Dual therapy with Tofacitinib and corticosteroids versus corticosteroids for treatment of acute severe ulcerative colitis: a parallel, double blind, placebo-controlled, randomized trial - TOFA-ASUC

AIIMS Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年11月21日

试验速览

暂无简介。

•1.Age >=18 years
•2.Presentation consistent with acute severe ulcerative colitis and modified Truelove Wittâ??s criteria
•3.Consent obtained
•4.CT chest showing no evidence of active pulmonary infection, including tuberculosis

•1.IV steroid therapy for >= 48 hours prior to randomization
•2.Disease limited to rectum (proctitis, E1)
•3.Thromboembolism:
•a.Current or prior clinical or radiological evidence of deep venous thrombosis, pulmonary embolism, acute myocardial infarction, or stroke
•b.Atrial fibrillation
•4.Infection
•a.Active herpes zoster
•b.Current active tuberculosis or on anti-tubercular therapy for less than 4 weeks
•c.Active untreated extra-intestinal infection (such as abscess, pneumonia, urinary infection)
•5.Biological therapy
•a.Recent initiation or dose escalation of biological agent (anti-TNFa, anti-interleukin) within 8 weeks
•6.Tofacitinib use within 8 weeks prior to presentation
•7.Surgical indication in ASUC (including toxic megacolon or perforation)
•8.Pregnancy
•9.Serious organ impairment
•a.Cardiac: NYHA II or higher congestive heart failure
•b.Renal: Creatine clearance (Cockcroft Gault formula) <40 ml/min
•c.Hepatic: INR >2.5 or bilirubin >30

发起方

AIIMS Delhi