Retrospective Observational Study (EFFECT) 109MS421

• Research type

  Research Study

• Full title

  A multicenter, global, retrospective, observational study to characterize real-world clinical outcomes in patients with relapsing-remitting multiple sclerosis treated with disease-modifying therapies(Tecfidera®, Copaxone®, Aubagio®, or Gilenya®) (EFFECT)

• IRAS ID

  203593

• Contact name

  Sarah Tissington

• Contact email

  sarah.tissington@biogen.com

• Sponsor organisation

  Biogen Idec Research Limited

• Clinicaltrials.gov Identifier

  NCT02776072

• Duration of Study in the UK

  0 years, 10 months, 27 days

• Research summary

  This is a retrospective observational research study in patients that have been prescribed one of the following four medicines: Tecfidera®, Copaxone®, Aubagio®, and Gilenya®. These medications are known as Disease Modifying Therapies (DMTs) and are approved for patients with Relapsing-Remitting Multiple Sclerosis (RRMS). This type of multiple sclerosis involves episodes of relapse and remission.
  An observational, retrospective study is a study where data is reviewed and collected about patients as part of their normal medical treatment that was recorded in the past.

  The purpose of this study is to find out how effective these medicines are in patients with RRMS. The study will be conducted through the review of medical records of patients treated with these approved drugs (index therapy). The patients do not need to come to the clinic for any visits as this study will only involve the review of the patients’ medical notes for specific information related to their illness and treatment.
  In order for patients to be included in this study, the patients must have started treatment no earlier than January 2011 and no later than 12 months before the date their medical records are reviewed. No drug administration, study procedures or patient visits will be required.

  There are no benefits for patients participating in this study. However, the information collected in this study may help Biogen understand RRMS and DMTs, which might help people with a similar condition in the future.

  The study is sponsored by Biogen research limited and will be conducted in approximately 17 countries across the world including in the UK.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  16/SW/0230

• Date of REC Opinion

  29 Sep 2016

• REC opinion

  Further Information Favourable Opinion