Tofacitinib plus corticosteroids for treatment of acute severe ulcerative colitis: a randomized controlled trial
- Conditions
- Health Condition 1: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2022/11/047186
- Lead Sponsor
- AIIMS Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment failure at day 6 defined as failure to achieve Lichtiger score reduction by â?¥3 points and overall score 10 at end of 5 days of therapy or requirement for colectomy within 5 days of therapyTimepoint: 6 days
- Secondary Outcome Measures
Name Time Method