A Post-Marketing Surveillance Study to Assess Safety of O... | NCT06073873

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

NCT06073873

Sponsor

Bristol-Myers Squibb

Status

Recruiting

Last Update Posted

Aug 22, 2024Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Ulcerative Colitis

Interventions

Ozanimod

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2024Actual

Primary Completion Date

Apr 1, 2028Estimated

Completion Date

Apr 1, 2028Estimated

First Submitted Date

Oct 3, 2023

First Submission Date that Met QC Criteria

Oct 3, 2023

First Posted Date

Oct 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2024

Last Update Posted Date

Aug 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants with moderate to severe active ulcerative colitis treated with ozanimod			Drug: Ozanimod

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ozanimod	Drug	According to local product label	Participants with moderate to severe active ulcerative colitis treated with ozanimod

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events	The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs for ozanimod	Up to 52 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population will consist of participants with moderately to severely active ulcerative colitis who will receive at least 1 dose of ozanimod according to local product label. Moderate to severe disease will be defined as a Mayo score of 6 to 12 and an endoscopic sub-score of 2 or higher. Participants will be eligible if they had an inadequate response, lost response, or were intolerant to conventional therapy (5-aminosalicylic acid, corticosteroids, immunosuppressants) or biologic agents.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bristol-Myers Squibb YH	Recruiting	Seoul		06178	South Korea

Label	URL
BMS Clinical Trial Information	View source
FDA Safety Alerts and Recalls	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided