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

NCT04071405 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2024-09-03

Study results available
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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.

Conditions

Interventions

OTHER

Non-intervention

Non-intervention observational study

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-12
Primary Completion
2022-09-26
Completion
2022-09-26

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04071405 on ClinicalTrials.gov