Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC) (GALOCEAN)
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| ClinicalTrials.gov Identifier: NCT05817942 |
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Recruitment Status :
Recruiting
First Posted : April 18, 2023
Last Update Posted : April 10, 2024
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Sponsor:
Galapagos NV
Information provided by (Responsible Party):
Galapagos NV
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Ulcerative Colitis | Drug: Filgotinib |
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official 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 |
| Actual Study Start Date : | June 12, 2023 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Drug: Filgotinib
Jyseleca |
Primary Outcome Measures :
- 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 Outcome Measures :
- Treatment Persistence Rate at weeks 10 and 24 [ Time Frame: Weeks 10, 24 ]
- Clinical Response Rate [ Time Frame: Weeks 10, 24, 52 ]
- Clinical Remission Rate [ Time Frame: Weeks 10, 24, 52 ]
- 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 ]
- 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 ]
- Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 52 Weeks ]
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up To 52 Weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The study population will consist of participants aged 18 years or older with moderately or severely active UC as judged by the physician and starting filgotinib treatment. Participants are enrolled across around 10 countries in Europe, including the United Kingdom.
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05817942
Contacts
| Contact: Galapagos Medical Information | +3215342900 | medicalinfo@glpg.com |
Locations
Show 66 study locations
Sponsors and Collaborators
Galapagos NV
Investigators
| Study Director: | Galapagos Study Director | Galapagos NV |
| Responsible Party: | Galapagos NV |
| ClinicalTrials.gov Identifier: | NCT05817942 |
| Other Study ID Numbers: |
GLPG0634-CL-425 105477 ( Other Identifier: HMA-EMA Catalogues ) |
| First Posted: | April 18, 2023 Key Record Dates |
| Last Update Posted: | April 10, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Galapagos NV:
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filgotinib safety efficacy |
Additional relevant MeSH terms:
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Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |