Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.

Secondary objectives were:

• To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures.
• To investigate the pharmacokinetic and pharmacodynamic relationships.

The total duration of the study period per participants was 46 weeks comprising 3 periods:

• a 4-week screening period,
• a 36-week double-blind treatment period,
• a 6-week post-treatment follow-up period.

Participants who successfully completed the double-blind treatment phase were offered the possibility to continue study treatment in the extension study LTS6048 - NCT00228163.

Inclusion Criteria:

• Clinically confirmed multiple sclerosis [MS];
• Expanded Disability Status Scale [EDSS] score less or equal to 6;
• Two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
• Screening magnetic resonance imaging [MRI] scan fulfilling the criteria for a diagnosis of MS.

Exclusion Criteria:

• Clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease;
• Pregnant or nursing woman;
• Wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
• Prior treatment with interferon [IFN], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
• Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
• 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.