Multiple Sclerosis Clinical Trial
Official title:
Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses
The primary objective of this study is to document the long-term safety and tolerability of
teriflunomide in Multiple Sclerosis (MS) patients with relapse.
The secondary objective is to document the long-term efficacy on disability progression,
relapse rate and Magnetic Resonance Imaging (MRI) parameters.
Patients completing the EFC6049 (HMR1726D/3001) study are given the opportunity to continue
in the extension study;
- patients receiving teriflunomide 7 mg or 14 mg are blindly maintained on the same dose
of teriflunomide.
- patients receiving placebo are randomized to teriflunomide 7 mg or 14 mg.
The study period per patient is broken down as follows:
- Double-blind treatment: up to a maximum of 288 weeks or until teriflunomide is
commercially available in the country where patient lives,
- Post-washout follow-up: 4 weeks after last treatment intake. No post-washout follow up
if patient continues on teriflunomide treatment by obtaining it's commercial form after
end of the study.
The total duration of the extension is 292 weeks (about 6 years) from the first patient
enrolled or until teriflunomide is commercially available in the country where patient
lives.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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