A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 428
- 主要终点
- Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of infliximab (an anti-TNF chimeric monoclonal antibody [cA2]) in patients with active Rheumatoid Arthritis, despite methotrexate treatment.
详细描述
This is a placebo-controlled, double-blinded, randomized clinical study to evaluate the safety and effectiveness of infliximab in patients with active Rheumatoid Arthritis, despite methotrexate treatment. Infliximab is an anti-TNF chimeric monoclonal antibody (cA2). The primary measures of effectiveness include the change from baseline in American College of Rheumatology (ACR20) response at week 30, and the change in the modified van der Heijde Sharp Score. The ACR20 Responder Index a composite of clinical, laboratory, and functional measures and the van der Heijde-Sharp (vdH-S) scoring method is a method of rating structural damage in patients..
Patients will be treated with either infliximab or matching placebo.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active Rheumatoid Arthritis despite treatment with methotrexate
- •Diagnosed with Rheumatoid Arthritis at least 6 months prior to screening
- •Having active disease at the time of screening and pre-infusion as defined by having at least 6 or more swollen joints and 6 or more tender joints
- •Using methotrexate for at least 3 months prior to study enrollment
排除标准
- •Patients having any systemic inflammatory condition
- •Having Lyme disease or a rheumatic disease other than Rheumatoid Arthritis
- •Who have used Disease-Modifying Antirheumatic Drugs (DMARDs) other than methotrexate within 4 weeks prior to screening
- •Who have used corticosteroids within 4 weeks prior to screening
- •Having received previous administration of infliximab
研究组 & 干预措施
Placebo
Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
干预措施: Placebo (Drug)
Infliximab 3 mg/kg every 8 weeks
Infliximab 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.
干预措施: Infliximab 3 mg/kg (Drug)
Infliximab 3 mg/kg every 4 weeks
Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.
干预措施: Infliximab 3 mg/kg (Drug)
Infliximab 10 mg/kg every 8 weeks
Infliximab 10 mg/kg will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.
干预措施: Infliximab 10 mg/kg (Drug)
Infliximab 10 mg/kg every 4 weeks
Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.
干预措施: Infliximab 10 mg/kg (Drug)
结局指标
主要结局
Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score
时间窗: Baseline and Week 30
次要结局
- safety(up to Week 54)