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NCT00134563 · ClinicalTrials.gov registry record · Phase 3
Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,088
- Enrollment target
NCT00134563: Completed Phase 3 study, sponsored by Sanofi.
NCT00134563 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,088 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00134563, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,088 participants
- Enrollment target
Study Summary
The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: * to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue; * to evaluate the safety and tolerability of teriflunomide.
Primary Outcome
ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the 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 EDSS score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression mode
Interventions
- DRUG Teriflunomide
- DRUG Placebo (for teriflunomide)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,088 participants |
| Start Date | 2004-09 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT00134563 record still lists
NCT00134563 is an interventional study that assigns participants to a tested intervention. Its 1,088 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 (41% higher).
The record links to 0 conditions, and to 2 interventions - of which Teriflunomide is the first listed.
NCT00134563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00134563 about?
NCT00134563 is a clinical study titled "Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis". The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: * to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale...
What is the current status of trial NCT00134563?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,088 participants. The study started on 2004-09. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00134563?
The interventions under investigation include: Teriflunomide (DRUG), Placebo (for teriflunomide) (DRUG).
Who is sponsoring clinical trial NCT00134563?
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 NCT00134563's enrollment target sits among peer trials
1,088 268th of 2000 higher than 1,732 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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