IBD-PODCAST: Inadequate Disease Control in IBD
Research type
Research Study
Full title
IBD-PODCAST United Kingdom Proportion of Inadequate Disease Control And Strategy of Treatment in Inflammatory Bowel Disease (IBD PODCAST)
IRAS ID
309682
Contact name
Ailsa Hart
Contact email
Sponsor organisation
Abbvie UK
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 6 months, 28 days
Research summary
This is an observational study. This study will be conducted at four sites (centres treating people with inflammatory bowel disease [IBD]) in the United Kingdom (UK).
Ulcerative Colitis (UC) and Crohn’s disease (CD) are inflammatory bowel diseases where parts of the digestive system become inflamed. There is a limitation in available treatment options. If IBD is not controlled well, it can have a negative impact on quality of life and day to day activities. The number of medical treatment options available to patients has increased in the last few years. Despite this, about 40% of patients show an inadequate response.
This research aims to quantify the percentage of patients with inadequate disease control in the IBD patient population in daily clinical practice, and better understand the associated impacts and disease burden.
This study comprises a retrospective review of patients' medical records, and cross-sectional physician and patient completed assessments. Patient completed assessments include questionnaires measuring quality of life, fatigue, work productivity, level of disease control, and IBD symptoms and impacts.
There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required. The enrolment period will be about 3 months.
The population for this study is adult patients diagnosed with Crohn's disease or Ulcerative Colitis. It is expected to recruit 200 patients in total: 100 with CD and 100 with UC.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0111
Date of REC Opinion
22 May 2022
REC opinion
Favourable Opinion