Clinical trial
A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in…
NCT00468546 · Hoffmann-La Roche, Industry · Completed
Key facts
| NCT number | NCT00468546 |
|---|---|
| Title | A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy |
| Official title | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies |
| Lead sponsor | Hoffmann-La Roche, Industry |
| Collaborators | Biogen Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Rheumatoid Arthritis |
| Intervention type | Drug, Other |
| Interventions | MabThera/Rituxan, Methotrexate, Placebo |
| Enrollment | 520 |
| Start date | May 1, 2003 |
| Primary completion | Jan 1, 2005 |
| Completion | Jul 1, 2012 |
| First posted | May 2, 2007 |
| Last update posted | Oct 25, 2016 |
| Countries | Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, United Kingdom, United States |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: