A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 319
- 主要终点
- Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
研究概览
简要总结
The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of radiographically confirmed joint damage progression over a one-year period as a primary endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be discontinued, and the subjects will be monitored for one more year (the follow-up period) to investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory purposes.
详细描述
This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with RA as defined by the ACR/EULAR criteria (2010) who meet all of the following criteria:
- •Subjects who developed RA within one year after onset of RA.
- •Subjects who have never received MTX before (MTX naive)
- •Subjects whose disease activity is moderate or higher (DAS28(ESR) ≥ 3.2）
- •Subjects must satisfy at least two of the three criteria (Anti-CCP antibody positive, Rheumatoid factor positive, Presence of X-ray erosion） for poor prognostic factors. The anti-CCP antibody positive is essential for every patient.
排除标准
- •Patients who have a diagnosis of any other type of inflammatory arthritis.
- •Patients who have a secondary, non-inflammatory type of arthritis.
- •Patients who have used with MTX, reflunomide, or any other biologics prior to the start of study drug administration.
- •Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
- •Patients who currently have, or who have a history of, tuberculosis.
- •Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
- •Patients who currently have, or have a history of, malignant tumor
- •Female patients who are breastfeeding or pregnant, who are of childbearing potential
研究组 & 干预措施
PBO + MTX
Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
干预措施: Placebo (Drug)
PBO + MTX
Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
干预措施: methotrexate (MTX) (Drug)
CZP + MTX
Participants who certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
干预措施: CZP (Drug)
CZP + MTX
Participants who certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
干预措施: methotrexate (MTX) (Drug)
结局指标
主要结局
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
时间窗: Baseline and Week 52
Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst).
次要结局
- Change From Baseline in mTSS at Week 24(Baseline and Week 24)
- Clinical Remission Rate: Percentage of Participants Meeting the Disease Activity Score-28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) (DAS28[ESR]) Remission Criteria at Weeks 24 and 52(Week 24 and Week 52)
- Clinical Remission Rate: Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Simplified Disease Activity Index (SDAI)-Based Remission Criteria at Weeks 24 and 52(Week 24 and Week 52)
- Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean-based Remission Criteria at Weeks 24 and 52(Week 24 and Week 52)