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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00468546 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 520 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
American College of Rheumatology (ACR) 20 response is defined as \>= 20% improvement (reduction) in score compared with baseline for both tender joint count (TJC)-68 joints and swollen joint count (SJC)-66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) ranging from score 0 (no pain) to 100 (unbearable pain); Patient's Global Assessment of Disease Activity and Physician's Global Assessm
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 |
What the finished NCT00468546 record still lists
NCT00468546 is an interventional study that assigns participants to a tested intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00468546 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00468546's enrollment target sits among peer trials
520 717th of 2000 higher than 1,278 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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