Trials / Completed
CompletedNCT02468791
MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 709 (actual)
- Sponsor
- Mabion SA · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Subjects who meet the criteria for participation in this study receive 2 intravenous infusions of MabionCD20® or MabThera® with two weeks interval in combination with methotrexate and folic acid. After the treatment period, patients are followed for 24 weeks, in order to continue checking safety. Therefore, the total study lasts 48 weeks. There is a possibility to repeat treatment after 6 months of the first infusions if subject meets the retreatment criteria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2017-05-01
- Completion
- 2017-10-01
- First posted
- 2015-06-11
- Last updated
- 2020-05-14
Locations
51 sites across 5 countries: Bosnia and Herzegovina, Georgia, Poland, Serbia, Ukraine
Source: ClinicalTrials.gov record NCT02468791. Inclusion in this directory is not an endorsement.