A Prospective, Comparative, Open Label, Randomized, Multicentric Phase III study to compare the safety and efficacy of etanercept of Intas Biopharmaceuticals Ltd against Enbrel® in patients with Active Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- Percentage of patients achieving a 20% ACR response rate
研究概览
简要总结
Rheumatoid arthritis occurs in approximately 1% of the adult population and is associated with progressive joint destruction, functional disability, and decreased life expectancy. Disease modifying antirheumatic drugs (DMARDs), such as methotrexate, sulfasalazine, and hydroxychloroquine, may retard disease progression. However, many patients do not achieve an adequate response, and many do not maintain a response because of toxicity or lack of efficacy.Although the underlying cause of rheumatoid arthritis is unknown, tumor necrosis factor TNF-a, a proinflammatory cytokine produced by macrophages and T cell contributes to the pathogenesis of synovitis and joint destruction. Because of the involvement of TNF in the pathogenesis of rheumatoid arthritis, it was hypothesized that soluble recombinant human TNF receptors might be useful as therapy for this disease. Etanercept is a recombinant human TNF receptor Fc fusion protein, fused to the Fc portion of human IgG1. Previous trials in patients with active rheumatoid arthritis who had an inadequate response to DMARDs have shown etanercept to be safe, well tolerated, and able to produce significant dose-dependent improvements in disease activity.The innovator product Enbrel marketed by Wyeth Limited has recently been approved by various regulatory including the US Food and Drug Administration (FDA), European and DCGI for treatment of RA.Intas Biopharmaceuticals Ltd (IBPL) has developed biosimilar product etanercept. IBPL had already conducted non-clinical studies of test product to prove safety profile of test product at human intended dose. The current study is planned to compare the safety and efficacy of etanercept manufactured by Intas Biopharmaceuticals Limited against the comparator product Enbrel for the treatment of Active Rheumatoid Arthritis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with active Rheumatoid Arthritis diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis Subjects with Global Functional Status Assessment.
- •class I, II or III according to the revised criteria of the American College of Rheumatology (ACR).
排除标准
- •1.Previous treatment with DMARDs except methotrexate 2.Known hypersensitivity to etanercept or any of the components of study medication 3.Patients with history of tuberculosis in the past or having findings suggestive of active tuberculosis or latent tuberculosis 4.Pregnant or breast-feeding patients 5.History of blood dyscrasias 6.Patients with history of alcohol, drug or chemical abuse 7.Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, cancer, uncontrolled diabetes, neurologic or psychiatric disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
结局指标
主要结局
Percentage of patients achieving a 20% ACR response rate
时间窗: at 12 weeks
次要结局
- Percentage of patients achieving a 50% ACR response rate(at 12 weeks)
- Mean change in DAS28 score and HAQ score from baseline(at 12 weeks)