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临床试验/NCT01521923
NCT01521923已完成3 期

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis

UCB Pharma205 个研究点 分布在 1 个国家目标入组 359 人开始时间: 2012年1月1日最近更新:
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适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
UCB Pharma
入组人数
359
试验地点
205
主要终点
Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring
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 is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.

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 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •- Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

排除标准

  • •- Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

研究组 & 干预措施

CZP 200 mg Q2W + Methotrexate

Experimental

干预措施: Certolizumab Pegol + Methotrexate (MTX) (Biological)

CZP 200 mg Q4W + Methotrexate

Experimental

干预措施: Certolizumab Pegol + Methotrexate (MTX) (Biological)

Placebo + Methotrexate

Placebo Comparator

干预措施: Placebo + Methotrexate (MTX) (Biological)

结局指标

主要结局

Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring

时间窗: Week 104 in RA0055 Period 2

This Outcome Measure includes all subjects that have a DAS28 \[ESR\] \<= 3.2 from the start of RA0055 Period 2 (Week 52 of RA0055 Period 1) to Week 104 in RA0055 Period 2 without flaring.

次要结局

  • Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2(From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Percentage of Subjects With Disease Activity Score 28 [ESR] (DAS28 [ESR]) < 2.6 at Week 52 in Previous Study RA0055 Period 1 Who Maintain a DAS28 [ESR] < 2.6 From Week 52 in RA0055 Period 1 Through Week 104 in RA0055 Period 2 Without Flaring(From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2(From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2(From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Change From Baseline in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2(From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Change From Week 52 in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2(From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2(From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2(From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Change From Baseline in Previous Study RA0055 Period 1 in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 104 in RA0055 Period 2(From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2)
  • Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)
  • Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2(Week 104 in RA0055 Period 2)

研究者

发起方
UCB Pharma
申办方类型
Industry
责任方
Sponsor

研究点 (205)

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