Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2011

Interventions

  • Drug: Etanercept
    • Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg

Arms, Groups and Cohorts

  • Experimental: 1
    • Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12
    • Time Frame: 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 Measures

  • Percentage of Participants With an ACR Pedi 30 Response
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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: PsA Sub-population
    • Time Frame: 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
    • Time Frame: 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: eoJIA Sub-population
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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: PsA Sub-population
    • Time Frame: 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 100 Response
    • Time Frame: 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: eoJIA Sub-population
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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: eoJIA Sub-population
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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