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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Crohn Disease

Treatments: Drug: Ustekinumab

Study type: Observational

Funder types: Industry

Identifiers

NCT03942120

CR108610

CNTO1275CRD4029 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 685 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

685 participants in 1 patient group

Participants with Crohn's Disease

Description:

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.

Treatment:

Drug: Ustekinumab