An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS. Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression. Other secondary objectives were: * To assess the effect of the two doses of teriflunomide in comparison to placebo on: * Fatigue; * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being. * To evaluate the safety and tolerability of teriflunomide.

Key facts

Study ID

NCT00751881

Run by

Sanofi

People needed

1169

Starts

2008-08-01

Expected to finish

2015-08-01

Last updated by the study team

2016-07-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Relapsing multiple sclerosis,
• Two relapses in prior 2 years or one relapse in prior year.

You may not qualify if…

• Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
• Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
• Pregnant or nursing woman,
• Alcohol or drug abuse,
• Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
• Human immunodeficiency virus (HIV) positive,
• Any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Sanofi-Aventis Investigational Site Number 840084 — Tucson, Arizona, United States
• Sanofi-Aventis Investigational Site Number 840008 — Loma Linda, California, United States
• Sanofi-Aventis Investigational Site Number 840034 — Modesto, California, United States
• Sanofi-Aventis Investigational Site Number 840090 — Fort Collins, Colorado, United States
• Sanofi-Aventis Investigational Site Number 840011 — Fairfield, Connecticut, United States
• Sanofi-Aventis Investigational Site Number 840013 — Maitland, Florida, United States
• Sanofi-Aventis Investigational Site Number 840083 — Ocala, Florida, United States
• Sanofi-Aventis Investigational Site Number 840086 — Ormond Beach, Florida, United States
• Sanofi-Aventis Investigational Site Number 840025 — Sarasota, Florida, United States
• Sanofi-Aventis Investigational Site Number 840015 — St. Petersburg, Florida, United States
• Sanofi-Aventis Investigational Site Number 840033 — Sunrise, Florida, United States
• Sanofi-Aventis Investigational Site Number 840063 — Elk Grove Village, Illinois, United States
• Sanofi-Aventis Investigational Site Number 840064 — Flossmoor, Illinois, United States
• Sanofi-Aventis Investigational Site Number 840039 — Fort Wayne, Indiana, United States
• Sanofi-Aventis Investigational Site Number 840012 — Indianapolis, Indiana, United States
• Sanofi-Aventis Investigational Site Number 840016 — Des Moines, Iowa, United States
• Sanofi-Aventis Investigational Site Number 840069 — Clinton Township, Michigan, United States
• Sanofi-Aventis Investigational Site Number 840075 — Grand Rapids, Michigan, United States
• Sanofi-Aventis Investigational Site Number 840061 — Traverse City, Michigan, United States
• Sanofi-Aventis Investigational Site Number 840076 — Minneapolis, Minnesota, United States
• Sanofi-Aventis Investigational Site Number 840079 — Tupelo, Mississippi, United States
• Sanofi-Aventis Investigational Site Number 840088 — St Louis, Missouri, United States
• Sanofi-Aventis Investigational Site Number 840060 — Syracuse, New York, United States
• Sanofi-Aventis Investigational Site Number 840029 — Charlotte, North Carolina, United States
• Sanofi-Aventis Investigational Site Number 840041 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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