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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05817942
Other study ID # GLPG0634-CL-425
Secondary ID 105477
Status Recruiting
Phase
First received
Last updated
Start date June 12, 2023
Est. completion date December 2025

Study information

Verified date June 2024
Source Galapagos NV
Contact Galapagos Medical Information
Phone +3215342900
Email medicalinfo@glpg.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Filgotinib
Jyseleca

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Sponsors (1)

Lead Sponsor Collaborator
Galapagos NV

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Ireland,  Italy,  Netherlands,  Norway,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment Persistence Rate at week 52. The persistence rate is defined as the percentage of participants who have continued filgotinib treatment since initiation. Week 52
Secondary Treatment Persistence Rate at weeks 10 and 24 Weeks 10, 24
Secondary Clinical Response Rate Weeks 10, 24, 52
Secondary Clinical Remission Rate Weeks 10, 24, 52
Secondary 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
Secondary Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS) Baseline, Weeks 10, 24, 52
Secondary Change from Baseline in HRQoL as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) Baseline, Weeks 10, 24, 52
Secondary Number of Participants with Adverse Events (AEs) Up to 52 Weeks
Secondary Number of Participants with Serious Adverse Events (SAEs) Up To 52 Weeks
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