A Prospective, Non-interventional, Multi-country Cohort Study of the Effectiveness and Safety of Filgotinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis

Alfasigma S.p.A.81 sites in 6 countries509 target enrollmentJune 12, 2023

ConditionsUlcerative Colitis

InterventionsFilgotinib

DrugsFilgotinib

Overview

Phase: Not Applicable
Intervention: Filgotinib
Conditions: Ulcerative Colitis
Sponsor: Alfasigma S.p.A.
Enrollment: 509
Locations: 81
Primary Endpoint: Treatment Persistence Rate at week 52.
Status: Active, not recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 12, 2023

End Date

December 1, 2027

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Alfasigma S.p.A.

Responsible Party

Sponsor

Eligibility Criteria

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

•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.
•Participant is diagnosed with Crohn's disease.

Arms & Interventions

Arm A: Filgotinib

Participants diagnosed with moderately or severely active UC taking filgotinib according to local treatment guidelines or routine clinical practice and product information.

Intervention: Filgotinib

Outcomes

Primary Outcomes

Treatment Persistence Rate at week 52.

Time Frame: Week 52

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

Secondary Outcomes

Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS)(Baseline, Weeks 10, 24, 52)
Number of Participants with Adverse Events (AEs)(Up to 104 Weeks)
Treatment Persistence Rate at weeks 10, 24, 76 and 104(Weeks 10, 24, 76 and 104)
Clinical Response Rate(Weeks 10, 24, 52, 76 and 104)
Clinical Remission Rate(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)(Baseline, Weeks 10, 24, 52, 76 and 104)
Change from Baseline in HRQoL as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F)(Baseline, Weeks 10, 24, 52, 76 and 104)
Number of Participants with Serious Adverse Events (SAEs)(Up To 104 Weeks)