CTRI/2016/02/006625已完成3 期
A randomized, double-blind, multicenter, phase 3 study to compare the efficacy and safety of BMO-2 (adalimumab) and Humira® (adalimumab) in patients with active rheumatoid arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 28
- 主要终点
- Proportion of patients achieving ACR 20 response at week 14.
研究概览
简要总结
This study is randomized, double-blind, multicenter, two-arm, parallel-group, phase 3 study to assess the efficacy and safety of BMO-2 and Humira® in combination with MTX in 140 patients with active rheumatoid arthritis. Patients will be randomized to receive either BMO-2 or Humira®, every other week until week 22, along with their background stable dose of MTX every week until week 24. End of trial safety follow up will be performed at week 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and female patients diagnosed with RA for at least 4 months (as per 2010 ACR/EULAR criteria) and having a score ≥6/
- •Patients with active RA defined as ≥6 swollen (out of 66) and ≥6 tender (out of 68) joint counts and CRP >8 mg/L despite taking MTX orally for ≥12 weeks and at a stable weekly dose of ≥12.5 mg (minimum of 10 mg if intolerant/contraindicated to further dose escalation) in the last 4 weeks prior to screening and plan to remain on stable dose throughout the study.
- •RA functional class I, II, or III.
排除标准
- •Rheumatoid arthritis with significant secondary involvement
- •Treatment with DMARDs other than MTX within 4 weeks prior to screening (8 weeks prior for leflunomide, and azathioprine).
- •Prior or current treatment with investigational or approved biologics for rheumatoid arthritis.
- •History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder or diagnosis of JIA/JRA.
- •Any surgical procedure, including bone/joint surgery/synovectomy within 12 weeks prior to screening or planned during the study or history of infected joint prosthesis within 5 years.
- •Chronic or current infectious disease
- •Subjects with active or latent tuberculosis as evident from chest X ray and/or clinical signs and symptoms
- •Subjects with a positive test for TB (Mantoux/PPD test or Quantiferon TB Gold/IGRA test).
- •Evidence of significant uncontrolled concomitant diseases.
- •Known active infection of any kind or any episode of infection requiring hospitalization or treatment with anti-infective within 30 days of dosing.
- •Receipt of a live/attenuated vaccine within 28 days prior to randomization.
- •History of use of intra-articular or parenteral glucocorticoids within 4 weeks prior to screening.
结局指标
主要结局
Proportion of patients achieving ACR 20 response at week 14.
时间窗: ACR 20 response at week 14.
次要结局
- •Proportion of patients achieving ACR 20 response at week 24.(•Proportion of patients achieving ACR 50 and ACR 70 response at weeks 14 and 24.)
研究者
研究点 (28)
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