MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT02468791|
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Rituximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||709 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||October 2017|
A course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
Active Comparator: MabThera®
A course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
- Percentage of patients in each treatment group achieving the primary efficacy endpoint of a ≥ 20% improvement on the American College of Rheumatology score (ACR20) at Week 24. [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468791