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NCT00531817 · ClinicalTrials.gov registry record · Phase 3
A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 619
- Enrollment target
NCT00531817 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 619 participants.
The verdict
NCT00531817, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 619 participants
- Enrollment target
Study Summary
This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.
Interventions
- DRUG Placebo
- DRUG Tocilizumab
- DRUG Permitted DMARDs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 619 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00531817
The ClinicalTrials.gov registry entry for NCT00531817 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 619 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.
NCT00531817 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00531817 about?
NCT00531817 is a clinical study titled "A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis". This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARD...
What is the current status of trial NCT00531817?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 619 participants. The study started on 2007-10. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00531817?
The interventions under investigation include: Placebo (DRUG), Tocilizumab (DRUG), Permitted DMARDs (DRUG).
Who is sponsoring clinical trial NCT00531817?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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