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

Bristol-Myers Squibb175 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

175

Conditions

Colitis, Ulcerative

Interventions

OzanimodDRUG

Specified Dose on Specified Days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Local Institution - 0001

Berlin, Germany

Outcomes

Primary Outcomes

Number of participants with Clinical Remission, defined by a partial Mayo Score (pMayo) of ≤1 plus an RBS=0

Time frame: At week 10

Secondary Outcomes

Persistence of therapy during the study course measured by the number of participants who are on continuous treatment

Time frame: Up to Week 52

Number of participants with Clinical Response

Time frame: At Week 10 and Week 52

Number of participants with Clinical Remission

Time frame: Up to Week 52

Number of participants with clinical remission at week 52 in patients who showed clinical response at week 10

Time frame: Up to Week 52

Treatment modalities measured by the Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9)

Time frame: Up to 1 Year

Patient's satisfaction with therapy measured by the TSQM-9

Time frame: Up to 1 Year

Time to discontinuation of treatment

Time frame: Up to 1 Year

Change from baseline in Patient-Reported Outcomes (PROs) with regards to fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

Time frame: Up to 1 Year

Change from baseline in PROs with regards to quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.