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

Phase 4

Recruiting

• Conditions: Chronic pouchitis; Inflammatory and Immune System - Autoimmune diseases; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12621000173897
• Lead Sponsor: Pfizer Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-18
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Adult patients age 18 to 65
2.Previous diagnosis of ulcerative colitis (UC) and have undergone total proctocolectomy and ileal pouch-anal anastomosis (IPAA)
3.Chronic or recurrent pouchitis that required > 4 weeks of antibiotics (CADP) in the previous 12 months OR pouchitis that is refractory to antibiotic therapy (CARP)
4.A total modified pouchitis disease activity index (mPDAI) score > 5 with endoscopic evidence of active disease
5.Completed pre-screening tests (blood test and chest x-ray) for tofacitinib therapy, including hepatitis B^, hepatitis C, human immunodeficiency virus, varicella zoster virus^, tuberculosis*, mumps^, measles^ and rubella^

^ Recommend pre-treatment vaccinations for hepatitis B, varicella zoster and mumps, measles, rubella if serology testing is negative.
* Individuals with latent tuberculosis should be treated with standard antimycobacterial therapy before administering tofacitinib.

Exclusion Criteria

1.Crohn’s disease of pouch (defined as the presence of stricture or fistula in the pouch)
2.IPAA surgery was performed for an indication other than ulcerative colitis such as familial adenomatous polyposis syndrome (FAP), hereditary nonpolyposis colorectal cancer, or Crohn’s disease (CD)
3.High cardiovascular risk factors (CHADS2 score > 2)
4.Bradycardia at baseline (<60 beats per minute), sick sinus syndrome, sinoatrial block, atrioventricular block
5.Chronic renal impairment (eGFR < 50mL/min)
6.Chronic liver disease (Child Pugh score B or C) or chronic hepatitis B
7.Active infections, including hepatitis B, hepatitis C, human immunodeficiency virus, varicella zoster virus, tuberculosis, mumps, measles and rubella
8.History of organ transplantation on immunosuppressive medications
9.Previous use of lymphocyte-depleting therapies (ie. alemtuzumab, cyclophosphamide, total lymphoid irradiation, rituximab, and any other lymphocyte depleting therapies)
10.History of unprovoked thromboembolism or hypercoagulable condition
11.Active or past malignancy (except non-melanoma skin cancer) or lymphoproliferative disorder
12.Significant lymphopenia (absolute lymphocyte count < 0.75x109cells/L), or neutropenia (absolute neutrophil count < 1.0 x109cells/L), or anaemia (hemoglobin < 80g/L)
13.Pregnancy or lactation
14.History of hypersensitivity or adverse events to other JAK inhibitor

Study & Design

• Study Type: Interventional
• Study Design: Not specified