Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

Phase 3

Completed

Conditions: Arthritis, Juvenile Idiopathic

Interventions: Drug: Etanercept

Registration Number: NCT00962741

Lead Sponsor: Pfizer

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 127

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.

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Etanercept	Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12	Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With an ACR Pedi 30 Response	Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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).
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 50 Response	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 90 Response	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 70 Response	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 100 Response	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Physician's Global Assessment (PGA) of Disease Activity	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Patient/Parent Global Assessment	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Patient/Parent Global Assessment: eoJIA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Patient/Parent Global Assessment: ERA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Patient/Parent Global Assessment: PsA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Number of Active Joints	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Number of Active Joints: eoJIA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Number of Active Joints: ERA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Number of Active Joints: PsA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Number of Joints With Limitation of Motion	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Number of Joints With Limitation of Motion: eoJIA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Number of Joints With Limitation of Motion: ERA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Number of Joints With Limitation of Motion: PsA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
C-reactive Protein (CRP)	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
C-reactive Protein (CRP): eoJIA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
C-reactive Protein (CRP): ERA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
C-reactive Protein (CRP): PsA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Pain Assessment	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Pain Assessment: eoJIA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Pain Assessment: ERA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Pain Assessment: PsA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Duration of Morning Stiffness	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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).
Duration of Morning Stiffness: eoJIA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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).
Duration of Morning Stiffness: ERA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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).
Duration of Morning Stiffness: PsA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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).
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population	Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Childhood Health Assessment Questionnaire (CHAQ) Score	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96	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.