive Disease: <=1 and 2) Oligoarthritis (<4 active joints): Inactive Disease: <=1. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Query!
Timepoint [26]
0
0
Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [27]
0
0
Double Blind Phase: Percentage of Participants With JIA ACR Inactive Disease at Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [27]
0
0
JIA ACR Inactive Disease criteria included: No joints with active arthritis, No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA, No active uveitis (as defined by the Standardized Uveitis Nomenclature (SUN) Working Group), Normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA, Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]) score of 'best possible' (score of "0") on the scale used, morning stiffness of <=15 minutes.
Query!
Timepoint [27]
0
0
Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [28]
0
0
Double Blind Phase: Percentage of Participants With Presence of JIA ACR Clinical Remission
Query!
Assessment method [28]
0
0
JIA ACR Clinical Remission Criteria included: Clinical inactive disease for 6 months continuously while on medications for JIA. Clinical Inactive Disease criteria included: No joints with active arthritis, No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA, No active uveitis (as defined by the SUN Working Group), Normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA, Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]) score of 'best possible' (score of "0") on the scale used, morning stiffness of less than or equal to (<=) 15 minutes.
Query!
Timepoint [28]
0
0
From Week 18 in double blind phase up to Week 44
Query!
Secondary outcome [29]
0
0
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Active Arthritis at Week 2, 4, 8, 12 and 18
Query!
Assessment method [29]
0
0
Number of joints with active arthritis defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness. The score range of the number of joints is from 0-71.
Query!
Timepoint [29]
0
0
Baseline, Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [30]
0
0
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Active Arthritis at Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [30]
0
0
Number of joints with active arthritis defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness. Number of joints ranged from 0 to 71.
Query!
Timepoint [30]
0
0
Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [31]
0
0
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Limited Range of Motion at Weeks 2, 4, 8, 12 and 18
Query!
Assessment method [31]
0
0
The maximum number of joints with limitation of movement was 67 and these were defined as those in the joint assessment with 'limitation of motion'.
Query!
Timepoint [31]
0
0
Baseline, Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [32]
0
0
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [32]
0
0
The maximum number of joints with limitation of movement was 67 and these were defined as those in the joint assessment with 'limitation of motion'.
Query!
Timepoint [32]
0
0
Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [33]
0
0
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Physician Global Evaluation of Disease Activity at Week 2, 4, 8, 12 and 18
Query!
Assessment method [33]
0
0
Physician global evaluation of disease activity was measured on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'No Activity' and '10' as 'Maximum Activity', higher score indicated more disease activity.
Query!
Timepoint [33]
0
0
Baseline, Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [34]
0
0
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [34]
0
0
Physician global evaluation of disease activity was measured on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'No Activity' and '10' as 'Maximum Activity', higher score indicated more disease activity.
Query!
Timepoint [34]
0
0
Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [35]
0
0
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 2, 4, 8, 12 and 18
Query!
Assessment method [35]
0
0
The parent/or legal guardian/participant rated the overall well-being on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'Very Well' and '10' as 'Very Poorly', higher scores=more disease activity.
Query!
Timepoint [35]
0
0
Baseline, Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [36]
0
0
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [36]
0
0
The parent/or legal guardian/participant rated the overall well-being on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'Very Well' and '10' as 'Very Poorly', higher scores=more disease activity.
Query!
Timepoint [36]
0
0
Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [37]
0
0
Open Label Phase: JIA ACR Core Variable- Change From Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 2, 4, 8, 12 and 18
Query!
Assessment method [37]
0
0
CHAQ is a valid assessment of functional disability, discomfort in participants with rheumatic diseases. It comprises of three indices: Disability and Discomfort, and global assessment of arthritis (overall well-being). CHAQ-DI: as a measure of functional ability, consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on a 4-point scale of difficulty in performance ranges from 0 (no difficulty) to 3 (unable to do). To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. Scores of 8 domains were averaged to calculate the CHAQ-DI total score which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher score indicates more disability. Change from baseline at Weeks 2, 4, 8, 12 and 18 in DI total score is reported.
Query!
Timepoint [37]
0
0
Baseline, Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [38]
0
0
Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 20, 24, 28, 32, 36, and 40
Query!
Assessment method [38]
0
0
CHAQ: valid assessment of functional disability, discomfort in participants with rheumatic diseases. It comprises of three indices: Disability and Discomfort, and global assessment of arthritis (overall well-being). CHAQ-DI: as a measure of functional ability, consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on a 4-point scale of difficulty in performance ranges from 0 (no difficulty) to 3 (unable to do). To calculate overall score, participant must have a domain score in at least 6 of the 8 domains. Scores of 8 domains were averaged to calculate the CHAQ-DI total score which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher score indicates more disability. Change from double-blind baseline at Weeks 20, 24, 28, 32, 36, and 40 in DI total score is reported.
Query!
Timepoint [38]
0
0
Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, and 40
Query!
Secondary outcome [39]
0
0
Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18
Query!
Assessment method [39]
0
0
CHQ: 50-item, 14 subscale (Global health, physical functioning, social limitations: emotional, social limitations: physical, bodily pain, behavior, global behavior, mental health, self-esteem, general health, Change in health, emotional impact on parent, time impact on parent, family activities, family cohesion) parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents. Each subscale rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Two summary scores: Physical Health and Psychosocial Health were weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.
Query!
Timepoint [39]
0
0
Baseline, Week 4 and Week 18
Query!
Secondary outcome [40]
0
0
Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44
Query!
Assessment method [40]
0
0
CHQ: 50-item, 14 subscale (Global health, physical functioning, social limitations: emotional, social limitations: physical, bodily pain, behavior, global behavior, mental health, self-esteem, general health, Change in health, emotional impact on parent, time impact on parent, family activities, family cohesion) parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents. Each subscale rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Two summary scores: Physical Health and Psychosocial Health were weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.
Query!
Timepoint [40]
0
0
Double-Blind Baseline (Week 18), Week 44
Query!
Secondary outcome [41]
0
0
Open Label Phase: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 2, 4, 8, 12 and 18
Query!
Assessment method [41]
0
0
CHAQ is a validated instrument and comprises of two indices, Disability and Discomfort, and global assessment of arthritis (overall well-being). Discomfort Index included: assessment of discomfort, the parent/legal guardian/participant were asked to provide a response to the question: How much pain do you think your child had because of his or her illness in the past week?, The parent/legal guardian/ participant rated the overall pain on a 0 to 10 VAS, where '0' indicates 'No Pain' and '10' indicates 'Very Severe Pain', higher scores indicates more severity.
Query!
Timepoint [41]
0
0
Baseline, Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [42]
0
0
Double Blind Phase:Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [42]
0
0
CHAQ is a validated instrument and comprises of two indices, Disability and Discomfort, and global assessment of arthritis (overall well-being). Discomfort Index included: assessment of discomfort, the parent/legal guardian/participant were asked to provide a response to the question: How much pain do you think your child had because of his or her illness in the past week?, The parent/legal guardian/ participant rated the overall pain on a 0 to 10 VAS, where '0' indicates 'No Pain' and '10' indicates 'Very Severe Pain', higher scores indicates more severity.
Query!
Timepoint [42]
0
0
Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36,40 and 44
Query!
Secondary outcome [43]
0
0
Open-Label Phase: Percentage of Participants With Active Uveitis at Baseline
Query!
Assessment method [43]
0
0
Uveitis is the inflammation of the uvea. Participants were assessed for presence of uveitis (according to Standard Uveitis Nomenclature [SUN]). If Uveitis was present in participant at Baseline, it was considered as "active uveitis"; If Uveitis was not present in participant at Baseline, it was considered as "Inactive uveitis". As per SUN, Uveitis is defined as: anterior (in which anterior chamber is primary site of inflammation); intermediate (primary site of inflammation: vitreous); posterior (primary site of inflammation: retina or choroid). Percentage of participants with active uveitis (of any type) are reported.
Query!
Timepoint [43]
0
0
Baseline
Query!
Secondary outcome [44]
0
0
Double Blind Phase: Percentage of Participants With Active Uveitis at Week 24 and Week 44
Query!
Assessment method [44]
0
0
Uveitis is the inflammation of the uvea. Participants were assessed for presence of uveitis (according to Standard Uveitis Nomenclature [SUN]). If Uveitis was present in participant at Baseline, it was considered as "active uveitis"; If Uveitis was not present in participant at Baseline, it was considered as "Inactive uveitis". As per SUN, Uveitis is defined as: anterior (in which anterior chamber is primary site of inflammation); intermediate (primary site of inflammation: vitreous); posterior (primary site of inflammation: retina or choroid). Percentage of participants with active uveitis (of any type) are reported.
Query!
Timepoint [44]
0
0
Week 24 and Week 44
Query!
Secondary outcome [45]
0
0
Open-Label Phase: Change From Baseline in the Tender Entheseal Assessment at Weeks 2, 4, 8, 12 and 18
Query!
Assessment method [45]
0
0
Participants with enthesitis-related arthritis (ERA) undergo Tender entheseal assessment. Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.
Query!
Timepoint [45]
0
0
Baseline, weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [46]
0
0
Double Blind Phase: Change From Double-Blind Baseline in the Tender Entheseal Assessment at Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [46]
0
0
Participants with ERA undergo Tender entheseal assessment. Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.
Query!
Timepoint [46]
0
0
Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [47]
0
0
Open-Label Phase: Change From Baseline in the Modified Schober's Test at Week 2, 4, 8, 12 and 18
Query!
Assessment method [47]
0
0
Participants with ERA undergo Modified Schober's Test. In the Modified Schober's Test, a mark was placed 5 cm below the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 cm above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter and is reported.
Query!
Timepoint [47]
0
0
Baseline, Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [48]
0
0
Double Blind Phase: Change From Double Blind Baseline in the Modified Schober's Test at Week 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [48]
0
0
Participants with ERA undergo Modified Schober's Test. In the Modified Schober's Test, a mark was placed 5 cm below the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 cm above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter and is reported.
Query!
Timepoint [48]
0
0
Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [49]
0
0
Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18
Query!
Assessment method [49]
0
0
Participants with ERA undergo Overall Back Pain and Nocturnal Back Pain assessment. For Overall Back Pain, parent/legal guardian/participant were asked to provide a response to the question: What is the amount of back pain at any time that your child experienced in the past week? And For Nocturnal Back Pain: What is the amount of back pain at night that your child experienced in the past week?. Response to these questions was provided by parent/legal guardian/participant using a VAS of 0-10, where 0= No Pain and 10= Most Severe Pain, higher score indicated more severe pain.
Query!
Timepoint [49]
0
0
Baseline, Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [50]
0
0
Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [50]
0
0
Participants with ERA undergo Overall Back Pain and Nocturnal Back Pain assessment. For Overall Back Pain, parent/legal guardian/participant were asked to provide a response to the question: What is the amount of back pain at any time that your child experienced in the past week? And For Nocturnal Back Pain: What is the amount of back pain at night that your child experienced in the past week?. Response to these questions was provided by parent/legal guardian/participant using a VAS of 0-10, where 0= No Pain and 10= Most Severe Pain, higher score indicated more severe pain.
Query!
Timepoint [50]
0
0
Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [51]
0
0
Open-Label Phase: Changes From Baseline in Percentage of Body Surface Area (BSA) Affected With Psoriasis at Weeks 2, 4, 8, 12 and 18
Query!
Assessment method [51]
0
0
Percentage of body surface area affected by psoriasis was estimated using the palm method. One of the participant's palm to proximal interphalangeal (PIP) and thumb =\together represented 1% of total BSA. Regions of the body were assigned specific number of palms with percentage (Head and Neck = 10% [10 palms], Upper extremities = 20% [20 palms], Trunk [axillae and groin] = 30% [30 palms], Lower extremities [buttocks] = 40% [40 palms]). The number of palms of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
Query!
Timepoint [51]
0
0
Baseline, Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [52]
0
0
Double Blind Phase: Changes From Double Blind Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [52]
0
0
Percentage of body surface area affected by psoriasis was estimated using the palm method. One of the participant's palm to PIP and thumb together represented 1% of total BSA. Regions of the body were assigned specific number of palms with percentage (Head and Neck = 10% [10 palms], Upper extremities = 20% [20 palms], Trunk [axillae and groin] = 30% [30 palms], Lower extremities [buttocks] = 40% [40 palms]). The number of palms of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.
Query!
Timepoint [52]
0
0
Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [53]
0
0
Open-Label Phase: Changes From Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 2, 4, 8, 12 and 18
Query!
Assessment method [53]
0
0
The PGA of psoriasis was scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 5 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and ranged as 0= no symptom to 5=severe, higher score indicates more severity.
Query!
Timepoint [53]
0
0
Baseline, Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [54]
0
0
Double Blind Phase:Change From Double-Blind Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Assessment method [54]
0
0
The PGA of psoriasis was scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 5 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and ranged as 0= no symptom to 5=severe, higher score indicates more severity.
Query!
Timepoint [54]
0
0
Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [55]
0
0
Open-Label Phase: Taste Assessment of Tofacitinib Oral Solution on Day 14
Query!
Assessment method [55]
0
0
Oral solution was given only to participants weighing <40 kg and to the participants who were unable to swallow tablets. Taste assessment was evaluated using a 5 categories questionnaire. Participants were asked to answer in one of the following categories to describe the taste of oral solution of tofacitinib: dislike very much, dislike a little, not sure, like a little and like very much. Number of participants within each category are reported.
Query!
Timepoint [55]
0
0
Day 14
Query!
Secondary outcome [56]
0
0
Open-Label Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases
Query!
Assessment method [56]
0
0
Serious infection defined as any infection that requires hospitalization for treatment or requires parenteral antimicrobial therapy or meets other criteria that require it to be classified as a serious adverse event. Cytopenia was categorized as: lymphocyte counts: <500 lymphocytes/ millimeter^3 (mm), neutrophil counts <1000 neutrophils/mm^3, platelet counts <100,000 platelets/mm^3, any single hemoglobin value <8 grams/decilitre (g/dL) and any single hemoglobin value drops >=2 g/dL below baseline. Number of Participants With serious infections, cytopenia, malignancies and Cardiovascular Diseases are reported.
Query!
Timepoint [56]
0
0
From the first dose of study drug up to Week 18
Query!
Secondary outcome [57]
0
0
Double Blind Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases
Query!
Assessment method [57]
0
0
Serious infection defined as any infection that requires hospitalization for treatment or requires parenteral antimicrobial therapy or meets other criteria that require it to be classified as a serious adverse event. Cytopenia was categorized as: lymphocyte counts <500 lymphocytes/mm^3, neutrophil counts <1000 neutrophils/mm^3, platelet counts <100000 platelets/mm^3, any single hemoglobin (hg) value <8 g/dL and any single hemoglobin value drops >=2 g/dL below baseline. Number of Participants With serious infections, cytopenia, malignancies and Cardiovascular Diseases are reported.
Query!
Timepoint [57]
0
0
From the first dose of study drug in double blind up to week 44
Query!
Secondary outcome [58]
0
0
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair)
Query!
Assessment method [58]
0
0
Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: no hair, Stage 2: downy hair, Stage 3: Scant terminal hair, Stage 4: Terminal hair that fills the entire triangle overlying the pubic region and Stage 5: Terminal hair that extends beyond the inguinal crease onto the thigh. Tanner Stage for pubic hair at Day 1 was summarized and reported using number of participants in each stage.
Query!
Timepoint [58]
0
0
Day 1
Query!
Secondary outcome [59]
0
0
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair)
Query!
Assessment method [59]
0
0
Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males) were assessed in this study and with values in the scale ranging from: Stage 1: no hair, Stage 2: downy hair, Stage 3: Scant terminal hair, Stage 4: Terminal hair that fills the entire triangle overlying the pubic region and Stage 5: Terminal hair that extends beyond the inguinal crease onto the thigh. Tanner Stage for pubic hair at Week 44 was summarized and reported using number of participants in each stage.
Query!
Timepoint [59]
0
0
Week 44
Query!
Secondary outcome [60]
0
0
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam)
Query!
Assessment method [60]
0
0
Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: No glandular breast tissue palpable, Stage 2: Breast bud palpable under areola (1st pubertal sign in females), Stage 3: Breast tissue palpable outside areola; no areolar development, Stage 4: Areola elevated above contour of the breast, forming "double scoop" appearance, Stage 5: Areolar mound recedes back into single breast contour with areolar hyperpigmentation, papillae development and nipple protrusion. Tanner Stage for Breast at Day 1 was summarized and reported using number of participants in each stage.
Query!
Timepoint [60]
0
0
Day 1
Query!
Secondary outcome [61]
0
0
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam)
Query!
Assessment method [61]
0
0
Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: No glandular breast tissue palpable, Stage 2: Breast bud palpable under areola (1st pubertal sign in females), Stage 3: Breast tissue palpable outside areola; no areolar development, Stage 4: Areola elevated above contour of the breast, forming "double scoop" appearance, Stage 5: Areolar mound recedes back into single breast contour with areolar hyperpigmentation, papillae development and nipple protrusion. Tanner Stage for Breast at Week 44 was summarized and reported using number of participants in each stage.
Query!
Timepoint [61]
0
0
Week 44
Query!
Secondary outcome [62]
0
0
Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Genitalia)
Query!
Assessment method [62]
0
0
Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: Testicular volume < 4 ml or long axis < 2.5 cm, Stage 2: 4 ml-8 ml (or 2.5-3.3 cm long), 1st pubertal sign in males, Stage 3: 9 ml-12 ml (or 3.4-4.0 cm long), Stage 4: 15-20 ml (or 4.1-4.5 cm long), Stage 5: > 20 ml (or > 4.5 cm long). Tanner Stage for genitalia at Day 1 was summarized and reported using number of participants in each stage.
Query!
Timepoint [62]
0
0
Day 1
Query!
Secondary outcome [63]
0
0
Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Genitalia)
Query!
Assessment method [63]
0
0
Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: Testicular volume < 4 ml or long axis < 2.5 cm, Stage 2: 4 ml-8 ml (or 2.5-3.3 cm long), 1st pubertal sign in males, Stage 3: 9 ml-12 ml (or 3.4-4.0 cm long), Stage 4: 15-20 ml (or 4.1-4.5 cm long), Stage 5: > 20 ml (or > 4.5 cm long). Tanner Stage for genitalia at Week 44 was summarized and reported using number of participants in each stage.
Query!
Timepoint [63]
0
0
Week 44
Query!
Secondary outcome [64]
0
0
Open-Label Phase: Number of Participants With Laboratory Abnormalities
Query!
Assessment method [64]
0
0
Criteria: Hemoglobin(Hg),hematocrit erythrocytes(Ery); <0.8*lower limit of normal (LLN), Ery. Mean Corpuscular Volume; <0.9*LLN, >1.1*upper limit of normal (ULN), Platelets; <0.5*LLN, >1.75*ULN, Leukocytes (leu); <0.6*LLN, >1.5*ULN, Lymphocytes (Ly), Ly/leu, Neutrophils, Neutrophils/leu <0.8*LLN, Basophils/leu, Eosinophils, Eosinophils/leu, Monocytes, Monocytes/leu >1.2*ULN, Ery Sedimentation Rate >1.5*ULN. Bilirubin, Indirect Bilirubin >1.5*ULN, AST, ALT, Gamma Glutamyl Transferase, Alkaline Phosphatase >3.0*ULN, Albumin >1.2*ULN, Creatinine >1.3*ULN, HDL Cholesterol (Chol)<0.8*LLN, LDL Chol, LDL Chol Friedewald Est PEG >1.2*ULN, Triglycerides >1.3*ULN, Calcium <0.9*LLN, Bicarbonate <0.9*LLN, Glucose >1.5*ULN, Creatine Kinase >2.0*ULN, C Reactive Protein >1.1*ULN, Chol >1.3*ULN. Urinalysis: Specific Gravity >1.030, Glucose, Ketones, Protein, Hg, Nitrite, Leu Esterase >=1, Ery, Leu >=20, Hyaline Casts >1.Only those category in which at least 1 participant had data is reported.
Query!
Timepoint [64]
0
0
From the first dose of study drug up to Week 18
Query!
Secondary outcome [65]
0
0
Double Blind Phase: Number of Participants With Laboratory Abnormalities
Query!
Assessment method [65]
0
0
Criteria: Hg, hematocrit Ery; <0.8* LLN, Ery. Mean Corpuscular Volume; <0.9*LLN, >1.1* ULN, Platelets; <0.5*LLN, >1.75*ULN, leu; <0.6*LLN, >1.5*ULN, Ly, Ly/leu, Neutrophils, Neutrophils/leu <0.8*LLN, Basophils/leu, Eosinophils, Eosinophils/leu, Monocytes, Monocytes/leu >1.2*ULN, Prothrombin Time >1.1*ULN, Ery Sedimentation Rate >1.5*ULN. Bilirubin, Direct Bilirubin, Indirect Bilirubin >1.5*ULN, AST, ALT, Gamma Glutamyl Transferase (GGT), Alkaline Phosphatase >3.0*ULN, Albumin >1.2*ULN, Creatinine >1.3*ULN, HDL Cholesterol (Chol)<0.8*LLN, LDL Chol, LDL Chol Friedewald Est PEG >1.2*ULN, Triglycerides >1.3*ULN, Calcium <0.9*LLN, Bicarbonate <0.9*LLN, Glucose >1.5*ULN, Creatine Kinase >2.0*ULN, C Reactive Protein >1.1*ULN, Chol >1.3*ULN. Urinalysis: Specific Gravity >1.030, pH >8, urine Glucose, Ketones, Protein, Hg, Nitrite, Leu Esterase >=1, Ery, Leu >=20, Hyaline Casts >1.Only those category in which at least 1 participant had data is reported.
Query!
Timepoint [65]
0
0
From the first dose of study drug in double blind up to Week 44
Query!
Secondary outcome [66]
0
0
Open-Label Phase: Number of Participants With Physical Examination Abnormalities
Query!
Assessment method [66]
0
0
Physical examination included: abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, lymph nodes, neurological, nose, skin, and throat. Abnormality in physical examination was based on investigator's discretion.
Query!
Timepoint [66]
0
0
Baseline, Weeks 2, 4, 8, 12 and 18
Query!
Secondary outcome [67]
0
0
Double Blind Phase: Number of Participants With Physical Examination Abnormalities
Query!
Assessment method [67]
0
0
Physical examination included: abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, lymph nodes, neurological, nose, skin, and throat. Abnormality in physical examination was based on investigator's discretion.
Query!
Timepoint [67]
0
0
Weeks 18, 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [68]
0
0
Open-Label Phase: Number of Participants With Vital Sign Abnormalities
Query!
Assessment method [68]
0
0
Vital Sign Abnormalities criteria included: sitting diastolic blood pressure millimeters of Mercury (mmHG) of <50 mmHg, sitting pulse rate beats per minute (bpm) of <40 or 120 bpm, sitting systolic blood pressure (mmHG) of <90 mmHg, supine diastolic blood pressure (mmHG) of <50 mmHg, supine pulse rate (BPM) of <40 bpm or >120 bpm, supine systolic blood pressure (mmHG) of 90 mmHg.
Query!
Timepoint [68]
0
0
From the first dose of study drug up to Week 18
Query!
Secondary outcome [69]
0
0
Double Blind Phase: Number of Participants With Vital Sign Abnormalities
Query!
Assessment method [69]
0
0
Vital Sign Abnormalities criteria included: diastolic blood pressure (mmHG) of <50 mmHg, Pulse rate (BPM) of <40 bpm or >120 bpm, sitting diastolic blood pressure (mmHG) of <50 mmHg, sitting pulse rate beats per minute (bpm) of <40 bpm or >120 bpm, sitting systolic blood pressure (mmHG) of <90 mmHg, supine diastolic blood pressure (mmHG) of <50 mmHg, supine pulse rate (BPM) of <40 bpm or >120 bpm, supine systolic blood pressure (mmHG) of <90 mmHg, systolic blood pressure (mmHG) of <90 mmHg.
Query!
Timepoint [69]
0
0
From the first dose of study drug in double blind up to week 44
Query!
Secondary outcome [70]
0
0
Open-Label Phase: Number of Participants With Change From Baseline in Vital Sign Measures
Query!
Assessment method [70]
0
0
Change in vital Signs included: Sitting diastolic blood pressure [mmHG]: >=20mmHg increase from baseline (IFB) and >= 20mmHg decrease from baseline (DFB). Sitting systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB. Supine diastolic blood pressure mmHG: >= 20mmHg IFB and >= 20mmHg DFB. Supine systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB.
Query!
Timepoint [70]
0
0
From the first dose of study drug up to Week 18
Query!
Secondary outcome [71]
0
0
Double Blind Phase: Number of Participants With Change From Baseline in Vital Sign Measures
Query!
Assessment method [71]
0
0
Change in vital Signs included: Sitting diastolic blood pressure (mmHG): >=20mmHg IFB and >= 20mmHg DFB. Sitting systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB. Supine diastolic blood pressure mmHG: >= 20mmHg IFB and >= 20mmHg DFB. Supine systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB.
Query!
Timepoint [71]
0
0
From the first dose of study drug in double blind up to week 44
Query!
Eligibility
Key inclusion criteria
1. Male or female aged 2 to <18 years.
2. Must meet International League Against Rheumatism (ILAR) JIA diagnostic criteria for
one of the following categories with active disease for at least 6 weeks:
- Extended oligoarthritis;
- Polyarthritis (RF+);
- Polyarthritis (RF-);
- Systemic JIA with active arthritis but without active systemic features in the
prior 6 months and at the time of enrollment;
- Psoriatic arthritis;
- Enthesitis related arthritis. Subjects with polyarticular course JIA (ie,
extended oligoarthritis, polyarthritis RF+, polyarthritis RF , systemic JIA with
active arthritis but without active systemic features) must have a minimum of 5
active joints (an active joint is defined as a joint with swelling or, in the
absence of swelling, limited range of motion accompanied by either pain on motion
or tenderness) at screening and baseline to be eligible for study entry.
Subjects with psoriatic or enthesitis related arthritis must have a minimum of 3
active joints (an active joint is defined as a joint with swelling or, in the absence
of swelling, limited range of motion accompanied by either pain on motion or
tenderness) at screening and baseline to be eligible for study entry.
Treatment with stable doses of a Non Steroidal Anti inflammatory Drug (NSAID) and/or a
stable dose of an oral glucocorticoid, and/or a stable dose of methotrexate is
permitted.
For subjects receiving an oral glucocorticoid: Glucocorticoids may be administered at
a maximum dose of 0.2 mg of prednisone equivalent per kilogram per day or 10 mg per
day for = 2 weeks before baseline, whichever is lower.
For subjects receiving methotrexate (MTX) treatment: MTX may be administered either
orally or parenterally at doses not to exceed 25 mg/wk or 20 mg/m2/week (whichever is
lower); participants must have taken MTX for 3 months and be at a stable dose for at
least 6 weeks before baseline. Subjects taking MTX must be taking folic acid or
folinic acid in accordance with local standards.
For subjects with psoriatic arthritis, the following topical treatments for psoriasis
are allowed: non medicated emollients for use over the whole body; topical steroids
including hydrocortisone and hydrocortisone acetate =1% for the palms, soles, face,
and intertriginous areas only; tar, salicylic acid preparations, and shampoos free of
corticosteroids are permitted only for the scalp
3. Inadequate response or intolerance to at least one Disease Modifying Anti Rheumatic
Drug (DMARD), which may include MTX or biologic agents; in the case of ERA and
psoriatic arthritis, inadequate response to Non Steroidal Anti Inflammatory Drugs
(NSAIDs).
4. No evidence or history of untreated or inadequately treated active or latent
tuberculosis (TB) infection as evidenced by the following:
1. A negative QuantiFERON ®TB Gold In Tube test performed within the 3 months prior
to screening. A negative purified protein derivative (PPD) test can be
substituted for the QuantiFERON® TB Gold In Tube test only if the central
laboratory is unable to perform the test or cannot determine the results to be
positive or negative and the Pfizer medical monitor is informed and agrees on a
case by case basis.
2. Chest radiograph without changes suggestive of active tuberculosis (TB) infection
within 3 months prior to screening is recommended and should be performed
according to local standards of care or country-specific guidelines.
3. No history of either untreated or inadequately treated latent or active TB
infection.
If a subject has previously received an adequate course of therapy for either latent
(9 months of isoniazid in a locale where rates of primary multi drug resistant TB
infection are <5% or an acceptable alternative regimen) or active (acceptable multi
drug regimen) TB infection, neither a PPD test nor a QuantiFERON-Gold®TM test need be
obtained. A chest radiograph should be obtained if not done within the 3 months prior
to screening. To be considered eligible for the study, the chest radiograph must be
negative for active tuberculosis infection.
A subject who is currently being treated for latent TB infection can only be enrolled
with confirmation of current incidence rates of multi-drug resistant TB infection,
documentation of an adequate treatment regimen, and prior approval of the Sponsor.
5. Fertile males and females who are, in the opinion of the investigator, sexually active
and at risk for pregnancy with their partner(s) must be willing and able to use a
highly effective method of contraception as outlined in this protocol during the study
and for at least 28 days after the last dose of study medication.
6 Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
7. Evidence of a personally signed and dated Informed Consent document and Assent document
(as appropriate) indicating that the subject and a legally acceptable
representative/parent(s)/legal guardian has been informed of all pertinent aspects of the
study.
Query!
Minimum age
2
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion Criteria
Subjects with any of the following characteristics/conditions will not be included in the
study:
1. Previous JIA treatment with tofacitinib.
2. Systemic JIA (sJIA) with active systemic features (including subjects with
characteristic sJIA fever and rash or serositis within 6 months of enrollment).
3. Persistent oligoarthritis.
4. Undifferentiated JIA.
5. Infections:
1. Chronic infections;
2. Any infection requiring hospitalization, parenteral antimicrobial therapy or
judged to be opportunistic by the investigator within the 6 months prior to the
first dose of study drug;
3. Any treated infections within 2 weeks of Baseline visit;
4. A subject know to be infected with Human Immunodeficiency Virus (HIV), Hepatitis
B, or Hepatitis C;
5. History of infected joint prosthesis with prosthesis still in situ.
6. History of recurrent (more than one episode) herpes zoster or disseminated (at least
one episode) herpes zoster, or disseminated (at least one episode) herpes simplex.
7. Active uveitis (according to SUN criteria) within 3 months of enrollment.
8. Blood dyscrasias, including:
1. Hemoglobin <10 g/dL or Hematocrit <33%;
2. White Blood Cell count <3.0 x 109/L;
3. Neutrophil count <1.2 x 109/L;
4. Platelet count <100 x 109/L;
5. Lymphocyte count <0.75 x 109/L.
9. Estimated glomerular filtration rate [GFR] <40 mL/min/1.73 m2 at Screening. GFR will
be calculated by the central lab using the bedside Schwartz formula.
10. Current or recent history of uncontrolled clinically significant renal, hepatic,
hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic
disease.
11. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =1.5 times the
upper limit of normal.
12. History of any other rheumatologic disease, other than Sjogren's syndrome..
13. History or current symptoms suggestive of lymphoproliferative disorders (eg, Epstein
Barr Virus [EBV] related lymphoproliferative disorder, lymphoma, leukemia, or signs
and symptoms of current lymphatic disease).
14. Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the
first dose of study drug, or is expected to be vaccinated or to have household
exposure to these vaccines during treatment or during the 6 weeks following
discontinuation of study drug.
15. Subjects without documented evidence of having received at least one dose of the
varicella vaccine in countries where the vaccine is approved and standard of care or
those who do not have evidence of prior exposure to varicella zoster virus (VZV) based
on serological testing (ie, VZV IgG Ab).
16. Current malignancy or history of any malignancy with the exception of adequate treated
or excised basal cell or squamous cell or cervical cancer in situ.
17. Subjects who have previously failed more than 3 biologic therapies (with different
mechanisms of action) for JIA.
18. Subjects with a first degree relative with a hereditary immunodeficiency; IgA
deficiency not exclusionary.
19. Recent (within 28 days prior to first dose of study drug) significant trauma or major
surgery.
20. Subjects receiving potent and moderate CYP3A4 inhibitors or inducers.
21. Prior treatment with non B cell specific lymphocyte depleting agents/therapies (eg,
almetuzumab [CAMPATH], alkylating agents [eg, cyclophosphamide or chlorambucil], total
lymphoid irradiation, etc.). Subjects who have received rituximab or other selective B
lymphocyte depleting agents (including experimental agents) are eligible if they have
not received such therapy for at least 1 year prior to study baseline and have normal
CD 19/20+ counts by FACS analysis.
22. Use of prohibited prescription or non prescription drugs and dietary supplements
listed in Appendix 1 and Appendix 4 within the specified time frame prior to the first
dose of study medication.
23. Herbal supplements must be discontinued at least 28 days prior to the first dose of
study medication.
24. Use of certain biologic and non biologic DMARDs are disallowed at any time during this
study (Appendix 1).
25. For subjects with PsA, oral and topical medications and alternative treatments that
could affect psoriasis are prohibited (see Inclusion Criterion 2 for exceptions). This
includes topical corticosteroids, tars, keratolytics, anthralin, vitamin D analogs,
and retinoids which must be discontinued at least 2 weeks prior to first dose of study
drug. Also prohibited is ultraviolet B (UVB) (narrowband or broadband) phototherapy
that must be discontinued at least 2 weeks prior to first dose of study drug.
Psoralens + ultraviolet A (UVA) phototherapy (PUVA) must be discontinued at least 4
weeks prior to first dose of study drug.
26. Subjects who are children of or related to investigational site staff members, site
staff members otherwise supervised by the investigator, or Pfizer employees directly
involved in the conduct of the study.
27. Participation in other studies involving investigational drug(s) within 4 weeks or 5
half lives (whichever is longer) prior to study entry and/or during study
participation. Exposure to investigational biologics should be discussed with the
Sponsor.
28. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
29. Pregnant or nursing females are excluded.
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
10/06/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
16/05/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
225
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
The Sydney Children's Hospital Network Westmead - Westmead
Query!
Recruitment hospital [2]
0
0
The Royal Children's Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [2]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
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
Georgia
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
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Minnesota
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New Jersey
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
North Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Ohio
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Oregon
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Pennsylvania
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Texas
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Utah
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Washington
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
Santa FE
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Tucuman
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Caba
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Leuven
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Bahia
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
MG
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Minas Gerais
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Parana
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
RJ
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
SAO Paulo
Query!
Country [30]
0
0
Brazil
Query!
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Sao Paulo
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Canada
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Quebec
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Jalisco
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Mexico
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San Luis Potosi
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Poland
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Bydgoszcz
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Tolyatti
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Spain
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Madrid
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Spain
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Valencia
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Turkey
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Istanbul
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Turkey
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Kayseri
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Vinnytsia
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United Kingdom
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Hampshire
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United Kingdom
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WEST Midlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Summary
Brief summary
Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02592434
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Contacts
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Pfizer CT.gov Call Center
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Pfizer
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02592434
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