Conditions: Multiple Sclerosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1001
Healthy volunteers: no

Brief 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.

Detailed description:
The total duration of the study per participant was 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 was possible and it was particularly recommended for women of child-bearing potential.

Arms:
arm 1: Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.

Interventions: intervention 1: Teriflunomide
Intervention descriptions: intervention 1: Pharmaceutical form: film-coated tablet; Route of administration: oral

Protocol document: