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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: (T,G)-A-L; Glatiramer Acetate; Teriflunomide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.