EFC10891 (HMR1726D - Teriflunomide) - Version 1.0, 27-Nov-2008

• Research type

  Research Study

• Full title

  A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis.

• IRAS ID

  31625

• Contact name

  John Zajicek

• Sponsor organisation

  sanofi-aventis

• Eudract number

  2008-006226-34

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT00883337

• Research summary

  The primary objective of this EFC10891 study is to see whether the 2 doses of tefluomide are effective when compared to Rebif© in treating Multiple Sclerosis(MS). 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. MS has a major physical, psychological, social and financial impact on patients and their families, and health-care organisations. Prognosis is uncertain and there is currently no cure although there are drugs available to help treat or manage many of the symptoms. Tefluomide is an oral medication and is thought to work through its effects on the immune system in helping to slow or prevent the symptoms related to MS and the inflammatory process underlying MS. It has been investigated in Phase II studies and currently being studied in phase III studies. It is hope that tefluomide will provide an important treatment choice for physicians and patients as it is an oral therapy while all currently available treatments are given by injection. Patients with relapsing forms of MS 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 consultant MS neurologists. Before the study starts, the study doctors will check that the patients are eligible and it is safe for them to take part. Patients will be randomised to to receive either tefluomide or Rebif© and they will be monitored closely during the study with blood tests and regular assessments. This study is expected to last from 16 months to approximately 3 years (including the screening, treatment and follow-up periods) depending on when all the patients have entered the study.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/135

• Date of REC Opinion

  3 Feb 2010

• REC opinion

  Further Information Favourable Opinion