Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

Evaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst Study

This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice

TO FAst is a non-interventional study in France with primary objective to describe the clinical benefit of tofacitinib 1 year after its initiation for the treatment of moderate to severe UC in routine clinical practice. The study will also make it possible to report the clinical benefit 2 years after its initiation, to search for predictors of clinical benefit, improve our understanding of the efficacy of treatment in a real-life setting (in terms of response and speed of response), describe the characteristics of patients starting a treatment by tofacitinib, its real-life patterns of use as well as patient adherence to treatment.

Inclusion Criteria:

• Patients of 18 years old or above
• Patients with confirmed diagnosis of moderate to severe ulcerative colitis
• Patients for whom gastroenterologist decides to initiate treatment with tofacitinib as per the French SmPC
• Patients informed about the study procedures and receiving an information letter signed by the investigator

Exclusion Criteria:

• Patients who have already received tofacitinib treatment before baseline
• Patients that fulfill any of the contrindications according to the latest version of the SmPC