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NCT00891020 · ClinicalTrials.gov registry record · Phase 3
A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 886
- Enrollment target
NCT00891020: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00891020 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 886 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00891020, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 886 participants
- Enrollment target
Study Summary
This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk mitigation strategies developed in partnership with the FDA to manage known and potential risks associated with the treatment of tocilizumab. Patients will be randomized to receive tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.
Primary Outcome
An SAE was any adverse event that at any dose fulfilled at least one of the following criteria: * Was fatal (results in death) * Was life-threatening * Required in-patient hospitalization or prolongation of existing hospitalization * Resulted in persistent or significant disability/incapacity * Was a congenital anomaly/birth defect * Was medically significant or required intervention to prevent one or other of the outcomes listed above.
Interventions
- DRUG tocilizumab [RoActemra/Actemra]
- DRUG Nonbiologic DMARDs of investigator's choice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 886 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
What the finished NCT00891020 record still lists
NCT00891020 is an interventional study that assigns participants to a tested intervention. The registered 886 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which tocilizumab [RoActemra/Actemra] is the first listed.
NCT00891020 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00891020 about?
NCT00891020 is a clinical study titled "A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)". This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk mitigation strategies develo...
What is the current status of trial NCT00891020?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 886 participants. The study started on 2009-05. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00891020?
The interventions under investigation include: tocilizumab [RoActemra/Actemra] (DRUG), Nonbiologic DMARDs of investigator's choice (DRUG).
Who is sponsoring clinical trial NCT00891020?
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 NCT00891020's enrollment target sits among peer trials
886 364th of 2000 higher than 1,636 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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