Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)

N/AActive Not RecruitingNCT05817942

Alfasigma S.p.A.509 enrolled

Overview

To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.

Study Type

OBSERVATIONAL

Enrollment

509

Conditions

Ulcerative Colitis

Interventions

FilgotinibDRUG

Jyseleca

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Filgotinib-naïve participants with moderately or severely active UC as judged by the physician and starting filgotinib treatment according to local treatment guidelines, routine practices and product information. Exclusion Criteria: 1. Participation in any interventional or non-interventional study without prior approval from the medical leader. This does not preclude inclusion of participants enrolled to national registries. 2. Participant is diagnosed with Crohn's disease.

Locations (81)

Outcomes

Primary Outcomes

Treatment Persistence Rate at week 52.

The persistence rate is defined as the percentage of participants who have continued filgotinib treatment since initiation.

Time frame: Week 52

Secondary Outcomes

Treatment Persistence Rate at weeks 10, 24, 76 and 104

Time frame: Weeks 10, 24, 76 and 104

Clinical Response Rate

Time frame: Weeks 10, 24, 52, 76 and 104

Clinical Remission Rate

Time frame: Weeks 10, 24, 52, 76 and 104

Change from Baseline in Health-Related Quality of Life (HRQoL) as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

Time frame: Baseline, Weeks 10, 24, 52, 76 and 104

Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS)

Time frame: Baseline, Weeks 10, 24, 52

Change from Baseline in HRQoL as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F)

Time frame: Baseline, Weeks 10, 24, 52, 76 and 104

Number of Participants with Adverse Events (AEs)

Time frame: Up to 104 Weeks

Number of Participants with Serious Adverse Events (SAEs)

Time frame: Up To 104 Weeks

Data from ClinicalTrials.gov

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