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临床试验/NCT00420238
NCT00420238已完成4 期

A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 82 人开始时间: 2007年1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
4 期
状态
已完成
发起方
入组人数
82
主要终点
Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and 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记录与标识符相似试验

研究概览

简要总结

Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

A

Experimental

干预措施: Etanercept (Enbrel) (Drug)

B

Placebo Comparator

干预措施: Placebo (Other)

结局指标

主要结局

Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12

时间窗: Baseline, Week 2, Week 4, Week 8, Week 12

BASDAI subject asessment of discomfort, pain and fatigue measured using a 100 millimeter Visual Analog Scale; range: 0=none to 100=very severe. Normalized net incremental area under the curve (AUC) = area between baseline and the BASDAI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.

次要结局

  • Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
  • Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
  • Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
  • Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
  • Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in Total Back Pain at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
  • Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1)(Baseline, Week 12)
  • Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)(Baseline, Week 12)
  • Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
  • Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12(Baseline, Week 2, Week 4, Week 8, Week 12)
  • Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24(Week 14, Week 18, Week 24)
  • Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12(Week 2, Week 4, Week 8, Week 12)
  • Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24(Week 14, Week 18, Week 24)

研究者

发起方
Wyeth is now a wholly owned subsidiary of Pfizer
申办方类型
Industry

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