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NCT00475865 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT00475865: Completed Phase 2 study, sponsored by Sanofi.
NCT00475865 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00475865, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 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 to placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of Glatiramer Acetate \[GA\]. The secondary objectives were: * to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA 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 GA.
Primary Outcome
AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
Interventions
- DRUG Teriflunomide
- DRUG Placebo (for teriflunomide)
- DRUG Glatiramer Acetate (GA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00475865 record still lists
NCT00475865 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Teriflunomide is the first listed.
NCT00475865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00475865 about?
NCT00475865 is a clinical study titled "Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate 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 to placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of Glatiramer Acetate \[GA\]. The secondary objectives were: *...
What is the current status of trial NCT00475865?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2007-04. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00475865?
The interventions under investigation include: Teriflunomide (DRUG), Placebo (for teriflunomide) (DRUG), Glatiramer Acetate (GA) (DRUG).
Who is sponsoring clinical trial NCT00475865?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00475865's enrollment target sits among peer trials
123 564th of 2000 higher than 1,436 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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