RecruitingPhase 4ACTRN12621000173897

A study to assess the efficacy of tofacitinib for the treatment of chronic pouchitis in adults

STOPit: Study of TOfacitinib for the treatment of chronic PouchITis


Sponsor

Pfizer Australia

Enrollment

120 participants

Start Date

Jul 16, 2021

Study Type

Interventional

Conditions

Summary

Chronic pouchitis is a common complication after a restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). Although antibiotics have been the mainstay of treatment for acute pouchitis, a proportion of patients become antibiotic-dependent or develop antibiotic-refractory pouchitis. There are few effective therapeutic options for these patients, and few prospective trials assessing their effectiveness. Tofacitinib was recently approved by Therapeutic Goods Administration (TGA) for treatment of ulcerative colitis (UC). It was found to be effective for induction and maintenance therapy in patients with moderate to severe UC. Chronic pouchitis is associated with similar inflammatory pathway activation as UC, therefore this study aims to investigate whether tofacitinib is effective for the treatment of chronic pouchitis.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Some people with ulcerative colitis undergo surgery to remove the large intestine, with a new internal pouch constructed from the small intestine — called an ileal pouch-anal anastomosis (IPAA). This surgery can restore close-to-normal bowel function, but a common complication is pouchitis — inflammation of the pouch that causes diarrhoea, urgency, and discomfort. While antibiotics usually help, a significant number of people develop ongoing (chronic) pouchitis that doesn't respond to antibiotics. This trial is testing whether tofacitinib — a medication already approved for ulcerative colitis — is effective for treating antibiotic-resistant or antibiotic-dependent chronic pouchitis. Tofacitinib works by blocking specific inflammation-driving signals in immune cells, and since the inflammation in chronic pouchitis resembles that of ulcerative colitis, it may work similarly. Adults aged 18–65 with a previous ulcerative colitis diagnosis who have had an IPAA pouch surgery, and who experience chronic or recurrent pouchitis requiring more than 4 weeks of antibiotics in the past year (or pouchitis not responding to antibiotics), may be eligible. Significant heart disease risk, kidney impairment, active infections, or a history of certain immune conditions may disqualify you. Tofacitinib tablets are taken daily for the treatment period.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

An open label induction with randomized, double blind, placebo-controlled withdrawal trial The study comprises two phases: An 8-week induction phase, with optional 8-week extension for non-responde

An open label induction with randomized, double blind, placebo-controlled withdrawal trial The study comprises two phases: An 8-week induction phase, with optional 8-week extension for non-responders, followed by a 24-week maintenance phase. During the induction phase, all participants will receive oral tablets of tofacitinib 10mg twice daily dosing for 8 weeks. At the end of induction, non-responders will proceed to extended induction, receiving another 8 weeks of tofacitinib 10mg twice daily dosing. Responders to standard or extended induction will proceed to randomization (1:1 allocation), to either oral tofacitinib 5mg twice daily or placebo (identical appearing oral tablet BD) during maintenance phase. The non-responders at the end of extended induction phase will discontinue from study. Any participants who experience a flare of symptoms would proceed to the open label extension study for 12 weeks, receiving either 5mg or 10mg twice daily dosing of tofacitinib, at the treating physician’s discretion. A total of 5 study visits are planned during the follow up period, including 3 pouchoscopies to assess pouch inflammation. At each of the study visits, there are several measurement tools involved, including study visit review, blood and stool tests, as well as questionnaires


Locations(15)

Mater Hospital Brisbane - South Brisbane

NSW,QLD,SA,WA,VIC, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD,SA,WA,VIC, Australia

The Alfred - Melbourne

NSW,QLD,SA,WA,VIC, Australia

Austin Health - Austin Hospital - Heidelberg

NSW,QLD,SA,WA,VIC, Australia

Liverpool Hospital - Liverpool

NSW,QLD,SA,WA,VIC, Australia

The Queen Elizabeth Hospital - Woodville

NSW,QLD,SA,WA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,QLD,SA,WA,VIC, Australia

Macquarie University Hospital - Macquarie Park

NSW,QLD,SA,WA,VIC, Australia

Gold Coast University Hospital - Southport

NSW,QLD,SA,WA,VIC, Australia

Fiona Stanley Hospital - Murdoch

NSW,QLD,SA,WA,VIC, Australia

Sunshine Coast University Hospital - Birtinya

NSW,QLD,SA,WA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,SA,WA,VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

NSW,QLD,SA,WA,VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

NSW,QLD,SA,WA,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,QLD,SA,WA,VIC, Australia

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ACTRN12621000173897


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