Evaluating Ozanimod for Ulcerative Colitis Treatment
Ulcerative Colitis in Subjects of Clinical Routine: A Four Year, Multicenter, Prospective, Non-Interventional Study to Evaluate Utilization, Effectiveness, and Quality of Life With Ozanimod
This study is testing how well Ozanimod works for people with moderate-to-severe ulcerative colitis who are just starting this treatment and how it affects their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05382715 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor the utilization, effectiveness, and quality of life of patients with moderate-to-severe ulcerative colitis who are treated with Ozanimod (Zeposia®). Participants will be those who are naïve to Ozanimod and are recommended for this therapy by their physician. The study will assess treatment persistence and overall patient outcomes while adhering to the approved treatment guidelines. Data will be collected to understand the real-world impact of Ozanimod on patients' lives.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of moderate-to-severe ulcerative colitis who have never been treated with Ozanimod.
Not a fit: Patients with mild ulcerative colitis or those who have previously received Ozanimod will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Ozanimod in improving the quality of life for patients with ulcerative colitis.
How similar studies have performed: Other studies have shown positive outcomes with similar treatments for ulcerative colitis, indicating a potential for success with this approach.
Eligibility criteria
Show full 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.
Where this trial is running
Berlin
- Local Institution - 0001 — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center http://www.bmsstudyconnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.