At a glance
ClinicalIndex Comparison RecordN/ACompleted· 110 enrolled
Drug / intervention
Non-interventionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
In Brief
An observational study evaluating Non-intervention for Ulcerative Colitis. Completed, enrolled 110 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesSouth Korea
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartMay 2020
Primary CompletionSep 2022
TodayJul 2026
First PostedAug 28, 2019
Enrollment StartMay 12, 2020
Primary CompletionSep 26, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.8 years ago
Interventions
Non-interventionother
Non-intervention observational study