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NCT00489489 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT00489489 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 118 participants.
The verdict
NCT00489489, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
Study Summary
The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of interferon-β \[IFN-β\]. Secondary objectives were: * to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β on Magnetic Resonance Imaging \[MRI\] parameters, relapse rate and patient-reported fatigue; * to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of IFN-β.
Interventions
- DRUG Teriflunomide
- DRUG Placebo (for Teriflunomide)
- DRUG Interferon-β
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00489489
The ClinicalTrials.gov registry entry for NCT00489489 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Teriflunomide is the first listed.
NCT00489489 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00489489 about?
NCT00489489 is a clinical study titled "Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis". The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of interferon-β \[IFN-β\]. Secondary objectives were: * to e...
What is the current status of trial NCT00489489?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2007-05. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00489489?
The interventions under investigation include: Teriflunomide (DRUG), Placebo (for Teriflunomide) (DRUG), Interferon-β (DRUG).
Who is sponsoring clinical trial NCT00489489?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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