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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00531817 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 619 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without d
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 |
What the finished NCT00531817 record still lists
NCT00531817 is an interventional study that assigns participants to a tested intervention. The registered 619 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 (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00531817 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00531817's enrollment target sits among peer trials
619 591st of 2000 higher than 1,410 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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