Trials / Completed
CompletedNCT02514772
GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study objective is to identify potential safety risks of the transition from US-licensed Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to continuous treatment with the originator product in terms of general safety and immunogenicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GP2013 - A Proposed biosimilar rituximab | |
| BIOLOGICAL | Originator rituximab - Rituxan ® or MabThera ® |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-07-01
- Completion
- 2016-10-01
- First posted
- 2015-08-04
- Last updated
- 2017-12-28
- Results posted
- 2017-12-28
Locations
65 sites across 4 countries: United States, Germany, Hungary, Poland
Source: ClinicalTrials.gov record NCT02514772. Inclusion in this directory is not an endorsement.