CTRI/2013/05/003678招募中1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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 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 may not participate in this study until any of the following that are present have resolved.
- •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 (UNL).
- •c. Platelet count < 100,000/µL.
- •d. Hemoglobin < 8.0 g/dL.
- •e. Neutrophils < 1.5 Ã? 103/µL.
研究者
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