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NCT01252355 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 534
- Enrollment target
NCT01252355 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 534 participants.
The verdict
NCT01252355, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 534 participants
- Enrollment target
Study Summary
The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta). The secondary objectives were: * Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on: * Disease activity as measured by brain Magnetic Resonance Imaging (MRI) * Disability progression * Burden of disease and disease progression as measured by brain MRI * Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy * Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy * Assess associations between variations in genes and clinical outcomes (safety and efficacy) * Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life * Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)
Interventions
- DRUG Teriflunomide
- DRUG Placebo (for teriflunomide)
- DRUG Interferon-beta (IFN-beta)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 534 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01252355
The ClinicalTrials.gov registry entry for NCT01252355 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 534 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 3 interventions - of which Teriflunomide is the first listed.
NCT01252355 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01252355 about?
NCT01252355 is a clinical study titled "Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta". The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta). The secondary objectives were: * Assess the effect of teriflunomi...
What is the current status of trial NCT01252355?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 534 participants. The study started on 2011-01. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01252355?
The interventions under investigation include: Teriflunomide (DRUG), Placebo (for teriflunomide) (DRUG), Interferon-beta (IFN-beta) (DRUG).
Who is sponsoring clinical trial NCT01252355?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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