CTRI/2013/05/003678
Recruiting
Phase 1
â??A randomized controlled study to evaluate pharmacokinetic, pharmacodynamic (efficacy) and safety of Rituximab (Zydus) and Rituximab (Roche) in patients with Rheumatoid Arthritis.â?? - NA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Rheumatoid ArthritisHealth Condition 2: M069- Rheumatoid arthritis, unspecified
- Sponsor
- Cadila Healthcare Limited
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults subjects of either gender in age group of \>\= 18 year and \<\=70 years.
- •2\. History of rheumatoid arthritis, as defined by the American College of Rheumatology (ACR) Classification1, for atleast 6 months.
- •3\. Moderate to severe active seropositive disease.
- •4\. History of treatment with Methotrexate (MTX) 10\-25mg per week for at least 12 weeks with last 4 weeks at the stable dose before screening.
- •5\. If female and of childbearing potential, she shall have a negative pregnancy test at the time of screening and agrees to use adequate contraception throughout the study period.
- •6\. Able and willing to give written informed consent and comply with the requirements of the study protocol.
Exclusion Criteria
- •1\. Patients with significant systemic manifestations of RA.
- •2\. Female nursing patients.
- •3\. Rheumatic autoimmune disease other than RA.
- •4\. History of diagnosis of juvenile idiopathic arthritis (also known as juvenile rheumatoid arthritis) and/or RA before age 16\.
- •5\. History of inflammatory arthritis other than RA (e.g., inflammatory bowel disease, systemic lupus erythematosus (SLE), or psoriatic arthritis).
- •6\. Any surgical procedure, including bone/joint surgery or planned surgery within 8 weeks prior to screening or during the study period.
- •7\. Functional Class IV as defined by the American College of Rheumatology (ACR) classification of functional status in RA2\.
- •8\. History of use of disease\-modifying anti\-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to randomization (8 weeks prior for infliximab, adalimumab, or leflunomide).
- •9\. Treatment with any investigational agent within 4 weeks of screening or 5 half\-lives of the investigational drug (whichever is longer).
- •10\. Previous treatment with Rituximab.
Outcomes
Primary Outcomes
Not specified
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