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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01044498 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 46 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples were collected prior to the administration of Ortho-Novum® 1/35 on Day 21 of each cycle. Serum levels of progesterone were quantitatively determined using the ADVIA Centaur and ADVIA Centaur XP systems (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA). The assay was a competitive immunoassay using direct chemiluminescent technology.
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 |
What the finished NCT01044498 record still lists
NCT01044498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Tocilizumab is the first listed.
NCT01044498 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01044498's enrollment target sits among peer trials
46 1868th of 2000 higher than 131 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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