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临床试验/NCT00962741
NCT00962741已完成3 期

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

Pfizer1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2009年9月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Pfizer
入组人数
127
试验地点
1
主要终点
Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 17 Years（Child）
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

1

Experimental

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

干预措施: Etanercept (Drug)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Percentage of Participants With an ACR Pedi 30 Response(Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 50 Response(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 90 Response(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 70 Response(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Pain Assessment(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 an ACR Pedi 100 Response(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population(Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Physician's Global Assessment (PGA) of Disease Activity(Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population(Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population(Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population(Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Patient/Parent Global Assessment(Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Patient/Parent Global Assessment: eoJIA Sub-population(Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Patient/Parent Global Assessment: ERA Sub-population(Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)
  • Patient/Parent Global Assessment: PsA Sub-population(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(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(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(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(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(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(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(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(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)(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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