Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: teriflunomide; Interferon-β-1; Influenza vaccine
Intervention description: Film-coated tablet
Oral administration; Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection; Inactivated, split-virion influenza vaccine 2011-2012
One administration by intramuscular or intradermal route as per product specification
Intervention MeSH terms: Interferons; Interferon-beta; Teriflunomide; Interferon beta-1b
Phase: Phase 2
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      Assess the antibody response to influenza vaccine in patients with relapsing form of multiple
      sclerosis (RMS) treated with teriflunomide compared to a reference population.

      Secondary Objectives:

        -  Assess the effect of teriflunomide on immunoglobulin levels;

        -  Assess the safety of influenza vaccination in patients with RMS treated with
           teriflunomide.

      The reference population was defined as multiple sclerosis (MS) patients with a stable
      treatment with interferon-β-1. Antibody response was measured using hemagglutination
      inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1,
      and B as present in the influenza vaccine used.
    

Eligibility criteria:

        Inclusion Criteria:

        - Male or female patient <60 years old with relapsing multiple sclerosis (RMS) either
        treated for at least 6 months with 7 or 14 mg teriflunomide in one of the studies LTS6048
        or LTS6050, or treated with a stable dose of interferon-β-1 for at least 6 months.

        Exclusion Criteria:

          -  Concomitant infectious pathology at the time of vaccination;

          -  MS relapse within 1 month before vaccination;

          -  Systemic corticosteroids within 1 month before the vaccination;

          -  Any contraindication to influenza vaccine;

          -  Any vaccination within the last 6 months;

          -  Prior use of any investigational drug or participation to a clinical trial within 1
             year (only for patients under interferon-β-1);

          -  Prior or concomitant use (for a minimum of 1 year before study entry) of cladribine,
             mitoxantrone, or other immunosuppressant agents such as azathioprine,
             cyclophosphamide, cyclosporin, methotrexate, mycophenolate, natalizumab (Tysabri®),
             leflunomide or fingolimod or other immunomodulator/immunosuppressant in development;

          -  Prior or concomitant use of glatiramer acetate within 1 year before study entry;

          -  Prior or concomitant use of intravenous immunoglobulins within 3 months before study
             entry;

          -  Pregnant or breast feeding women;

          -  Woman of childbearing potential without adequate contraception.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.