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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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 182 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00811395
The ClinicalTrials.gov registry entry for NCT00811395 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Teriflunomide is the first listed.
NCT00811395 reports 0 study locations.
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.
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