Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Tofacitinib: Oral JAK inhibitor.
Route: per oral
Dose: 10 mg TDS for 3 days (i.e. first 9 doses) followed by 10 mg BD for next 2 days
Duration (within trial): 5 days
Control Intervent
Sponsors
AIIMS Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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) c. Hepatic: INR >2.5 or bilirubin >30
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Clinical relapse between day 6 and 90: defined as increase in Lichtiger score by 3 points and total score â?¥ 10Timepoint: 6 to 90 days;Difference in baseline ultrasound parameters between responders and non-responders: sigmoid colon wall thickness (mm), pericolic fat thickness (mm), and doppler grading of vascularity as measured by trans-abdominal ultrasoundTimepoint: 6 days;Difference in baseline Visceral fat area (VFA), subcutaneous fat area (SCA), and visceral to subcutaneous fat ratio (VF/SC) between responders and non-responders as measured on CT abdomenTimepoint: 6 days;Need for medical rescue therapy after 5 days of treatment initiationTimepoint: 6 to 90 days;Number of patients with improvement in UCEIS by â?¥ 2 points at follow up between 30 and 90 daysTimepoint: 90 days;Number of serious infections (defined as development of fluid non-responsive shock) or herpes zoster infection at 90 daysTimepoint: 90 days;Proportion of clinical responders who achieve clinical remission (Lichtiger score â?¤2) at 90 daysTimepoint: 90 days;Proportion of patients on Tofacitinib who remain on the drug at days 30 and 90Timepoint: 30 and 90 days;Proportion of patients requiring colectomy within 30 days and 90 daysTimepoint: 30 and 90 days | — |
Countries
India
Contacts
Public ContactUmang Arora
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed