A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 主要终点
- American College of Rheumatology 20% (ACR20) Response at Week 12
研究概览
简要总结
The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a diagnosis of adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria.
- •Subjects must have active RA disease as defined by:
- •At least 6 tender joints and 6 swollen joints
- •ESR of 28 mm/hour or CRP of 2.0 mg/dL
- •Subjects who have failed to respond or have been resistant to at least one DMARD (including MTX)
- •Subjects in whom MTX cannot be administered for any of the reasons(incomplete response/safety concerns)
排除标准
- •Patients who have a diagnosis of any other inflammatory arthritis
- •Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
- •Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)
- •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 who have a history of, malignancy
- •Female patients who are breastfeeding or pregnant, who are of childbearing potential
- •Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.
研究组 & 干预措施
CDP870 200mg
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
干预措施: CDP870 (Drug)
Placebo
Placebo of CDP870
干预措施: Placebo of CDP870 (Drug)
结局指标
主要结局
American College of Rheumatology 20% (ACR20) Response at Week 12
时间窗: Baseline, Week 12
ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)
次要结局
- American College of Rheumatology 20% (ACR20) Response at Week 24(Baseline, Week 24)