A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis

Study Purpose

The purpose of this study is to monitor the use, effectiveness and treatment persistence with Ozanimod (Zeposia®) as well as quality of life in participants undergoing treatment for moderate-to-severe ulcerative colitis (UC).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Only Ozanimod (Zeposia®) naïve participants can be included into this prospective study.
  • - Participants are suitable for therapy with Ozanimod (Zeposia®) according to the physician's recommendation (made before enrollment and independently of this Non-Interventional Study (NIS)) - Treatment with Ozanimod (Zeposia®) must be in-label and follow the approved Summary of Product Characteristics (SmPC) - Participants must have confirmed diagnosis of moderate-to-severe Ulcerative Colitis.

Exclusion Criteria:

  • - Participants that have previously been treated with Ozanimod (Zeposia®) - Participants with mild Ulcerative Colitis (UC) - Participants with a stoma.
  • - Participants participating in other clinical trials.
  • - Participants with a planned surgical intervention and hospitalization due to UC.
  • - Participants with any contraindications specified in the current version of the SmPC.
Other protocol-defined Inclusion/Exclusion Criteria apply.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05382715
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative
Study Website: View Trial Website
Arms & Interventions

Arms

: Cohort 1

Interventions

Drug: - Ozanimod

Specified Dose on Specified Days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Local Institution - 0001, Berlin, Germany

Status

Recruiting

Address

Local Institution - 0001

Berlin, , 10825

Site Contact

Site 0001

Clinical.Trials@bms.com

855-907-3286

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