About TEMSO study
TEMSO was a two-year randomized, double-blind, placebo-controlled multinational study that included 1,088 people with relapsing forms of MS from 126 centers in 21 countries. Trial participants were 18-55 years of age, with an Expanded Disability Status Scale (EDSS) of 5.5 or less, and had at least one relapse in the previous year or at least two relapses in the preceding two years. Trial participants were randomized to placebo or teriflunomide, 7mg or 14mg, once daily and followed for 108 weeks. The primary endpoint was annualized relapse rate, defined as the number of confirmed relapses per trial participant year; a relapse is a new or worsening of a previous clinical sign or symptom. The key secondary endpoint was the time to sustained disability progression, measured by the EDSS. Disability progression was defined as an increase from baseline of at least 1.0 point on the EDSS persisting for at least 12 weeks. Change from baseline in total lesion volume was also a key prespecified MRI endpoint in the study. Safety and tolerability evaluations were based on adverse events, physical examinations, vital signs and laboratory investigations. A long-term extension of TEMSO is ongoing.
Teriflunomide is an immunomodulatory, disease-modifying oral drug with anti-inflammatory properties, and is under investigation for the treatment of relapsing forms of MS. Teriflunomide blocks the proliferation and functioning of activated T and B lymphocytes - which are thought to be especially damaging in MS - by selectively and reversibly inhibiting a critical mitochondrial enzyme. With nine years of continuous use in a Phase II extension, teriflunomide has the longest clinical experience of any investigational oral MS therapy. In addition to the TEMSO trial, two other Phase III trials, TOWER and TENERE, are ongoing in people with RMS. A Phase III study, TOPIC, is also underway
Copyright©2010 PR Newswire.
All rights reserved