Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse. The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.

Key facts

Study ID

NCT00803049

Run by

Sanofi

People needed

742

Starts

2006-10-01

Expected to finish

2015-12-01

Last updated by the study team

2017-01-30

Who can join

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

You may qualify if…

• Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal.
• Willingness to participate in a long-term safety/efficacy trial.

You may not qualify if…

• 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

• Investigational Site Number 1038 — Fort Wayne, Indiana, United States
• Investigational Site Number 1033 — Detroit, Michigan, United States
• Investigational Site Number 1037 — Allentown, Pennsylvania, United States
• Investigational Site Number 1603 — Graz, Austria
• Investigational Site Number 1604 — Innsbruck, Austria
• Investigational Site Number 1601 — Vienna, Austria
• Investigational Site Number 1602 — Vienna, Austria
• Investigational Site Number 1208 — Calgary, Canada
• Investigational Site Number 1212 — Gatineau, Canada
• Investigational Site Number 1205 — Greenfield Park, Canada
• Investigational Site Number 1201 — Halifax, Canada
• Investigational Site Number 1206 — London, Canada
• Investigational Site Number 1203 — Montreal, Canada
• Investigational Site Number 1204 — Ottawa, Canada
• Investigational Site Number 1202 — Québec, Canada
• Investigational Site Number 1211 — St. John's, Canada
• Investigational Site Number 1209 — Toronto, Canada
• Investigational Site Number 1210 — Vancouver, Canada
• Investigational Site Number 1207 — Winnipeg, Canada
• Investigational Site Number 3804 — Santiago, Chile
• Investigational Site Number 3802 — Santiago, Chile
• Investigational Site Number 3803 — Santiago, Chile
• Investigational Site Number 3801 — Santiago, Chile
• Investigational Site Number 3805 — Viña del Mar, Chile
• Investigational Site Number 1032 — Maitland, Florida, United States

Full record on ClinicalTrials.gov

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