Acute severe ulcerative colitis (ASUC) Digestive System
Conditions
Interventions
• The eligible patients will be randomized in a 1:1 ratio based on a computer generated random numbers to receive either tofacitinib or a matching placebo.
• There will be two intervention arms
o Tofa
Sponsors
Dayanand Medical College & Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult (aged > 18 years) 2. Subjects hospitalized with ASUC, as defined by Truelove Witts criteria, i.e. 6 or more blood stained stools daily, with 1 or more of the 4 additional criteria: hemoglobin 30 mm/h, fever >37.8?, and tachycardia >90/min. 3. Subjects who are willing and able to comply with treatment plan, laboratory tests, daily bowel movement diary call, and other study procedures. 4. Subjects who are willing to provide a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients hospitalized with severe UC but did not fulfil the Truelove Witts criteria 2. Prior exposure to intravenous corticosteroids or tofacitinib within 4 weeks before hospitalization 3. Active enteric or extra-intestinal infection (including Clostridioides difficile, tuberculosis, etc.) 4. Crohn’s colitis 5. Toxic megacolon, intestinal perforation, or massive haemorrhage requiring emergency colectomy 6. Pregnancy/lactation 7. Current or prior history of thromboembolic disease 8. Subjects infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses 9. Subjects who have been vaccinated with live or attenuated vaccine within 6 weeks of baseline or scheduled to receive these vaccines during study period or within 6 weeks after last dose of study medication 10. Subjects with malignancies or a history of malignancies, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin. 11. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects responding to treatment by day 7. Response to therapy will be defined using Lichtiger index. The Lichtiger index is a clinical score incorporating the total number of stools, nocturnal frequency of stools, blood in stools, fecal incontinence, abdominal pain, abdominal tenderness, need for antidiarrheal agents and general well-being. A decline in Lichtiger index by >3 points the day 7, and an absolute score <10 for 2 consecutive days without the need for rescue therapy (infliximab/cyclosporine or colectomy) was considered as response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records at the end of the study: 1. The proportion of patients requiring medical (infliximab/cyclosporine) or surgical (colectomy) rescue therapy by day 7. 2. The duration of hospital stay 3. The proportion of patients requiring initiation of infliximab/cyclosporine or undergoing colectomy after discharge but within 90 days following randomization. | — |
Countries
India
Outcome results
None listed