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

Dayanand Medical College & Hospital0 个研究点目标入组 104 人开始时间: 2023年6月14日最近更新: 2024年1月8日

适应症

试验速览

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

•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.

发起方