Trial · NCT02592434
Registered outcomes72
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 72
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Week 44 | 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). |
| Secondary | Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Week 44 | Week 44 | 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. |
| Secondary | Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Week 44 | Week 44 | 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. |
| Secondary | Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Week 44 | Week 44 | 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. |
| Secondary | 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 | Baseline, Week 44 | 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. |
| Secondary | 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 | Weeks 2, 4, 8, 12 and 18 | 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. |
| Secondary | 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 | Weeks 20, 24, 28, 32, 36 and 40 | 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. |
| Secondary | Open-Label Phase: Time to Disease Flare | Day 1 up to week 18 | 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. |
| Secondary | Double Blind Phase: Time to Disease Flare | Day 1 of Week 19 up to week 44 | 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. |
| Secondary | 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 | Weeks 2, 4, 8, 12 and 18 | 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. |
| Secondary | 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 | Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40 | 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. |
| Secondary | 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 | Weeks 2, 4, 8, 12 and 18 | 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. |
| Secondary | 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 | Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40 | 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. |
| Secondary | 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 | Weeks 2, 4, 8, 12 and 18 | 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. |
| Secondary | 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 | Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40 | 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. |
| Secondary | 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 | Weeks 2, 4, 8, 12 and 18 | 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. |
| Secondary | 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 | Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44 | 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. |
| Secondary | 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 | Weeks 2, 4, 8, 12 and 18 | 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. |
| Secondary | 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 | Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44 | 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. |
| Secondary | 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 | Baseline, Weeks 2, 4, 8, 12 and 18 | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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