NCT01519791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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 880
- 试验地点
- 203
- 主要终点
- Percentage of Subjects in Sustained Remission at Week 52
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 inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.
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
- •Subjects must have a time since diagnosis of adult-onset Rheumatoid Arthritis (RA) less than 1 year as defined by the 2010 ACR/EULAR classification criteria from Screening Visit
- •Positive Rheumatoid Factor (RF) and/or positive anticyclic Citrullinated Peptide Antibody (anti-CCP)
- •Active RA disease
- •DMARD-naïve
- •Subject is naïve to RA related biologics
排除标准
- •A diagnosis of any other inflammatory Arthritis
- •History of infected joint prosthesis, or other significant infection and other serious medical condition
- •Known Tuberculosis (TB) disease or high risk of acquiring TB infection
结局指标
主要结局
Percentage of Subjects in Sustained Remission at Week 52
时间窗: Week 52
Sustained remission is defined as a Disease Activity Score \[Erythrocyte Sedimentation Rate\] (DAS28\[ESR\]) \< 2.6 at both Weeks 40 and 52. DAS28\[ESR\] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
次要结局
- Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52(Week 52)
- Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52(From Baseline (Week 0) to Week 52)
- Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52(From Baseline (Week 0) to Week 52)
- Change From Baseline in the Joint Erosion Score to Week 52(From Baseline (Week 0) to Week 52)
- Change From Baseline in the Joint Narrowing Score to Week 52(From Baseline (Week 0) to Week 52)
- Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52(From Baseline (Week 0) to Week 52)
- Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52(From Baseline (Week 0) to Week 52)
- Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52(From Baseline (Week 0) to Week 52)
- Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52(Week 52)
- Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52(Week 52)
- Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 52(Week 52)
- Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52(From Baseline (Week 0) to Week 52)
- Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52(Week 52)
- Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52(Week 52)
- Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52(Week 52)
- Percentage of Subjects With Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52(Week 52)
- Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52(From Baseline (Week 0) to Week 52)
- Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52(From Baseline (Week 0) to Week 52)
- Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52(From Baseline (Week 0) to Week 52)
- Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52(From Baseline (Week 0) to Week 52)
- Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52(Week 52)
- Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52(Week 52)
- Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52(Week 52)
- Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52(From Baseline (Week 0) to Week 52)
- Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52(Week 52)
- Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52(Week 52)
- Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52(Week 52)
- Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52(Week 52)
- Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52(Week 52)
研究者
研究点 (203)
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