Health Condition 1: K633- Ulcer of intestine
Conditions
Interventions
Intervention1: Tofacitinib Enema: The intervention group will be given Tofacitinib enema for their treatment. Each enema contains 10 mg of tofacitinib dissolved in 20 cc of water and is applied rectal
Sponsors
All India Institute of Medical Sciences New Delhi Delhi
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving clinical response - SCCAI less than 3Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical remission at 8 weeks, SCCAI of less than 2 points. Endoscopic response & remission at 8 weeks defined as decline in UCEIS by 2 points & UCEIS of less than 1 points respectively. Deep remission at 8 weeks defined as a combination of clinical & endoscopic remission. Biochemical remission at 8 weeks defined as fecal calprotectin less than 150 ? g per g of stool Histological remission at 8 weeks defined as Nancy score of 0. Adverse events at 8 weeks. Relapse rate at 8 weeks - an increase of SCCAI more than or equal to 3 from baseline Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactMridul Mahajan
AIIMS New Delhi
Outcome results
None listed