A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT04963725
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    No intervention or treatment will be administered as part of this study. Data available per routine clinical practice at clinic visits as well as directly from participant using a smartphone/tablet application will be collected.

Study Details

The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.

Key Dates

Start date
Jul 18, 2021
Status verified
Apr 2025
Primary completion
Dec 1, 2022
Completion
Dec 1, 2022

Study Design

Enrollment
137 participants (actual)

Arms

  • Arm: Participants Initiating Therapy with Ustekinumab
    Data will be collected for participants in Japan who have had an inadequate response, or been intolerant to, conventional or biologic therapies. The treating physician has made the decision to initiate ustekinumab induction therapy in the routine clinical practice - either as a first or subsequent biologic therapy initiating for their moderate to severe ulcerative colitis.

Primary Outcome Measure

Percentage of Participants With a Rectal Bleeding Score of 0 or 1 [ Time Frame: Up to Week 8 ]

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