Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 886 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00891020
The ClinicalTrials.gov registry entry for NCT00891020 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 886 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 2 interventions - of which tocilizumab [RoActemra/Actemra] is the first listed.
NCT00891020 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.