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NCT00468546 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 520
- Enrollment target
NCT00468546 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 520 participants.
The verdict
NCT00468546, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 520 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.
Interventions
- OTHER Placebo
- DRUG Methotrexate
- DRUG MabThera/Rituxan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 520 participants |
| Start Date | 2003-05 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00468546
The ClinicalTrials.gov registry entry for NCT00468546 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00468546 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00468546 about?
NCT00468546 is a clinical study titled "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". This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 par...
What is the current status of trial NCT00468546?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 520 participants. The study started on 2003-05. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00468546?
The interventions under investigation include: Placebo (OTHER), Methotrexate (DRUG), MabThera/Rituxan (DRUG).
Who is sponsoring clinical trial NCT00468546?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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