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NCT00811395 · ClinicalTrials.gov registry record · Phase 2
Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 182
- Enrollment target
NCT00811395: Completed Phase 2 study, sponsored by Sanofi.
NCT00811395 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 182 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00811395, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 182 participants
- Enrollment target
Study Summary
The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[IFN-β\] or glatiramer Acetate \[GA\] in patients with multiple sclerosis \[MS\] with relapses. Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging \[MRI\] parameters. This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.
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 Interferon-β [IFN-β]
- DRUG Glatiramer Acetate [GA]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2007-10 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
What the finished NCT00811395 record still lists
NCT00811395 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 4 interventions - of which Teriflunomide is the first listed.
NCT00811395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00811395 about?
NCT00811395 is a clinical study titled "Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis". The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[IFN-β\] or glatiramer Acetate \[GA\] in patients with multiple sclerosis \[MS\] with relapses. Secondary objectives were to evaluate the long-term effect on relap...
What is the current status of trial NCT00811395?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2007-10. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00811395?
The interventions under investigation include: Teriflunomide (DRUG), Placebo (for teriflunomide) (DRUG), Interferon-β [IFN-β] (DRUG), Glatiramer Acetate [GA] (DRUG).
Who is sponsoring clinical trial NCT00811395?
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 NCT00811395's enrollment target sits among peer trials
182 363rd of 2000 higher than 1,636 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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