NATURAL HISTORY OF IBD IN CARDIFF 1986-2015
Research type
Research Study
Full title
The impact of thiopurine and anti-tumour necrosis factor therapy on the natural history of Inflammatory Bowel Disease in a population-based cohort diagnosed in Cardiff 1986-2015
IRAS ID
275200
Contact name
Antony B. Hawthorne
Contact email
Sponsor organisation
Research and Development Dept
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
Inflammatory bowel diseases (Crohn’s disease and ulcerative colitis) occur in young people, causing pain, diarrhoea and other symptoms over many years, due to inflammation in the gut. A number of drug treatments which suppress the immune system have been shown to be effective in clinical trials over 1-2 years. It is hoped that early use of these drugs may reduce the chance of severe gut damage needing surgical resection of affected bowel, but there are few trials with long enough follow-up to show this. We aim to look at all IBD patients diagnosed in the City of Cardiff, over a 30 year period, to see whether treatment with azathioprine or mercaptopurine, or anti-TNF drugs, results in a lower chance of needing surgery over 5 years or longer after diagnosis. We will look particularly at patients treated within one year of diagnosis, and those treated at any time after diagnosis. Because we will follow ALL patients diagnosed in Cardiff we will include all types and severities of disease. Patients receiving these early treatments will be matched to those not receiving early treatment, who have similar risk factors for severe disease (this is called the propensity score method) so as not to introduce bias between the treated and the control group. The results will tell us whether real-world use of these drugs improves long-term outcomes for IBD patients. The study will measure disease incidence in Cardiff, and also evaluate the impact of different disease characteristics, and other treatments received on likelihood of surgery, death or severe adverse effects (eg cancer or infections)
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0064
Date of REC Opinion
28 Feb 2020
REC opinion
Favourable Opinion