A randomized, double-blind, multicenter, phase 3 study to compare the efficacy and safety of BMO-2 (adalimumab) and HumiraÂ® (adalimumab) in patients with active rheumatoid arthritis - BMO-2

Biocon Research Limited0 个研究点目标入组 222 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1. Adult male and female patients diagnosed with RA for at least 4 months (as per 2010 ACR/EULAR criteria) and having a score >=6/10.
•2. 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.
•3. RA functional class I, II, or III.

•1. Rheumatoid arthritis with significant secondary involvement
•2. Treatment with DMARDs other than MTX within 4 weeks prior to screening (8 weeks prior for leflunomide, and azathioprine).
•3. Prior or current treatment with investigational or approved biologics for rheumatoid arthritis.
•4. History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder or diagnosis of JIA/JRA.
•5. 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.
•6. Chronic or current infectious disease
•7. Subjects with active or latent tuberculosis as evident from chest X ray and/or clinical signs and symptoms
•8. Subjects with a positive test for TB (Mantoux/PPD test or Quantiferon TB Gold/IGRA test).
•9. Evidence of significant uncontrolled concomitant diseases.
•10. Known active infection of any kind or any episode of infection requiring hospitalization or treatment with anti-infective within 30 days of dosing.
•11. Receipt of a live/attenuated vaccine within 28 days prior to randomization.
•12. History of use of intra-articular or parenteral glucocorticoids within 4 weeks prior to screening.

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