Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta
Status:
Terminated
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
The primary objective was to demonstrate the effect of teriflunomide, in comparison to
placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of
MS who are treated with Interferon-beta (IFN-beta).
The secondary objectives were:
- Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on:
- Disease activity as measured by brain Magnetic Resonance Imaging (MRI)
- Disability progression
- Burden of disease and disease progression as measured by brain MRI
- Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy
- Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta
therapy
- Assess associations between variations in genes and clinical outcomes (safety and
efficacy)
- Assess other measures of efficacy of teriflunomide such as fatigue and health-related
quality of life
- Assess measures of health economics (hospitalization due to relapse, including the
length of stay and any admission to intensive care unit)