To study the effect of tofacitinib along with corticosteroids in patients with acute severe ulcerative colitis
- Conditions
- Acute severe ulcerative colitis (ASUC)Digestive System
- Registration Number
- ISRCTN42182437
- Lead Sponsor
- Dayanand Medical College & Hospital
- Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38131615/ (added 27/12/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 104
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 <105g/L, ESR >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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects responding to treatment by day 7. Response to therapy will be defined using Lichtiger index.<br>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. <br>
- Secondary Outcome Measures
Name Time Method Measured using patient records at the end of the study:<br>1. The proportion of patients requiring medical (infliximab/cyclosporine) or surgical (colectomy) rescue therapy by day 7.<br>2. The duration of hospital stay<br>3. The proportion of patients requiring initiation of infliximab/cyclosporine or undergoing colectomy after discharge but within 90 days following randomization.