A Prospective, Randomized, Multiple-Dose, Multi-Center,Comparative, Parallel Group Clinical Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Intravenous Injection of Tocilizumab (Hetero Biopharma Limited) and Reference Medicinal Product (Tocilizumab - Roche) Concomitantly Administered with Methotrexate in Patients with RheumatoidArthritis

Hetero Biopharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•1. Adult male or female patients of age 18 to 65 years (both inclusive)
•2. Patients with diagnosis of Active Rheumatoid Arthritis as per the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for RA score of >=6 and has a disease duration of at least three months before randomization
•3. Patients with Swollen Joint Count (SJC) >=6 (66 joint count), and Tender Joint Count (TJC) >=6 (68 joint count) at screening and randomization
•4. Patients with erythrocyte sedimentation rate of more than 28mm/hr measured by Westergren method and/or C-reactive protein >=10 mg/L
•5. Patients who are on NSAIDs, must be on a stable dose for at least 8 weeks prior to randomization.
•6. The screening laboratory tests must be: Haemoglobin >=9.0 g/dL, Absolute Neutrophil Count >=2.0 Ã? 109/L, Platelets >=100 Ã? 109/L, SGOT and SGPT <= ULN, Alkaline phosphatase levels <= ULN, Serum creatinine <=1.5 mg/d

•1. Patients with known or suspected allergy or
•hypersensitivity to Tocilizumab or excipients
•2. Patients with functional class IV disease as defined by the American College of Rheumatology (ACR) classification of functional status in RA
•3. Patients with history of use of biological disease modifying anti-rheumatic drugs (bDMARDs) within 8 weeks prior to randomization.
•4. Patients with history of intra-articular or parenteral corticosteroids use within 8 weeks prior to randomization.
•5. Patients with active systemic bacterial, viral, fungal, mycobacterial, or other infections
•6. Patients with history of treatment with intravenous antibiotics within 30 days or oral antibiotics within 14 days prior to randomization
•7. Patients with history or signs of lymphoproliferative disease
•8. Patients who received live or live-attenuated vaccine within 8 weeks prior to randomization
•9. Patients participated in an investigational drug study within 8 weeks prior to randomization.
•10. Patients with history of blood donation or blood loss of >300ml within 3 months prior to randomization

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