Adalimumab (HUMIRA®) use in patients with Ulcerative Colitis
Research type
Research Study
Full title
An observational multi-centre retrospective research study to describe the real world use of adalimumab in UK patients with ulcerative colitis
IRAS ID
168501
Contact name
Gill Watts
Contact email
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
While adalimumab is not currently considered by The National Institute for Health and Care Excellence (NICE) to be cost effective for ulcerative colitis (UC) treatment, its efficacy in achieving steroid-free remission and mucosal healing means that clinicians are prescribing it for some patients with moderate to severe UC. It would seem therefore that adalimumab has its place in the toolkit for the treatment of UC and indeed NICE is in the process of conducting a Multiple Technology Assessment (MTA) on 3 licensed anti-TNF therapies (including adalimumab) for use in moderate to severe UC.
The primary objective of this retrospective observational study is to describe the patient population that are prescribed adalimumab, via individual funding requests, to better understand the demographic, disease severity, prior treatment history and prior resource use of these patients with moderate to severe UC. The study will also evaluate response to treatment and where possible the impact that the treatment has on a patient's quality of life. It is hoped that this data may help suitable patients’ access adalimumab in the future.
Patients who have had UC for at least 12 months, who have been prescribed adalimumab by their consultant gastroenterologist in secondary care clinics will be asked to consent to allow their medical records to be reviewed for this study. There will be no change to their treatment as a result of taking part in this research. Fifty patients from 4-5 hospitals will be recruited to the study and it is expected that the retrospective note review will be completed by spring 2015.REC name
London - City & East Research Ethics Committee
REC reference
14/LO/2167
Date of REC Opinion
29 Nov 2014
REC opinion
Favourable Opinion