A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Interferon β-1a; Teriflunomide
Intervention description: Sterile preservative-free solution packaged in graduated pre-filled syringes
Subcutaneous injection
Ascending doses from 8.8 to 44 mcg according to local standard for Rebif®; Film-coated tablet
Oral administration
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Teriflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 324.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsing-remitting multiple sclerosis

Summary:

      Primary objective was to assess the effectiveness evaluated by the time to failure of two
      doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing
      Multiple Sclerosis [MS].

      Secondary objectives were:

        -  To assess the effect of the two doses in comparison to interferon beta-1a on:

             -  Frequency of relapses,

             -  Fatigue,

             -  Participant's satisfaction with treatment.

        -  To evaluate the safety and tolerability of the two doses in comparison to interferon
           beta-1a.

      The study consisted of a core treatment period with a common end date defined as 48 weeks
      after randomization of the last participant, followed by an optional long-term extension
      treatment period until teriflunomide is commercially available in accordance with local
      regulations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsing form of MS meeting McDonald's criteria for MS diagnosis and Expanded
             Disability Status Scale [EDSS] score ≤5.5 at screening visit.

        Exclusion Criteria:

          -  Significantly impaired bone marrow function or, significant anemia, leukopenia or
             thrombocytopenia;

          -  Persistent significant or severe infection.

          -  Liver function impairment or known history of hepatitis.

          -  Use of adrenocorticotrophic hormone [ACTH] or systemic corticosteroids for 2 weeks
             prior to randomization.

          -  Human immunodeficiency virus [HIV] positive.

          -  Prior use of Rebif®, or prior or concomitant use of other interferons in the 3 months
             prior to randomization.

          -  Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant
             agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate,
             mycophenolate, or natalizumab.

          -  Pregnant or breast-feeding woman.

        Extension criteria:

        The participants who met all the following criteria at the end of the core study period
        were eligible for enrolment into the open-label extension phase:

          -  Participants who had not discontinued treatment in the core period and who had a
             minimum treatment of 48 weeks and completed the EOT visit (Visit 18).

          -  Participants who had not met criteria for treatment withdrawal.

          -  An informed consent must be obtained in writing from the participant for this
             open-label extension phase prior to entering and prior to completion of any extension
             phase procedure.

          -  Participants who demonstrated a willingness and ability to roll over to the extension
             phase with the opportunity to continue treatment on 14 mg/day of teriflunomide under
             open-label.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.