effectiveness of tofacitinib in moderate to severe ulcerative colitis compared to steroid

Phase 4

Completed

Brief Summary: To study the effectiveness of tofacitinib as a first line therapy for treatment of moderate to severe ulcerative colitis and compare it with prednisolone. In recent clinical trials tofacitinib has been proven superior to placebo in moderate to severe UC for clinical remission and mucosal healing . The efficacy of Tofacitinib has not been directly compared against steroids. Alternative first line therapy to steroids for induction in patients with contraindication for steroids is also needed to be studied. So we planned this study to compare the efficacy of Tofacitinib against steroids for clinical remission and mucosal healing in patients having moderate to severe UC already on 5-ASA.

Recruitment & Eligibility

Inclusion Criteria

diagnosed cases of ulcerative colitis.

Exclusion Criteria

ulcerative proctitis, severe commorbidity, c.
difficile infection, toxic mega colon, any coagulopathy or hypercoaguable condition, thrombosis, pregnancy.

Primary Outcome Measures

Name	Time	Method
to compare the remission rate in both steroid and tofacitinib group	at 4th week, 8th week and 12th week

Secondary Outcome Measures

Name	Time	Method
to compare the safety profile and adverse events of the individual drugs	3 months

Locations (1): Department of gastroenterology, Post graduate institute of Medical Education and Research (PGIMER)
🇮🇳
Chandigarh, CHANDIGARH, India
Department of gastroenterology, Post graduate institute of Medical Education and Research (PGIMER)
🇮🇳Chandigarh, CHANDIGARH, India
Dr Shankar Roy
Principal investigator
09508522066
dr.shankar.ghy@gmail.com