Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Teriflunomide
Intervention description: Pharmaceutical form: film-coated tablet; Route of administration: oral
Intervention MeSH terms: Teriflunomide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1001.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To describe efficacy, tolerability and convenience of teriflunomide treatment through the
      evaluation of Participant Reported Outcomes (PROs).

      Secondary Objectives:

      To describe disease progression using PROs. To describe clinical outcomes (ie, treated
      relapses) in teriflunomide treated participant.

      To describe the change in cognition in teriflunomide treated participants. To describe safety
      of teriflunomide in participant treated (based on adverse events reporting).

      To describe adherence and persistence to teriflunomide treatment. To describe quality of
      life, activity and leisure over the period of teriflunomide treatment.

      To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale
      (EDSS) in assessing Multiple Sclerosis (MS) disease progression.
    

Eligibility criteria:

        Inclusion criteria:

        Participants with a relapsing form of multiple sclerosis (RMS) having signed written
        informed consent.

        Exclusion criteria:

          -  According to local labelling,

          -  Less than 18 years of age,

          -  Current or history of receiving teriflunomide,

          -  Previous treatment with leflunomide within 6 months prior to baseline,

          -  Participants with preexisting acute or chronic liver disease, or those with serum
             alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN),

          -  Known history of active tuberculosis (TB) or latent TB infection, either diagnosed by
             standard medical practice or guidelines (including skin or blood test, chest X-ray, or
             as appropriate per local practice),

          -  Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS),
             bone marrow disease, acute or severe active infections,

          -  Women who were pregnant or breast-feeding,

          -  Female participants with a positive pregnancy test at screening or women of
             child-bearing potential who did not agree to use reliable contraception throughout the
             course of the study,

          -  Male participants (only when required according to local labeling): unwilling to use
             reliable contraception during the course of the study,

          -  Additional exclusion criteria applicable for Europe (EU) countries (in accordance with
             contraindications of EU summary of product characteristics [SmPC]):

               -  Participants with significantly impaired bone marrow function or significant
                  anaemia, leukopenia, neutropenia or thrombocytopenia,

               -  Participants with severe active infection until resolution,

               -  Participants with severe renal impairment undergoing dialysis, because
                  insufficient clinical experience was available in this participant group,

               -  Participants with severe hypoproteinaemia, e.g. in nephrotic syndrome.

          -  Hypersensitivity to the active substance or to any of the excipients,

          -  Other additional contraindications per local labeling.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.