OPTIMUM
Research type
Research Study
Full title
Multicentre, randomised, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis
IRAS ID
178822
Contact name
Marjolaine Phan
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Eudract number
2012-000540-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 0 days
Research summary
This is a medical research study investigating the study drug, ponesimod, an experimental drug that is being tested for patients with relapsing multiple sclerosis (RMS) in comparison with an approved medication called teriflunomide
Experimental means that ponesimod, the study drug is not yet approved for use.
Multiple Sclerois (MS) affects an estimated 202.5 million people worldwide, of whom approximately 630,000 are in Europe and 250,000 to 350,000 in the United States.
The incidence of MS is about 7 cases per 100,000 persons per year. The prevalence rate varies between races and geographical latitudes, ranging from 50 to 120 per 100,000.
MS is the most common chronic neurologic disease in adults between 20 and 50 years of age with a peak onset of MS in the early thirties. Women are affected approximately twice as often as men. In 2 to 5% of patients, disease presents before the age of 16.
This study is designed to compare the efficacy, safety, and tolerability of ponesimod 20 mg vs teriflunomide 14 mg in adult subjects with relapsing forms of MS.
The main objective of this research study is to determine whether ponesimod is more efficacious than teriflunomide in terms of reducing relapses in subjects with relapsing multiple sclerosis (RMS).
Other aims include:
1) Evaluation of ponesimod on disability accumulation and on other aspects of multiple sclerosis (MS) disease control.
2) Assessment of the safety and tolerability of ponesimod in subjects with RMS.
Approximately 1100 patients will be randomised to take part in this study, in the UK and worldwide.
The study comprises of pre-randomisation: (screening and baseline), treatment, end of treatment, post-treatment safety follow-up.
A patient information sheet describing the study will be provided.
Participation in this study is entirely voluntary. Signed and dated informed consent will be obtained from each participant before any study procedures are performed.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0277
Date of REC Opinion
30 Sep 2015
REC opinion
Further Information Favourable Opinion