A clinical Trial to evaluate efficacy and safety of BMO-2 and Adalimumab in patient with active rheumatoid arthritis
- Conditions
- Health Condition 1: null- moderate to severely active rheumatoid arthritis patients
- Registration Number
- CTRI/2016/02/006625
- Lead Sponsor
- Biocon Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 222
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving ACR 20 response at week 14.Timepoint: ACR 20 response at week 14.
- Secondary Outcome Measures
Name Time Method â?¢Proportion of patients achieving ACR 20 response at week 24. <br/ ><br>â?¢Proportion of patients achieving ACR 50 and ACR 70 response at weeks 14 and 24. <br/ ><br>â?¢Change from baseline of the DAS 28-CRP at weeks 14 and 24. <br/ ><br>â?¢Change from baseline in physical function as assessed by HAQ-DI at weeks 14 and 24. <br/ ><br>â?¢Nature, frequency and severity of adverse events (AEs). <br/ ><br>â?¢Detection of antidrug antibodies (binding and neutralizing) over 24 weeks. <br/ ><br>Timepoint: â?¢ACR 20 response at week 24. <br/ ><br>â?¢ACR 50 and ACR 70 response at weeks 14 and 24. <br/ ><br>â?¢DAS 28-CRP at weeks 14 and 24. <br/ ><br>â?¢HAQ-DI at weeks 14 and 24. <br/ ><br>â?¢Antidrug antibodies (binding and neutralizing) over 24 weeks. <br/ ><br>