drugset / Trial / NCT02468791

MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

NCT02468791 ↗

Phase 3 Completed 709 enrolled Mabion SA
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2013-05
Primary completion
2017-05
Completion
2017-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 1000 mg Intravenous

Indications