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NCT01331837 · ClinicalTrials.gov registry record · Phase 4
A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 3,080
- Enrollment target
NCT01331837: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT01331837 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 3,080 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (495% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01331837, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 3,080 participants
- Enrollment target
Study Summary
This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).
Primary Outcome
Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke.
Interventions
- DRUG Tocilizumab
- DRUG Etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,080 participants |
| Start Date | 2011-08-02 |
| Est. Completion | 2016-03-25 |
| Phase | Phase 4 |
What the finished NCT01331837 record still lists
NCT01331837 is an interventional study that assigns participants to a tested intervention. Its 3,080 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (495% higher).
The record links to 0 conditions, and to 2 interventions - of which Tocilizumab is the first listed.
NCT01331837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01331837 about?
NCT01331837 is a clinical study titled "A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors". This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) to...
What is the current status of trial NCT01331837?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 3,080 participants. The study started on 2011-08-02. Estimated completion is 2016-03-25.
What interventions are being tested in trial NCT01331837?
The interventions under investigation include: Tocilizumab (DRUG), Etanercept (DRUG).
Who is sponsoring clinical trial NCT01331837?
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 NCT01331837's enrollment target sits among peer trials
3,080 25th of 2000 higher than 1,976 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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