TERIS
Multi-center, randomized, double-blinded study of Teriflunomide® in radiologically isolated syndrome (RIS)Purpose: To prospectively study the efficacy of Teriflunomide in extending the time to a seminal acute or progressive demyelinating event in a cohort of RIS subjects.
Rationale: RIS subjects are frequently exposed to disease modifying therapies despite the lack of scientific literature supporting the use of such treatments. Earlier treatment intervention may extend the time to the first acute or progressive clinical event resulting from CNS demyelination and reduce radiological progression. In addition, early treatment may result in more profound effects on reducing disability progression long-term.
Primary outcome: The primary outcome measure for this trial is the time to the first acute or progressive neurological event resulting from CNS demyelination.
Population: This study will include RIS subjects from the Europe who fulfill 2009 RIS Criteria.
Population: adult | Intervention type: therapeutic medicinal product