Efficacy of Tofacitinib Enema in Inducing Remission in Patients with Mild toModerate Resistant Ulcerative Proctosigmoiditis A Double-Blind RandomizedPlacebo-Controlled Trial - NI

All India Institute of Medical Sciences New Delhi Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•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.

•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

发起方

All India Institute of Medical Sciences New Delhi Delhi