A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as add-on Medication to MTX in Japanese Active RA Patients Who Have an Incomplete Response to MTX.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 316
- 主要终点
- American College of Rheumatology 20% (ACR20) Response at Week 12
研究概览
简要总结
The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.
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 9 tender joints and 9 swollen joints
- •ESR of 30 mm/hour or CRP of 1.5 mg/dL
- •Subjects must have received treatment with MTX for at least 6 months prior to the start of study drug administration. The dose of MTX must have remain fixed for at least 2 months prior to the study and the dose of MTX should be within 6 to 8 mg/week.
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 100mg
200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
干预措施: CDP870 100mg (Drug)
CDP870 200mg
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
干预措施: CDP870 200mg (Drug)
CDP870 400mg
400mg CDP870 given every 2 weeks
干预措施: CDP870 400mg (Drug)
Placebo
Placebo given every 2 weeks
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)