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Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients

Ulcerative Colitis Clinical Trial

Official title:
Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients

Clinical Trial Summary

As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following approval (until 19 September 2022). Out of all the enrolled patients, at least 18 cases (20%) will be followed up until the 52nd week to see the long term safety of Xeljanz.

Clinical Trial Description

This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians (ie, investigators). The study population will be adult patients with moderately to severely active UC who have had an inadequate response or intolerance to the basic treatments or biological agents. Clinical Severity of Ulcerative Colitis is classified as mild, moderate, or severe based on the Mayo score or partial Mayo score. Xeljanz will be administered according to the "Dosage and Administration" of the approved labeling. There is no visit or activity mandated by this study. The investigator will collect patient data and record the information on each patient's case report form (CRF). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04071405
Study type Observational
Source Pfizer
Contact
Status Completed
Phase
Start date May 12, 2020
Completion date September 26, 2022
View Details
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