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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: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT01252355 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 534 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. 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 Expanded Disability Status Scale (EDSS) score or Functional System scores. To account for the different treatment durations among participants,
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 |
Why NCT01252355 stopped before completion
NCT01252355 is an interventional study that assigns participants to a tested intervention. The registered 534 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 3 interventions - of which Teriflunomide is the first listed.
NCT01252355 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01252355's enrollment target sits among peer trials
534 703rd of 2000 higher than 1,297 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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