A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea

The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bristol-Myers Squibb YH

Seoul, 06178, South Korea

Location status: Recruiting

Location contact

Hyunho Kim

CONTACT

[email protected]

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult participants 19 years of age or older
Participants who will receive ozanimod according to the approved label after enrollment
Participants who sign the informed consent form voluntarily

Exclusion criteria

Participants who are prescribed ozanimod for therapeutic indications not approved in Korea
Participants for whom ozanimod is contraindicated as clarified in Korean prescribing information approved by Ministry of Food and Drug Safety

Treatment and study plan

Ozanimod

Drug

According to local product label

Primary outcomes

Adverse events

Time frame: Up to 52 weeks

The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs for ozanimod

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Post-Marketing Surveillance (PMS) Study on Zeposia® (Ozanimod) Use Among Moderate to Severe Active Ulcerative Colitis Patients in Korea

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Oct 10, 2023
Registry last updated: Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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