MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and the reference product - MabThera® (rituximab) and to demonstrate comparative safety and tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with moderate to severe active rheumatoid arthritis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mabion SA
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Patients with active rheumatoid arthritis with disease duration minimum 6 months prior to screening visit

• Patients who are naive to tumor necrosis factor (TNF) antagonists or any other monoclonal antibody therapies

• Patients who have had an inadequate response to an adequate regimen of methotrexate

Exclusion Criteria:

• History of current rheumatic autoimmune disease other than RA and current inflammatory joint disease other than RA

• Contraindications according to the MabThera SmPC and every serious coexisting diseases which, in the Investigator's opinion, would preclude subject participation

• Positive tests for HIV, hepatitis B surface antigen (HBsAg) Anti-HBc antibody, hepatitis C antibody

• Prior treatment with rituximab, other anti-CD20 mAb, anti-TNF-alpha drug or any other monoclonal antibodies

• Pregnancy or lactation or women planning to get pregnant during the course of the study and/or within 12 months post last study drug infusion

• Allergic reaction or intolerance to rituximab, MabionCD20 or any of their components

• Severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or previous treatment of any lymphocyte-depleting therapies