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Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis (CLIPPER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00962741
First received: August 13, 2009
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Arthritis, Juvenile Idiopathic
 Drug: Etanercept
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Drug Information available for: Etanercept
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Inactive Disease [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Inactive Disease: 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 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Inactive Disease: 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 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Inactive Disease: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Tender Entheseal Assessment for 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 ] [ Designated as safety issue: No ]
    Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.

  • Overall Back Pain Score for 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 ] [ Designated as safety issue: No ]
    Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain.

  • Nocturnal Back Pain Score for 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 ] [ Designated as safety issue: No ]
    Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain.

  • Modified Schober's Test for 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 ] [ Designated as safety issue: No ]
    Modified Schober's Test: A mark was placed in the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 centimeter (cm) above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter.

  • Percentage of Body Surface Area (BSA) Affected by Psoriasis for 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 ] [ Designated as safety issue: No ]
    Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1 percent (%) of BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck= 10% (10 palms), upper extremities= 20% (20 palms), Trunk (axillae and groin)= 30% (30 palms), lower extremities (buttocks)= 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.

  • Physician's Global Assessment (PGA) of Psoriasis for 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 ] [ Designated as safety issue: No ]
    PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5. 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1.

  • Number of Participants With Adverse Events (AEs) [ Time Frame: Week 12, Week 96 ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.

  • Number of Participants With Adverse Events (AEs): eoJIA Subpopulation [ Time Frame: Week 12, Week 96 ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.

  • Number of Participants With Adverse Events (AEs): ERA Sub-population [ Time Frame: Week 12, Week 96 ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.

  • Number of Participants With Adverse Events (AEs): PsA Sub-population [ Time Frame: Week 12, Week 96 ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.

  • Tanner Assessment Score by Age Group [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]
    Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).

  • Tanner Assessment Score by Age Group for 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 ] [ Designated as safety issue: Yes ]
    Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).

  • Tanner Assessment Score by Age Group for 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 ] [ Designated as safety issue: Yes ]
    Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).

  • Tanner Assessment Score by Age Group for 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 ] [ Designated as safety issue: Yes ]
    Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).

  • Height z-Score by Age Group [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]
    Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Height z-Score by Age Group for 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 ] [ Designated as safety issue: Yes ]
    Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Height z-Score by Age Group for 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 ] [ Designated as safety issue: Yes ]
    Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Height z-Score by Age Group for 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 ] [ Designated as safety issue: Yes ]
    Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Weight z-Scores by Age Group [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]
    Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Weight z-Scores by Age Group for 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 ] [ Designated as safety issue: Yes ]
    Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Weight z-Scores by Age Group for 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 ] [ Designated as safety issue: Yes ]
    Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Weight z-Scores by Age Group for 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 ] [ Designated as safety issue: Yes ]
    Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Body Mass Index (BMI) z-Score by Age Group [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]
    BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]
    BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]
    BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]
    BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

  • Number of Participants With Anti-etanercept Antibodies [ Time Frame: Baseline up to Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population [ Time Frame: Baseline up to Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Anti-etanercept Antibodies: ERA Sub-population [ Time Frame: Baseline up to Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Anti-etanercept Antibodies: PsA Sub-population [ Time Frame: Baseline up to Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Neutralizing Anti-etanercept Antibodies [ Time Frame: Baseline up to Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 ] [ Designated as safety issue: Yes ]

Enrollment: 127
Study Start Date: September 2009
Study Completion Date: January 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
 Drug: Etanercept
Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Other Name: Enbrel

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962741

  Show 42 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00962741     History of Changes
Other Study ID Numbers: 0881A1-3338, B1801014
Study First Received: August 13, 2009
Results First Received: June 14, 2012
Last Updated: February 6, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Depart

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013