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Study of Tofacitinib for the treatment of chronic PouchITis
The clinical trial for people with long term inflammation of the pouch!
Long-term inflammation of pouch after a colon removal surgery, termed chronic pouchitis, in people with ulcerative colitis, is a common and frequently incapacitating condition. Pouchitis that either does not improve despite antibiotic treatment or requires extended courses of antibiotics often requires long term medical therapy. Unfortunately, there is limited treatment option for people with chronic pouchitis.
The STOPit trial is an Australian-wide study to assess the effectiveness of tofacitinib for treatment of chronic pouchitis. In this trial all participants receive standard induction dose tofacinitib in the first two to four months. Following these participants who respond are randomly assigned to receive either standard dos tofacitinib or a sugar pill (placebo). This trial has the potential to address the lack of treatment option for chronic pouchitis and to provide a better quality of life to people with this debilitating condition.
The trial is being led by experts from Mater Hospital Brisbane, with multiple participating hospitals nationwide. People who are 18 to 65 years old, with a previous diagnosis of ulcerative colitis and who have undergone colon removal surgery and pouch formation, and who has evidence of chronic pouchitis, may be eligible to participate.
People who are interested in the trial can discuss it with their treating gastroenterologist for a referral to STOPit at [email protected]
Participant sites include:
1. Mater Brisbane Hospital (the coordinating center)
2. Princess Alexandra Hospital, QLD
3. Royal Brisbane and Women Hospital, QLD
4. Sunshine Coast University Hospital, QLD
5. St Vincent Hospital, VIC
6. Alfred Hospital, VIC
7. The Austin Hospital, VIC
8. Liverpool Hospital, NSW
9. Queen Elizabeth Hospital, SA
10. Royal Adelaide Hospital, SA
11. Monash Health, VIC
12. Royal Prince Alfred Hospital, NSW
13. Macquarie University Hospital, NSW
14. Gold Coast University Hospital, QLD