A Study to Assess the Efficacy and Safety of Retreatment With MabThera (Rituximab) in Patients With Active Rheumatoid Arthritis (RA)
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2002 |
| End Date: | October 2013 |
A Randomized, Open-label Study of the Effect of MabThera Retreatment on Treatment Response in Patients With Rheumatoid Arthritis
This study will assess the long-term safety and efficacy of repeating treatment with
MabThera, in combination with methotrexate and steroids, in patients who were previously
randomized into studies WA16291 or WA17043. The anticipated time on study treatment is until
Mabthera is available on the local market and the target sample size is 100-500 individuals.
MabThera, in combination with methotrexate and steroids, in patients who were previously
randomized into studies WA16291 or WA17043. The anticipated time on study treatment is until
Mabthera is available on the local market and the target sample size is 100-500 individuals.
Inclusion Criteria:
- adult patients, >=21 years of age, with active RA;
- completed 24 weeks of treatment in WA16291 or WA17043;
- eligible for re-treatment, based on clinical symptoms;
- females of childbearing potential using reliable contraception.
Exclusion Criteria:
- patients who participated in MabThera studies WA16291 or WA17043 but withdrew into
the safety follow-up phases of these trials;
- current treatment with any other disease-modifying drug (apart from methotrexate), or
any anti-TNFalfa, anti-IL1, or other biologic therapies;
- development of any new contraindications to receiving MabThera;
- female patients who are pregnant or breastfeeding.
We found this trial at
40
sites
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426 Maroochydore Road
Maroochydore, Queensland 4558
Maroochydore, Queensland 4558
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