Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
Completed
Sanofi
Phase 3
2004-09-01
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.
Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
Completed
Sanofi
Phase 2
2002-01-01
The primary objective is to assess the long-term safety of teriflunomide in multiple
sclerosis subjects. The secondary objective is to assess the long-term efficacy.
Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis
Completed
Sanofi
Phase 2
2007-04-01
The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide
administered once daily for 24 weeks, compared to placebo, in patients with multiple
sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA].
The secondary objectives were:
- to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in
combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters,
relapse rate and patient-reported fatigue;
- to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with
a stable dose of GA.
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