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NCT00803049 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 742
- Enrollment target
NCT00803049: Completed Phase 3 study, sponsored by Sanofi.
NCT00803049 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 742 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00803049, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 742 participants
- Enrollment target
Study Summary
The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse. The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.
Primary Outcome
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period which was defined as the period from the time of first dose of study drug (in LTS6050) up to 4 weeks (28 days) after last dose of study drug. Serious adverse event (SAE) was defined as any untoward medical o
Interventions
- DRUG Teriflunomide (HMR1726)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 742 participants |
| Start Date | 2006-10 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT00803049 record still lists
NCT00803049 is an interventional study that assigns participants to a tested intervention. The registered 742 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Teriflunomide (HMR1726) is the first listed.
NCT00803049 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00803049 about?
NCT00803049 is a clinical study titled "Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis". The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse. The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI...
What is the current status of trial NCT00803049?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 742 participants. The study started on 2006-10. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00803049?
The interventions under investigation include: Teriflunomide (HMR1726) (DRUG).
Who is sponsoring clinical trial NCT00803049?
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 NCT00803049's enrollment target sits among peer trials
742 476th of 2000 higher than 1,525 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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