GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/30/2017 |
| Start Date: | July 2015 |
| End Date: | October 2016 |
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®
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.
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.
Inclusion Criteria:
- Diagnosis of rheumatoid arthritis (RA) according to ACR 2010 criteria
- Completed one full treatment course with either Rituxan® or MabThera®
- Eligible for a further treatment course with Rituxan® or MabThera®- Currently treated
with methotrexate
Exclusion Criteria:
- RA functional status class IV (ACR 1991 revised criteria)
- Systemic manifestation of RA
- Positive serology for hepatitis B or hepatitis C infection
- Active systemic infection
- History of cancer
- Known severely immunocompromised state
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
40
sites
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Charlotte, North Carolina 28207
Phone: 704-342-0252
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Colorado Springs, Colorado 80910
Phone: 719-475-9616
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Long Beach, California 90806
Phone: 562-989-2374
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Tuscaloosa, Alabama 35406
Phone: 205-464-4711
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