Effect of Tofacitinib enema in improving disease activity in Ulcerative Colitis

Phase 3

Conditions: Health Condition 1: K633- Ulcer of intestine

Registration Number: CTRI/2024/08/071795

Lead Sponsor: All India Institute of Medical Sciences New Delhi Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Adult patients over 18 years of age.

UC diagnosed more than 3 months back based on international criteria- clinical, endoscopic, histologic, and radiologic features

Mild to moderate UC with ongoing disease activity - SCCAI 3-11, UCEIS more than 2

Proctitis or proctosigmoiditis can extend up to 25 cm from the anal margin.

Patients who were resistant or were unable to tolerate oral or rectal mesalamine and/or steroids.

Rectal therapy can be continued up to the day before the rectal tofacitinib study starts.

Patients who had been receiving oral mesalamine for 4 weeks had a stable dosage of 2.4 g per day for 2 weeks.

Patients on oral corticosteroids had taken them continuously for 4 weeks and were on a stable dose of 20 mg or less for 2 weeks before the screening visit.

Patients using azathioprine or 6-mercaptopurine or methotrexate had been on the medication for at least 12 weeks, with a stable dose for 4 weeks before the screening visit.

Exclusion Criteria

Patients experiencing hypersensitivity responses to oral or rectal tofacitinib.

Pregnant or lactating individuals

Patients taking anti-TNF-a medication or receiving a trial or biologic agent within eight weeks of the screening visit

Patients with drug or alcohol dependence, dementia, or inability to understand trial requirements

Patients with colitis that extends more than 25 cms from the anal verge

Patients with major diseases related to the liver, kidneys, endocrine system, respiratory system, nervous system, or cardiovascular system

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving clinical response - SCCAI less than 3Timepoint: 8 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical remission at 8 weeks, SCCAI of less than 2 points. <br/ ><br>Endoscopic response & remission at 8 weeks defined as decline in UCEIS by 2 points & UCEIS of less than 1 points respectively. <br/ ><br>Deep remission at 8 weeks defined as a combination of clinical & endoscopic remission. <br/ ><br>Biochemical remission at 8 weeks defined as fecal calprotectin less than 150 ? g per g of stool <br/ ><br>Histological remission at 8 weeks defined as Nancy score of 0. <br/ ><br>Adverse events at 8 weeks. <br/ ><br>Relapse rate at 8 weeks - an increase of SCCAI more than or equal to 3 from baseline <br/ ><br>Timepoint: 8 weeks