A prospective placebo-controlled randomized clinical study of tofacitinib as an adjunct to corticosteroids in acute severe ulcerative colitis

Dayanand Medical College & Hospital0 sites104 target enrollmentJune 14, 2023

Overview

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38131615/ (added 27/12/2023)

Registry

who.int

Start Date

June 14, 2023

End Date

March 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.