Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Teriflunomide; Placebo
Intervention description: Pharmaceutical form:film-coated tablet, Route of administration: oral; Pharmaceutical form:tablet, Route of administration: oral
Intervention MeSH terms: Teriflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 166.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To assess the effect of teriflunomide in comparison to placebo on disease activity measured
      by time to first clinical relapse after randomization in children and adolescents 10 to 17
      years of age with relapsing forms of multiple sclerosis (MS).

      Secondary Objective:

        -  To assess the effect of teriflunomide in comparison to placebo on disease
           activity/progression measured by brain magnetic resonance imaging (MRI) and on cognitive
           function.

        -  To evaluate the safety and tolerability of teriflunomide in comparison to placebo.

        -  To evaluate the pharmacokinetics (PK) of teriflunomide.
    

Eligibility criteria:

        -  Participants with relapsing MS were eligible. Participants who met the criteria of MS
             based on McDonald criteria 2010 and International Pediatric Multiple Sclerosis Study
             Group (IPMSSG) criteria for pediatric MS, version of 2012 and had:

               -  at least one relapse (or attack) in the 12 months preceding screening or,

               -  at least two relapses (or attack) in the 24 months preceding screening.

          -  Less than 18 years of age and greater than or equal to (>=) 10 years of age at
             randomization. Specific for the Russian Federation from 18 December 2014 to 26 July
             2016, less than or equal to 17 years of age and >= 13 years of age at randomization.

          -  Signed informed consent/assent obtained from participant and participant's legal
             representative (parents or guardians) according to local regulations.

        Exclusion criteria:

          -  Expanded disability status scale score greater than 5.5 at screening or randomization
             visits.

          -  Relapse within 30 days prior to randomization.

          -  Treated with:

               -  glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to
                  randomization.

               -  fingolimod, or intravenous immunoglobulins within 3 months prior to
                  randomization.

               -  natalizumab, other immunosuppressant or immunomodulatory agents such as
                  cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within
                  6 months prior to randomization.

               -  cladribine or mitoxantrone within 2 years prior to randomization.

          -  Treated with alemtuzumab at any time.

          -  History of human immunodeficiency virus infection.

          -  Contraindication for MRI.

          -  Pregnant or breast-feeding females or those who plan to become pregnant during the
             study.

          -  Female participants of child-bearing potential not using highly effective
             contraceptive method (contraception in both female and male was required).

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.