Real life experience of Vedolizumab in UK

• Research type

  Research Study

• Full title

  Real life experience of Vedolizumab for IBD in tertiary referral centres accross the UK

• IRAS ID

  190071

• Contact name

  Nikolaos Kamperidis

• Contact email

  nkamperidis@yahoo.com

• Sponsor organisation

  London North West Healthcare NHS Trust

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Inflammatory Bowel Disease comprises two conditions: Ulcerative Colitis and Crohn's disease. Both manifest in a relapsing/remitting pattern and can cause significant morbidity, disturbance in patients' quality of life and costs to the healthcare system. Vedolizumab is a newly licensed drug for the treatment of Inflammatory Bowel Disease. It works by blocking the migration of inflammatory cells to the gut and it can be successful in improving the disease activity in up to 50% of patients according to the published clinical trials. Also, according to the same publications, its side effect profile is very favorable.
  However, there are no studies published so far describing its effectiveness in the real life setting and no studies informing on its impact on surgical outcomes.
  Therefore, as this drug is newly licensed for use in the UK, we devised a study to describe its effectiveness and safety in the real life setting and to document the surgical complications rate among patients who undergo surgery after receiving treatment with the drug and the possible implications of pre-surgical drug levels in surgical outcomes. This is going to help optimise the use of the drug in the day by day clinical setting and also the patient selection process prior to undertaking surgery

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  16/LO/0172

• Date of REC Opinion

  19 Jan 2016

• REC opinion

  Favourable Opinion