Status:
COMPLETED
Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
Lead Sponsor:
Pfizer
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief 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 prac...
Detailed 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 populati...
Eligibility Criteria
Inclusion
- Adult ulcerative colitis patients with moderately to severely active disease who has received at least 1 dose of Xeljanz according to the local labeling
Exclusion
- Patients meeting any of the following criteria as per local labeling will not be included in the study.
- Patients with a history of hypersensitivity to any ingredients of this product.
- Patients with serious infection (sepsis, etc.) or active infection including localized infection.
- Patients with active tuberculosis.
- Patients with severe hepatic function disorder.
- Patients with an absolute neutrophil count (ANC) \<1,000 cells/mm3.
- Patients with a lymphocyte count \<500 cells/mm3.
- Patients with a hemoglobin level \<9 g/dL.
- Pregnant or possibly pregnant women.
- Because of lactose contained in this drug, it should not be administered to patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
Key Trial Info
Start Date :
May 12 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 26 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04071405
Start Date
May 12 2020
End Date
September 26 2022
Last Update
September 3 2024
Active Locations (1)
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1
Pfizer
Seoul, South Korea