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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 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 3,080 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01331837
The ClinicalTrials.gov registry entry for NCT01331837 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 3,080 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 is the first listed.
NCT01331837 reports 0 study locations.
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.
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