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Xeljanz Special Investigation for Long-term Use in UC Patients

Sponsor
Pfizer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03643211
Collaborator
(none)
1
Enrollment
1
Location
50.3
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    XELJANZ(REGISTERED) TABLETS 5 MG SPECIAL INVESTIGATION(INVESTIGATION OF LONG-TERM USE IN PATIENTS WITH ULCERATIVE COLITIS)
    Actual Study Start Date :
    Jun 8, 2018
    Anticipated Primary Completion Date :
    Aug 16, 2022
    Anticipated Study Completion Date :
    Aug 16, 2022

    Outcome Measures

    Primary Outcome Measures

    1. The incident condition of major adverse drug reactions (adverse events for which the causal relationship with Xeljanz cannot be ruled out) [60 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with ulcerative colitis treated with XELJANZ

    • Patients naive to XELJANZ in the treatment of ulcerative colitis

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Local Country Office Tokyo Japan

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT03643211
    Other Study ID Numbers:
    • A3921248
    First Posted:
    Aug 22, 2018
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pfizer
    Xeljanz
    Ulcerative colitis
    UC
    Long-term
    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer

    Study Results

    No Results Posted as of Jan 28, 2022