|NHS Trial of infliximab and ciclosporin
19 Sept 08
Drugs for acute severe UC assessed
The National Institute for Health Research Health Technology Assessment (NIHR HTA) programme has funded a £1.6 million clinical trial to compare two powerful drugs for people with steroid resistant acute severe ulcerative colitis (UC). UC affects approximately 150,000 people in the UK and is a major burden on patients and NHS resources, as it often leads to severe morbidity, grossly impaired quality of life, frequent and long inpatients stays and emergency colectomy.
Recent studies have reported that infliximab and ciclosporin are effective in treating patients with chronic UC resistant to oral steroids, but there is a lack of evidence in acutely ill patients. NICE have recently highlighted the need for a large, high-quality trial to address in particular the long-term impact on patient outcomes, and costs. Researchers led by Professor John G Williams of Swansea University will use a two arm trial to compare the clinical and cost-effectiveness of infliximab and ciclosporin over a ten year period. They aim to recruit around 480 patients across 40 centres in the UK to assess and compare quality of life, death rates, colectomy, severe illness, NHS and patient borne costs, and patient views after these treatments.
“UC is a chronic debilitating disease and is one of the most important conditions seen by gastroenterologists. Acutely ill patients who do not respond to steroid treatment usually require surgical removal of the large bowel.” says Professor Williams. “Few alternative treatments exist for severe steroid-resistant UC, so it is important that this research is conducted to help identify whether infliximab and ciclosporin are cost-effective options with proven benefits for this group of patients.”
|Mind/Body Medicine and IBD Flare-Up
•Have moderately severe Ulcerative Colitis in remission (flare-up in the past 6 months)
• Have no history of colon resection
•Not be pregnant
Clinical Research Study Coordinator
Rush University Medical Center
Section of Gastroenterology
1725 W. Harrison Street, Suite 206
Chicago, IL 60612