EFC6058 (HMR1726-teriflunomide) - Version 2.0, 04-Oct-2010

• Research type

  Research Study

• Full title

  A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta

• IRAS ID

  66300

• Contact name

  David Rog

• Sponsor organisation

  sanofi-aventis Recherche et Developpement

• Eudract number

  2010-023172-12

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT00883337

• Research summary

  Multiple sclerosis (MS) is the most common disabling neurological disease among young adults affecting around 85,000 people in the UK. It is an inflammatory condition that damages the myelin (covering sheath) of the nerve fibres in the spinal cord and brain. Relapsing MS is a common form of MS that causes acute attacks of neurological dysfunction and disability. Prognosis is uncertain and there is currently no cure although there are drugs available to help treat or manage many of the symptoms. Interferon beta (IFN-Ç?) is a medication given by injection that has been used as first line disease-modifying drug in the treatment of relapsing multiple sclerosis (RMS) for more than a decade. However it is only partially effective at reducing relapses, as most patients continue to have clinical relapses even while under treatment. Some patients remain on IFN-Ç? since they perceive the treatment to be somewhat beneficial, even though it does not completely control disease activity. In these cases, the patients could benefit from having a tighter control on their disease, and one option is to use an additional therapy to improve effectiveness. Tefluomide is an oral medication that helps prevent the activation and proliferation of the white blood cells involved in the inflammatory process underlying MS. Therefore, the purpose of this study is to assess the effectiveness and safety of 7 mg and 14 mg of tefluomide compared to placebo in patients with relapsing MS who are already being treated with IFN-Ç?. This study is therefore designed to see whether tefluomide has an effect on the frequency of relapses in people with RMS. Patients with RMS who have provided a signed informed consent are eligible to take part in this study. This study will be conducted in selected specialist neurological centres under the supervision of MS neurologists.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/H0707/6

• Date of REC Opinion

  14 Mar 2011

• REC opinion

  Further Information Favourable Opinion