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Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab) | Clinical Trials | Clareo Health

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

Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA

NCT03942120•Janssen Korea, Ltd., Korea

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants who are administered with Stelara for the first time for the indication of Crohn's disease in accordance with the label
•Participants must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria

•\- Have contraindication to Stelara in accordance to the label

Locations (43)

Inje University Busan Paik Hospital

Busan, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

Kosin University Gospel Hospital

Busan, South Korea

Good Gangan Hospital

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Dong-A University Hospital

Busan, South Korea

Samsung ChangWon Hospital

Changwon, South Korea

Changwon Kyunngsang University Hospital

Changwonsi, South Korea

Soonchunhyang University Cheonan Hospital

Cheonan, South Korea

Dankook University Hospital

Cheonan-si, South Korea

Key Dates

Start Date

April 8, 2019

Primary Completion Date

January 14, 2022

Completion Date

January 14, 2022

Last Updated

April 27, 2025

Enrollment

685

ACTUAL participants

Conditions

Crohn Disease

Interventions

Ustekinumab

DRUG

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

NCT07245394

Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

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RECRUITING

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

NCT07089420

IBD (Inflammatory Bowel Disease)IBS - Irritable Bowel Syndrome+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Immunological Characteristics of Preclinical IBD

Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study