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NCT01044498 · ClinicalTrials.gov registry record · Phase 3
A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 46
- Enrollment target
NCT01044498 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 46 participants.
The verdict
NCT01044498, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 46 participants
- Enrollment target
Study Summary
This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child bearing age. The RA patients received OC in combination with TCZ, whereas the healthy volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8 mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The healthy volunteers received OC for only one 21-day cycle.
Interventions
- DRUG Tocilizumab
- DRUG Ortho-Novum® 1/35
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01044498
The ClinicalTrials.gov registry entry for NCT01044498 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 46 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.
NCT01044498 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01044498 about?
NCT01044498 is a clinical study titled "A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis". This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child bearing age. The RA patients rec...
What is the current status of trial NCT01044498?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 46 participants. The study started on 2009-12. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01044498?
The interventions under investigation include: Tocilizumab (DRUG), Ortho-Novum® 1/35 (DRUG).
Who is sponsoring clinical trial NCT01044498?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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