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NCT Number: NCT05817942

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH - Universitätsklinikum Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Filgotinib

Drug

Jyseleca

Primary outcomes

  1. 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

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

    Time frame: Weeks 10, 24, 76 and 104

  2. Clinical Response Rate

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

  3. Clinical Remission Rate

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

  4. 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

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

    Time frame: Baseline, Weeks 10, 24, 52

  6. 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

  7. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 104 Weeks

  8. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Up To 104 Weeks

Sponsors and collaborators

Lead sponsor

Alfasigma S.p.A.

Industry

Registry information

Official study title

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

Acronym: GALOCEAN

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2023
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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