Study to assess treatment of UC with Cortiment in routine practice

• Research type

  Research Study

• Full title

  A prospective multi-centre observational cohort study assessing the effectiveness of Cortiment® for the treatment of mild-to-moderate active ulcerative colitis in routine clinical practice

• IRAS ID

  196794

• Contact name

  Andreas Diedenhofen

• Contact email

  andreas.diedenhofen@ferring.com

• Sponsor organisation

  Ferring International Ltd

• Duration of Study in the UK

  0 years, 6 months, 30 days

• Research summary

  This is a multicentre, prospective, non interventional, international research study. This early clinical experience study is designed to assess the effectiveness of Cortiment® for treatment of ulcerative colitis (UC) in a real-life setting. Cortiment® is a controlled-release oral formulation of the corticosteroid budesonide, designed to deliver the drug throughout the colon. The study is taking place globally with 300 patients to be recruited in total.

  The study will be conducted in the gastroenterology departments of 4 secondary / tertiary care centres in the UK. Centres will be selected where Cortiment® is available for prescribing and where clinicians are known to be using Cortiment® in the management of adult patients with mild-to-moderate active UC.

  Potential study participants will be identified prospectively as they are initiated on Cortiment® in the course of routine clinical care in the participating centres and will be approached for consent to join the study.

  Consecutive eligible consenting patients enrolling in the study during the recruitment period (up to a maximum of 30 participants) will be included.
  Patients will be asked to complete quality of life and work productivity questionnaires at 2 different time points; baseline (ie within 3 days of Cortiment® initiation), and up to 2 weeks after the last dose of Cortiment®. They will also be asked to complete a patient diary on a daily basis.

  The overall aim is to evaluate Cortiment® with regards to its use by clinicians in routine clinical practice, and its effectiveness and tolerability in a real-life setting in a population of patients with mild-to-moderate active ulcerative colitis.

• REC name

  South East Scotland REC 01

• REC reference

  16/SS/0039

• Date of REC Opinion

  5 Feb 2016

• REC opinion

  Favourable Opinion