Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients

The total duration of the study per patient is up to 50 or 54 weeks (if accelerated
elimination procedure performed):

Screening: up to 2 weeks Teriflunomide treatment: 48 weeks Accelerated elimination
procedure: 4 weeks when performed)

An accelerated elimination procedure at any time after discontinuation of teriflunomide
treatment is possible and it is particularly recommended for women of child-bearing
potential.

Inclusion criteria:

Patients with a relapsing form of multiple sclerosis (RMS) Having signed written informed
consent

Exclusion criteria:

- ACCORDING TO LOCAL LABELING

- Less than 18 years of age

- Current or history of receiving teriflunomide

- Previous treatment with leflunomide within 6 months prior to baseline

- Patients 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

- Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS),
bone marrow disease, acute or severe active infections

- Women who are pregnant or breast-feeding

- Female patients with a positive pregnancy test at screening or women of child-bearing
potential who do not agree to use reliable contraception throughout the course of the
study

- Male patients (only when required according to local labeling): unwilling to use
reliable contraception during the course of the study

- Additional exclusion criteria applicable for EU countries (in accordance with
contraindications of EU SmPC):

- Patients with significantly impaired bone marrow function or significant
anaemia, leukopenia, neutropenia or thrombocytopenia

- Patients with severe active infection until resolution

- Patients with severe renal impairment undergoing dialysis, because insufficient
clinical experience is available in this patient group

- Patients 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 patient's potential
participation in a clinical trial.