Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)

Sponsor
Janssen Korea, Ltd., Korea
Study ID
NCT03942120
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ustekinumab — DRUG
    Participants treated with ustekinumab under real world clinical practice will be observed in this study. No study drug will be administered as a part of this study.

Study Details

The purpose of post-marketing surveillance (PMS) is to assess the safety and effectiveness of ustekinumab (Stelara) for Crohn's disease participants under real world clinical practice.

Key Dates

Start date
Apr 8, 2019
Status verified
Apr 2025
Primary completion
Jan 14, 2022
Completion
Jan 14, 2022

Study Design

Enrollment
685 participants (actual)

Arms

  • Arm: Participants with Crohn's Disease
    Participants that are diagnosed with Crohn's disease will be observed in this study who are being treated with ustekinumab under real world clinical practice. Only data available per clinical practice will be collected within this study.

Primary Outcome Measure

Number of Participants with Adverse Events [ Time Frame: Approximately up to 3 years ]

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