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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Juvenile Idiopathic
• Intervention / Treatment: Drug: Etanercept

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, Sydney, New South Wales, Australia, 2145
      • Pfizer Investigational Site
  • Victoria
    • Parkville, Melbourne, Victoria, Australia, 3052
      • Pfizer Investigational Site
• Belgium
  • Brussels, Belgium, 1200
    • Pfizer Investigational Site
  • Gent, Belgium, 9000
    • Pfizer Investigational Site
  • Leuven, Belgium, 3000
    • Pfizer Investigational Site
• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia
      • Pfizer Investigational Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 0000
      • Pfizer Investigational Site
  • Santander
    • Bucaramanga, Santander, Colombia
      • Pfizer Investigational Site
• Czech Republic
  • Brno, Czech Republic, 625 00
    • Pfizer Investigational Site
  • Praha 2, Czech Republic, 128 50
    • Pfizer Investigational Site
  • Praha 2, Czech Republic, 121 00
    • Pfizer Investigational Site
• France
  • Le Kremlin Bicetre, France, 92470
    • Pfizer Investigational Site
  • Paris, France, 75015
    • Pfizer Investigational Site
  • Paris Cedex 14, France, 75674
    • Pfizer Investigational Site
• Germany
  • Berlin, Germany, 13125
    • Pfizer Investigational Site
  • Bremen, Germany, 28177
    • Pfizer Investigational Site
  • Hamburg, Germany, 22081
    • Pfizer Investigational Site
  • Hannover, Germany, 30625
    • Pfizer Investigational Site
  • St. Augustin, Germany, 53757
    • Pfizer Investigational Site
• Hungary
  • Budapest, Hungary, 1094
    • Pfizer Investigational Site
• Italy
  • Chieti, Italy, 66013
    • Pfizer Investigational Site
• Latvia
  • Riga, Latvia, 1079
    • Pfizer Investigational Site
  • Riga, Latvia, LV1004
    • Pfizer Investigational Site
• Lithuania
  • Vilnius, Lithuania, LT 2600
    • Pfizer Investigational Site
• Mexico
  • Mexico City, Mexico, 06700
    • Pfizer Investigational Site
• Netherlands
  • Utrecht, Netherlands, 3584 EA
    • Pfizer Investigational Site
• Norway
  • Oslo, Norway, 0027
    • Pfizer Investigational Site
• Poland
  • Bydgoszcz, Poland, 85-667
    • Pfizer Investigational Site
  • Krakow, Poland, 31-503
    • Pfizer Investigational Site
  • Warszawa, Poland, 02-673
    • Pfizer Investigational Site
  • Wroclaw, Poland, 52-114
    • Pfizer Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 115522
    • Pfizer Investigational Site
  • Saint-Petersburg, Russian Federation, 194100
    • Pfizer Investigational Site
• Serbia
  • Belgrade, Serbia, 11000
    • Pfizer Investigational Site
  • Nis, Serbia, 18000
    • Pfizer Investigational Site
• Slovakia
  • Kosice, Slovakia, 040 01
    • Pfizer Investigational Site
  • Piestany, Slovakia, 921 12
    • Pfizer Investigational Site
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Pfizer Investigational Site
• Spain
  • Madrid, Spain, 28034
    • Pfizer Investigational Site
  • Madrid, Spain, 28046
    • Pfizer Investigational Site
  • Valencia, Spain, 46026
    • Pfizer Investigational Site
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at 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.	Week 12

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tender Entheseal Assessment for ERA Sub-population	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.	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Overall Back Pain Score for ERA Sub-population	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.	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Nocturnal Back Pain Score for ERA Sub-population	Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain.	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Modified Schober's Test for ERA Sub-population	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.	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population	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.	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population	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.	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Number of Participants With Adverse Events (AEs)	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.	Week 12, Week 96
Number of Participants With Adverse Events (AEs): eoJIA Subpopulation	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.	Week 12, Week 96
Number of Participants With Adverse Events (AEs): ERA Sub-population	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.	Week 12, Week 96
Number of Participants With Adverse Events (AEs): PsA Sub-population	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.	Week 12, Week 96
Tanner Assessment Score by Age Group	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).	Baseline, Week 12, Week 48, Week 96
Tanner Assessment Score by Age Group for eoJIA Sub-population	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).	Baseline, Week 12, Week 48, Week 96
Tanner Assessment Score by Age Group for ERA Sub-population	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).	Baseline, Week 12, Week 48, Week 96
Tanner Assessment Score by Age Group for PsA Sub-population	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).	Baseline, Week 12, Week 48, Week 96
Height z-Score by Age Group	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.	Baseline, Week 12, Week 48, Week 72, Week 96
Height z-Score by Age Group for eoJIA Sub-population	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.	Baseline, Week 12, Week 48, Week 72, Week 96
Height z-Score by Age Group for ERA Sub-population	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.	Baseline, Week 12, Week 48, Week 72, Week 96
Height z-Score by Age Group for PsA Sub-population	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.	Baseline, Week 12, Week 48, Week 72, Week 96
Weight z-Scores by Age Group	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.	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Weight z-Scores by Age Group for eoJIA Sub-population	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.	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Weight z-Scores by Age Group for ERA Sub-population	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.	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Weight z-Scores by Age Group for PsA Sub-population	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.	Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Body Mass Index (BMI) z-Score by Age Group	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.	Baseline, Week 12, Week 48, Week 72, Week 96
Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population	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.	Baseline, Week 12, Week 48, Week 72, Week 96
Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population	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.	Baseline, Week 12, Week 48, Week 72, Week 96
Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population	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.	Baseline, Week 12, Week 48, Week 72, Week 96
Number of Participants With Anti-etanercept Antibodies		Baseline up to Week 12, Week 48, Week 96
Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population		Baseline up to Week 12, Week 48, Week 96
Number of Participants With Anti-etanercept Antibodies: ERA Sub-population		Baseline up to Week 12, Week 48, Week 96
Number of Participants With Anti-etanercept Antibodies: PsA Sub-population		Baseline up to Week 12, Week 48, Week 96
Number of Participants With Neutralizing Anti-etanercept Antibodies		Baseline up to Week 12, Week 48, Week 96

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Foeldvari I, Constantin T, Vojinovic J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Susic G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dolezalova P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: August 13, 2009
• First Submitted That Met QC Criteria: August 19, 2009
• First Posted (Estimate): August 20, 2009

Study Record Updates

• Last Update Posted (Estimate): June 10, 2014
• Last Update Submitted That Met QC Criteria: May 29, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 0881A1-3338; B1801014