Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00475865

Run by

Sanofi

People needed

123

Starts

2007-04-01

Expected to finish

2009-10-01

Last updated by the study team

2012-11-06

Who can join

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

You may qualify if…

• Definite MS diagnosis according to McDonald's criteria;
• Relapsing clinical course, with or without progression;
• Expanded Disability Status Scale [EDSS] less or equal to 5.5 (ambulatory);
• Stable dose of Glatiramer Acetate [GA] for at least 26 weeks prior to the screening visit;
• No onset of MS relapse in the preceding 60 days prior to randomization;
• Clinically stable for 4 weeks prior to randomization.

You may not qualify if…

• Other chronic disease of the immune system, liver function impairment or chronic pancreatic disease;
• 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;
• Human immunodeficiency virus [HIV] positive status;
• 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 patient's potential participation in a clinical trial.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Vienna, Austria
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — Guildford, United Kingdom

Full record on ClinicalTrials.gov

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