Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta
Public ClinicalTrials.gov record NCT01252355. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT01252355
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 534 participants
Conditions and interventions
Conditions
Interventions
- Teriflunomide Drug
- Placebo (for teriflunomide) Drug
- Interferon-beta (IFN-beta) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2010
- Primary completion
- Mar 31, 2013
- Completion
- Mar 31, 2013
- Last update posted
- Jun 8, 2014
2011 – 2013
United States locations
- U.S. sites
- 32
- U.S. states
- 21
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840049 | Cullman | Alabama | 35058 | — |
| Investigational Site Number 840005 | Cordova | Alaska | 38018 | — |
| Investigational Site Number 840003 | Phoenix | Arizona | 85060 | — |
| Investigational Site Number 840011 | Oceanside | California | 92056 | — |
| Investigational Site Number 840036 | Fort Collins | Colorado | 80528 | — |
| Investigational Site Number 840012 | Maitland | Florida | 32761 | — |
| Investigational Site Number 840013 | Ormond Beach | Florida | 32174 | — |
| Investigational Site Number 840055 | Pompano Beach | Florida | 33060 | — |
| Investigational Site Number 840021 | St. Petersburg | Florida | 33713 | — |
| Investigational Site Number 840004 | Tampa | Florida | 33609-4052 | — |
| Investigational Site Number 840047 | Tampa | Florida | 33612 | — |
| Investigational Site Number 840034 | Chicago | Illinois | 60637 | — |
| Investigational Site Number 840037 | Elk Grove Village | Illinois | 60007 | — |
| Investigational Site Number 840033 | Louisville | Kentucky | 40217 | — |
| Investigational Site Number 840041 | Baltimore | Maryland | 21201 | — |
| Investigational Site Number 840028 | Baltimore | Maryland | 21287 | — |
| Investigational Site Number 840016 | Clinton Township | Michigan | 48035 | — |
| Investigational Site Number 840031 | St Louis | Missouri | 63104 | — |
| Investigational Site Number 840030 | St Louis | Missouri | 63110 | — |
| Investigational Site Number 840009 | Missoula | Montana | 59802 | — |
| Investigational Site Number 840023 | Albuquerque | New Mexico | 87131 | — |
| Investigational Site Number 840015 | New York | New York | 10029 | — |
| Investigational Site Number 840027 | Charlotte | North Carolina | 28204 | — |
| Investigational Site Number 840006 | Bismarck | North Dakota | 58501 | — |
| Investigational Site Number 840007 | Fargo | North Dakota | 58103 | — |
| Investigational Site Number 840046 | Dayton | Ohio | 45409 | — |
| Investigational Site Number 840017 | Toledo | Ohio | 43699 | — |
| Investigational Site Number 840043 | Tulsa | Oklahoma | 74137 | — |
| Investigational Site Number 840002 | Nashville | Tennessee | 37232 | — |
| Investigational Site Number 840040 | Round Rock | Texas | 78681 | — |
| Investigational Site Number 840020 | San Antonio | Texas | 78231 | — |
| Investigational Site Number 840032 | Vienna | Virginia | 22182 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 153 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01252355, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 8, 2014 · Synced Sep 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01252355 live on ClinicalTrials.gov.