Teriflunomide Shows Consistent Clinical Efficacy On Severe Relapses Across temso and tower: 2 Phase 3 trials
نویسندگان
چکیده
منابع مشابه
A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses.
BACKGROUND Teriflunomide, a dihydro-orotate dehydrogenase inhibitor, has immunomodulatory effects, including the ability to suppress experimental allergic encephalomyelitis. In this randomized, double-blind, placebo-controlled Phase II study, the authors examined the safety and efficacy of oral teriflunomide in multiple sclerosis (MS) with relapses. METHODS Patients (n = 179) with relapsing-r...
متن کاملLong-term safety and efficacy of teriflunomide: Nine-year follow-up of the randomized TEMSO study.
OBJECTIVE To report safety and efficacy outcomes from up to 9 years of treatment with teriflunomide in an extension (NCT00803049) of the pivotal phase 3 Teriflunomide Multiple Sclerosis Oral (TEMSO) trial (NCT00134563). METHODS A total of 742 patients entered the extension. Teriflunomide-treated patients continued the original dose; those previously receiving placebo were randomized 1:1 to te...
متن کاملOral teriflunomide in the treatment of relapsing forms of multiple sclerosis: clinical evidence and long-term experience
Key objectives in the treatment of multiple sclerosis (MS) include prevention of relapses, a reduction in the accumulation of disability and slowing of the brain volume loss that occurs from the earliest stages of the disease. Teriflunomide, a once-daily, oral immunomodulatory therapy, has demonstrated efficacy across multiple measures of disease activity and worsening in patients with relapsin...
متن کاملTeriflunomide for the treatment of multiple sclerosis.
Teriflunomide is a new active drug which has recently been approved as a first-line treatment of relapsing forms of MS in the US, Australia, Argentina, and the European Union. It is characterized by a once-daily oral application and a well-established long-term safety profile. The main therapeutic effect is considered to be mediated via the inhibition of the de novo synthesis of pyrimidine in p...
متن کاملDiscounting phase 2 results when planning phase 3 clinical trials.
Sample size planning is an important design consideration for a phase 3 trial. In this paper, we consider how to improve this planning when using data from phase 2 trials. We use an approach based on the concept of assurance. We consider adjusting phase 2 results because of two possible sources of bias. The first source arises from selecting compounds with pre-specified favourable phase 2 resul...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Value in Health
سال: 2015
ISSN: 1098-3015
DOI: 10.1016/j.jval.2015.03.1631