drugset / Trial / NCT02468791
MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 1000 mg | Intravenous |