CTRI/2022/10/046212
Active, not recruiting
Phase 3
Comparative pharmacokinetic, pharmacodynamic,safety, efficacy and immunogenecity study ofVBRTXM01 (Virchow Rituximab) versus Ristova(Roche Rituximab) in patients with RheumatoidArthritis - Nil
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
- Sponsor
- Virchow Biotech Private Limited
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female patients aged between 18 – 60 years (both inclusive).
- •2\.History of rheumatoid arthritis, as defined by the American College of Rheumatology (ACR) Classification, for at least 6 months.
- •3\.Moderate to severe active RA seropositive disease.
- •4\.History of treatment with Methotrexate (MTX) 20\-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 procedures.
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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