The primary objective was to determine the effect of teriflunomide on the frequency of
relapses in patients with relapsing multiple sclerosis (MS).
Secondary objectives were:
- to evaluate the effect of teriflunomide on the accumulation of disability as measured
by Expanded Disability Status Scale [EDSS], the burden of disease as measured by
Magnetic Resonance Imaging [MRI] and patient-reported fatigue;
- to evaluate the safety and tolerability of teriflunomide.
The study period per participant was approximatively 128 weeks broken down as follows:
- Screening period up to 4 weeks,
- 108-week double-blind treatment period (approximatively 2 years)*,
- 16-week post-treatment elimination follow-up period.
'*' Participants successfully completing the week 108 visit were offered the opportunity to
enter the optional long-term extension study LTS6050 - NCT00803049.
- Multiple sclerosis [MS] subject who was ambulatory (EDSS of ≤ 5.5)
- Exhibiting a relapsing clinical course, with or without progression (relapsing
remitting, secondary progressive or progressive relapsing);
- Meeting McDonald's criteria for MS diagnosis;
- Experienced at least 1 relapse over the 1 year preceding the trial or at least 2
relapses over the 2 years preceding the trial;
- No relapse onset in the preceding 60 days prior to randomization;
- Clinically stable during the 30 days prior to randomization, without
adrenocorticotrophic hormone [ACTH] or systemic steroid treatment.
- Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
- Significantly impaired bone marrow function;
- Pregnant or nursing woman;
- Alcohol or drug abuse;
- Use of cladribine, mitoxantrone, or other immunosuppressant agents such as
azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before
- Any known condition or circumstance that would prevent in the investigator's opinion
compliance or completion of the study;