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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00962741
Registration number
NCT00962741
Ethics application status
Date submitted
13/08/2009
Date registered
20/08/2009
Date last updated
10/06/2014
Titles & IDs
Public title
Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
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Scientific title
A 2-Part Open-Label Study to Assess the Clinical Benefit and Long-Term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis
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Secondary ID [1]
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B1801014
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Secondary ID [2]
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0881A1-3338
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Universal Trial Number (UTN)
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Trial acronym
CLIPPER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis, Juvenile Idiopathic
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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 - Etanercept
Experimental: 1 - Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Treatment: Drugs: Etanercept
Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12
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Assessment method [1]
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ACR Pedi 30 response: greater than or equal to (\>=) 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Percentage of Participants With an ACR Pedi 30 Response
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Assessment method [1]
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ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
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Timepoint [1]
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Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [2]
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Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population
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Assessment method [2]
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ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
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Timepoint [2]
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Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [3]
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Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
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Assessment method [3]
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ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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Timepoint [3]
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Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [4]
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Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
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Assessment method [4]
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ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
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Timepoint [4]
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0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [5]
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Percentage of Participants With an ACR Pedi 50 Response
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Assessment method [5]
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ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [5]
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0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [6]
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Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
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Assessment method [6]
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ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [6]
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0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [7]
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Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
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Assessment method [7]
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ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [7]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [8]
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Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
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Assessment method [8]
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ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [8]
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0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [9]
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Percentage of Participants With an ACR Pedi 70 Response
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Assessment method [9]
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ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [9]
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0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [10]
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Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
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Assessment method [10]
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ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [10]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [11]
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Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
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Assessment method [11]
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ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [11]
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0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [12]
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Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
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Assessment method [12]
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ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [12]
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0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [13]
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Percentage of Participants With an ACR Pedi 90 Response
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Assessment method [13]
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ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [13]
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0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [14]
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Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
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Assessment method [14]
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ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [14]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [15]
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0
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
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Assessment method [15]
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0
ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [15]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [16]
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Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
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Assessment method [16]
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ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [16]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [17]
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Percentage of Participants With an ACR Pedi 100 Response
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Assessment method [17]
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ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [17]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [18]
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Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
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Assessment method [18]
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ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [18]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [19]
0
0
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
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Assessment method [19]
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ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [19]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [20]
0
0
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
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Assessment method [20]
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0
ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
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Timepoint [20]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [21]
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0
Physician's Global Assessment (PGA) of Disease Activity
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Assessment method [21]
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PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
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Timepoint [21]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [22]
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0
Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population
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Assessment method [22]
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0
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
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Timepoint [22]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [23]
0
0
Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population
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Assessment method [23]
0
0
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
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Timepoint [23]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [24]
0
0
Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population
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Assessment method [24]
0
0
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
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Timepoint [24]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [25]
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0
Patient/Parent Global Assessment
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Assessment method [25]
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0
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
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Timepoint [25]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [26]
0
0
Patient/Parent Global Assessment: eoJIA Sub-population
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Assessment method [26]
0
0
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
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Timepoint [26]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [27]
0
0
Patient/Parent Global Assessment: ERA Sub-population
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Assessment method [27]
0
0
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
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Timepoint [27]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [28]
0
0
Patient/Parent Global Assessment: PsA Sub-population
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Assessment method [28]
0
0
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
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Timepoint [28]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [29]
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0
Number of Active Joints
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Assessment method [29]
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0
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
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Timepoint [29]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [30]
0
0
Number of Active Joints: eoJIA Sub-population
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Assessment method [30]
0
0
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
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Timepoint [30]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [31]
0
0
Number of Active Joints: ERA Sub-population
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Assessment method [31]
0
0
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
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Timepoint [31]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [32]
0
0
Number of Active Joints: PsA Sub-population
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Assessment method [32]
0
0
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
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Timepoint [32]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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Secondary outcome [33]
0
0
Number of Joints With Limitation of Motion
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Assessment method [33]
0
0
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Query!
Timepoint [33]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [34]
0
0
Number of Joints With Limitation of Motion: eoJIA Sub-population
Query!
Assessment method [34]
0
0
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Query!
Timepoint [34]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [35]
0
0
Number of Joints With Limitation of Motion: ERA Sub-population
Query!
Assessment method [35]
0
0
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Query!
Timepoint [35]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [36]
0
0
Number of Joints With Limitation of Motion: PsA Sub-population
Query!
Assessment method [36]
0
0
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Query!
Timepoint [36]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [37]
0
0
C-reactive Protein (CRP)
Query!
Assessment method [37]
0
0
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Query!
Timepoint [37]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [38]
0
0
C-reactive Protein (CRP): eoJIA Sub-population
Query!
Assessment method [38]
0
0
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Query!
Timepoint [38]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [39]
0
0
C-reactive Protein (CRP): ERA Sub-population
Query!
Assessment method [39]
0
0
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Query!
Timepoint [39]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [40]
0
0
C-reactive Protein (CRP): PsA Sub-population
Query!
Assessment method [40]
0
0
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Query!
Timepoint [40]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [41]
0
0
Pain Assessment
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Assessment method [41]
0
0
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Query!
Timepoint [41]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [42]
0
0
Pain Assessment: eoJIA Sub-population
Query!
Assessment method [42]
0
0
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Query!
Timepoint [42]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [43]
0
0
Pain Assessment: ERA Sub-population
Query!
Assessment method [43]
0
0
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Query!
Timepoint [43]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [44]
0
0
Pain Assessment: PsA Sub-population
Query!
Assessment method [44]
0
0
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Query!
Timepoint [44]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [45]
0
0
Duration of Morning Stiffness
Query!
Assessment method [45]
0
0
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Query!
Timepoint [45]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [46]
0
0
Duration of Morning Stiffness: eoJIA Sub-population
Query!
Assessment method [46]
0
0
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Query!
Timepoint [46]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [47]
0
0
Duration of Morning Stiffness: ERA Sub-population
Query!
Assessment method [47]
0
0
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Query!
Timepoint [47]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [48]
0
0
Duration of Morning Stiffness: PsA Sub-population
Query!
Assessment method [48]
0
0
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Query!
Timepoint [48]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [49]
0
0
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Query!
Assessment method [49]
0
0
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Query!
Timepoint [49]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [50]
0
0
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Query!
Assessment method [50]
0
0
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Query!
Timepoint [50]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [51]
0
0
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Query!
Assessment method [51]
0
0
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Query!
Timepoint [51]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [52]
0
0
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Query!
Assessment method [52]
0
0
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Query!
Timepoint [52]
0
0
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [53]
0
0
Childhood Health Assessment Questionnaire (CHAQ) Score
Query!
Assessment method [53]
0
0
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Query!
Timepoint [53]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [54]
0
0
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
Query!
Assessment method [54]
0
0
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Query!
Timepoint [54]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [55]
0
0
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
Query!
Assessment method [55]
0
0
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Query!
Timepoint [55]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Secondary outcome [56]
0
0
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Query!
Assessment method [56]
0
0
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Query!
Timepoint [56]
0
0
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Query!
Eligibility
Key inclusion criteria
* Male and female subjects with a diagnosis per International League of Associations for Rheumatology (ILAR) criteria of extended oligoarticular juvenile idiopathic arthritis (JIA) between the ages of 2 and 17 years; enthesitis-related arthritis (ERA) between the ages of 12 and 17 years; or psoriatic arthritis (PsA) between the ages of 12 and 17 years.
* >= 2 active joints and the following for the relevant JIA subtype: extended oligoarticular JIA or PsA with a history of intolerance or an unsatisfactory response to a disease modifying antirheumatic drug (DMARD); or ERA with a history of intolerance or an unsatisfactory response to a nonsteroidal anti-inflammatory drug (NSAID) or a DMARD.
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
* Systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated arthritis per ILAR criteria.
* Other rheumatic diseases.
* Active uveitis within 6 months of the baseline visit.
* Any other significant health problem.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
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Type of endpoint/s
Query!
Statistical methods / analysis
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Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/01/2013
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Sample size
Target
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Accrual to date
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Final
127
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
0
0
Pfizer Investigational Site - Westmead, Sydney
Query!
Recruitment hospital [2]
0
0
Pfizer Investigational Site - Parkville, Melbourne
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Recruitment postcode(s) [1]
0
0
2145 - Westmead, Sydney
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Recruitment postcode(s) [2]
0
0
3052 - Parkville, Melbourne
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Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Brussels
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Country [2]
0
0
Belgium
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State/province [2]
0
0
Gent
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Country [3]
0
0
Belgium
Query!
State/province [3]
0
0
Leuven
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Country [4]
0
0
Colombia
Query!
State/province [4]
0
0
Atlantico
Query!
Country [5]
0
0
Colombia
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State/province [5]
0
0
Cundinamarca
Query!
Country [6]
0
0
Colombia
Query!
State/province [6]
0
0
Santander
Query!
Country [7]
0
0
Czech Republic
Query!
State/province [7]
0
0
Brno
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Country [8]
0
0
Czech Republic
Query!
State/province [8]
0
0
Praha 2
Query!
Country [9]
0
0
France
Query!
State/province [9]
0
0
Le Kremlin Bicetre
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Country [10]
0
0
France
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State/province [10]
0
0
Paris Cedex 14
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Country [11]
0
0
France
Query!
State/province [11]
0
0
Paris
Query!
Country [12]
0
0
Germany
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State/province [12]
0
0
Berlin
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Country [13]
0
0
Germany
Query!
State/province [13]
0
0
Bremen
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Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Hamburg
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Country [15]
0
0
Germany
Query!
State/province [15]
0
0
Hannover
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
St. Augustin
Query!
Country [17]
0
0
Hungary
Query!
State/province [17]
0
0
Budapest
Query!
Country [18]
0
0
Italy
Query!
State/province [18]
0
0
Chieti
Query!
Country [19]
0
0
Latvia
Query!
State/province [19]
0
0
Riga
Query!
Country [20]
0
0
Lithuania
Query!
State/province [20]
0
0
Vilnius
Query!
Country [21]
0
0
Mexico
Query!
State/province [21]
0
0
Mexico City
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Country [22]
0
0
Netherlands
Query!
State/province [22]
0
0
Utrecht
Query!
Country [23]
0
0
Norway
Query!
State/province [23]
0
0
Oslo
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Country [24]
0
0
Poland
Query!
State/province [24]
0
0
Bydgoszcz
Query!
Country [25]
0
0
Poland
Query!
State/province [25]
0
0
Krakow
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Country [26]
0
0
Poland
Query!
State/province [26]
0
0
Warszawa
Query!
Country [27]
0
0
Poland
Query!
State/province [27]
0
0
Wroclaw
Query!
Country [28]
0
0
Russian Federation
Query!
State/province [28]
0
0
Moscow
Query!
Country [29]
0
0
Russian Federation
Query!
State/province [29]
0
0
Saint-Petersburg
Query!
Country [30]
0
0
Serbia
Query!
State/province [30]
0
0
Belgrade
Query!
Country [31]
0
0
Serbia
Query!
State/province [31]
0
0
Nis
Query!
Country [32]
0
0
Slovakia
Query!
State/province [32]
0
0
Kosice
Query!
Country [33]
0
0
Slovakia
Query!
State/province [33]
0
0
Piestany
Query!
Country [34]
0
0
Slovenia
Query!
State/province [34]
0
0
Ljubljana
Query!
Country [35]
0
0
Spain
Query!
State/province [35]
0
0
Barcelona
Query!
Country [36]
0
0
Spain
Query!
State/province [36]
0
0
Madrid
Query!
Country [37]
0
0
Spain
Query!
State/province [37]
0
0
Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
Query!
Country
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Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00962741
Query!
Trial related presentations / publications
Foeldvari I, Constantin T, Vojinovic J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Susic G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dolezalova P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00962741
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