Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: VBRTXM01: Rituximab 1000 mg intravenous infusion on Day 1 and day 15 after pre-medication treatment with Methylprednisolone 100 mg IV 30 minutes prior to infusion of Rituximab
Control I
Sponsors
Virchow Biotech Private Limited
Eligibility
Inclusion 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
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. 11. Previous treatment with any cell-depleting therapies, including investigational agents. 12. Treatment with IV gamma-globulin or plasma filtering device like Prosorba (R) Column within the previous 6 months. 13. Receipt of a live vaccine within 4 weeks prior to Day 1 infusion. 14. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. 15. History of primary or secondary immunodeficiency 16. Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, renal, hepatic, endocrine, gastrointestinal, or pulmonary disease, including any pulmonary or other condition that would preclude subject participation. 17. Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds). 18. History of recurrent significant infection or any significant episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening. 19. History of cancer, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinoma of the skin that have been excised and cured). 20. Lack of peripheral venous access. 21. History of chronic daily use of narcotic analgesics. 22. History of alcohol, drug, or chemical abuse within 6 months prior to screening. 23. Positive Hepatitis B surface antigen or antibodies to Hepatitis C. 24. History of significant cytopenias or other bone marrow disorders. 25. Laboratory Exclusion Criteria: Patients with following abnormal values will be excluded : a. Serum creatinine > 1.4 mg/dL for women or 1.6 mg/dL for men. b. AST or ALT > 2.5 times upper limit of normal. c. Platelet count d. Hemoglobin e. Neutrophils f. IgG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with ACR 50 response at week 24Timepoint: Percentage of patients with ACR 50 response at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with ACR20 response at 12 weeks 2. Percentage of patients with ACR20 response at 24 weeks 3. Percentage of patients with ACR50 response at 24 weeks 4. Percentage of patients with ACR70 response at 24 weeks 5. Mean Change in Disease Activity Score 28 CRP from baseline to 24 weeks. 6. Mean change in C Reactive Protein from baseline to 24 weeks. 7. Mean change in HAQ-DI score from baseline to 24 weeks. 8. Single dose pharmacokinetic profile - Cmax, Tmax, AUC0-t. 9. Single dose pharmacodynamic parameter – CD19 B cell count on day 3, 7 and 15. 10. Percentage of patients who develop anti-drug antibodies in both groups. Timepoint: at 12 and 24 weeks | — |
Countries
India
Contacts
Public ContactDr T C Raghuram
Virchow Biotech Private Limited
Outcome results
None listed