Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: * to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue; * to evaluate the safety and tolerability of teriflunomide.

Key facts

Study ID

NCT00134563

Run by

Sanofi

People needed

1088

Starts

2004-09-01

Expected to finish

2010-07-01

Last updated by the study team

2013-01-04

Who can join

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

You may qualify if…

• Multiple sclerosis [MS] subject who was ambulatory (EDSS of ≤ 5.5)
• Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
• Meeting McDonald's criteria for MS diagnosis;
• Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
• No relapse onset in the preceding 60 days prior to randomization;
• Clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone [ACTH] or systemic steroid treatment.

You may not qualify if…

• Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
• Significantly impaired bone marrow function;
• Pregnant or nursing woman;
• Alcohol or drug abuse;
• Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
• Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States
• Sanofi-Aventis Austria — Vienna, Austria
• sanofi-aventis, Canada — Laval, Canada
• Sanofi-Aventis — Santiago, Chile
• Sanofi-Aventis Administrative Office — Prague, Czechia
• sanofi-aventis Denmark — Hørsholm, Denmark
• Sanofi-Aventis Administrative Office — Tallinn, Estonia
• sanofi-aventis Finland — Helsinki, Finland
• sanofi-aventis France — Paris, France
• Sanofi-Aventis Deutschland GmbH — Berlin, Germany
• Sanofi-Aventis — Milan, Italy
• Sanofi-Aventis — Gouda, Netherlands
• Sanofi-Aventis — Lysaker, Norway
• sanofi-aventis Poland — Warsaw, Poland
• Sanofi-Aventis — Porto Salvo, Portugal
• Sanofi-Aventis — Moscow, Russia
• Sanofi-Aventis — Bromma, Sweden
• Sanofi-Aventis Switzerland — Geneva, Switzerland
• sanofi-aventis Turkey — Istanbul, Turkey (Türkiye)
• Sanofi-Aventis Administrative Office — Kiev, Ukraine
• sanofi-aventis UK — Guildford, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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