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NCT00751881 · ClinicalTrials.gov registry record · Phase 3
An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,169
- Enrollment target
NCT00751881: Completed Phase 3 study, sponsored by Sanofi.
NCT00751881 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,169 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00751881, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,169 participants
- Enrollment target
Study Summary
The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS. Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression. Other secondary objectives were: * To assess the effect of the two doses of teriflunomide in comparison to placebo on: * Fatigue; * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being. * To evaluate the safety and tolerability of teriflunomide.
Primary Outcome
ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores. To account for the different treatment durations among partici
Interventions
- DRUG Placebo
- DRUG Teriflunomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,169 participants |
| Start Date | 2008-08 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT00751881 record still lists
NCT00751881 is an interventional study that assigns participants to a tested intervention. Its 1,169 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00751881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00751881 about?
NCT00751881 is a clinical study titled "An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis". The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS. Key secondary objective was to assess the effect of the two doses of teriflunomide, in compari...
What is the current status of trial NCT00751881?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,169 participants. The study started on 2008-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT00751881?
The interventions under investigation include: Placebo (DRUG), Teriflunomide (DRUG).
Who is sponsoring clinical trial NCT00751881?
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 NCT00751881's enrollment target sits among peer trials
1,169 237th of 2000 higher than 1,764 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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