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NCT03643211 Clinical Trial

Xeljanz Special Investigation for Long-term Use in UC Patients

Ulcerative Colitis Clinical Trial

Official title:
XELJANZ(REGISTERED) TABLETS 5 MG SPECIAL INVESTIGATION(INVESTIGATION OF LONG-TERM USE IN PATIENTS WITH ULCERATIVE COLITIS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03643211
Other study ID # A3921248
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 8, 2018
Est. completion date November 10, 2022

Study information
Verified date February 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice

Description:

This investigation aims to examine the safety and effectiveness of Xeljanz in post-marketing clinical settings when it is administered chronically to patients with ulcerative colitis, based on the approval conditions.

Recruitment information / eligibility
Status Completed
Enrollment 2043
Est. completion date November 10, 2022
Est. primary completion date November 10, 2022
Accepts healthy volunteers No
Gender All
Age group 0 Years and older
Eligibility Inclusion Criteria: - Patients with ulcerative colitis treated with XELJANZ - Patients naive to XELJANZ in the treatment of ulcerative colitis Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Pfizer Local Country Office Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incident condition of major adverse drug reactions (adverse events for which the causal relationship with Xeljanz cannot be ruled out) Primary outcome measure is the incident condition of major adverse drug reactions (adverse events for which the causal relationship with Xeljanz cannot be ruled out) in 60 weeks observation period. 60 weeks
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