Clinical trial NCT05382715: A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colitis, Ulcerative
Keywords: Colitis, Ulcerative
Zeposia
Ozanimod
Inflammatory Bowel Diseases
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-05-19
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with moderate-to-severe ulcerative colitis (UC) who initiate treatment with commercially available Ozanimod (Zeposia®) according to summary of product characteristics (SmPC) will be observed in a real-world setting in Germany over a 4-year period.

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: Number of participants with Clinical Remission, defined by a partial Mayo Score (pMayo) of ≤1 plus an RBS=0
timeFrame: At week 10
Secondary outcomes:
measure: Persistence of therapy during the study course measured by the number of participants who are on continuous treatment
timeFrame: Up to Week 52
measure: Number of participants with Clinical Response
timeFrame: At Week 10 and Week 52
measure: Number of participants with Clinical Remission
timeFrame: Up to Week 52
measure: Number of participants with clinical remission at week 52 in patients who showed clinical response at week 10
timeFrame: Up to Week 52
measure: Treatment modalities measured by the Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9)
timeFrame: Up to 1 Year
measure: Patient's satisfaction with therapy measured by the TSQM-9
timeFrame: Up to 1 Year
measure: Time to discontinuation of treatment
timeFrame: Up to 1 Year
measure: Change from baseline in Patient-Reported Outcomes (PROs) with regards to fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
timeFrame: Up to 1 Year
measure: Change from baseline in PROs with regards to quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ)
timeFrame: Up to 1 Year
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 1 Year
measure: Number of participants with Corticosteroid (CS)-Free clinical response
timeFrame: Up to 1 Year
measure: Number of participants with CS-Free clinical remission
timeFrame: Up to 1 Year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: