Health Condition 1: null- moderate to severely active rheumatoid arthritis patients
Conditions
Interventions
Intervention1: BMO-2 (adalimumab): 40 mg SC (subcutaneous) administration every alternate week start from week 0 to week 22
Control Intervention1: Humira® (adalimumab): 40 mg SC (subcutaneous) admin
Sponsors
Biocon Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving ACR 20 response at week 14.Timepoint: ACR 20 response at week 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Proportion of patients achieving ACR 20 response at week 24. â?¢ Proportion of patients achieving ACR 50 and ACR 70 response at weeks 14 and 24. â?¢Change from baseline of the DAS 28-CRP at weeks 14 and 24. â?¢Change from baseline in physical function as assessed by HAQ-DI at weeks 14 and 24. â?¢Nature, frequency and severity of adverse events (AEs). â?¢Detection of antidrug antibodies (binding and neutralizing) over 24 weeks. Timepoint: â?¢ACR 20 response at week 24. â?¢ACR 50 and ACR 70 response at weeks 14 and 24. â?¢DAS 28-CRP at weeks 14 and 24. â?¢HAQ-DI at weeks 14 and 24. â?¢Antidrug antibodies (binding and neutralizing) over 24 weeks. | — |
Countries
India
Contacts
Public ContactMs Jayanti Panda
Biocon Research Limited,
Outcome results
None listed