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

Bristol-Myers Squibb3,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Ulcerative Colitis

Interventions

OzanimodDRUG

According to local product label

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Bristol-Myers Squibb YH

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Adverse events

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

Time frame: Up to 52 weeks

Central Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

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

CONTACT

Data from ClinicalTrials.gov

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