Xeljanz Special Investigation for Long-term Use in UC Patients

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT03643211
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-06-08
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-22
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-10
• Results First Submitted: 2023-10-17
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Results First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2016

Inclusion Criteria

• Patients with ulcerative colitis treated with XELJANZ
• Patients naive to XELJANZ in the treatment of ulcerative colitis

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions	60 weeks	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician.

Trial Locations

Locations (1)

Pfizer Local Country Office; 🇯🇵 Tokyo, Japan