Galocean
Research type
Research Study
Full title
GALOCEAN: , 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
IRAS ID
323057
Contact name
John Paul Seenan
Contact email
Sponsor organisation
Galapagos NV
Clinicaltrials.gov Identifier
Not yet available, EU PAS ; To be completed , ClinicalTrials.gov
Duration of Study in the UK
0 years, 13 months, 0 days
Research summary
This is a prospective, non-interventional, multi-country cohort study to describe the effectiveness, treatment patterns, quality of life, and safety of patients with moderately or severely active ulcerative colitis treated with filgotinib in a real-world setting. Ulcerative colitis (UC) is characterized by relapsing and remitting inflammation of the large intestine and rectum. Filgotinib, a Janus kinase (JAK) inhibitor, was approved by the European Medicines Agency in November 2021 for the treatment of adult patients with moderately to severely active UC who had an inadequate response with lost response to or were intolerant to either conventional therapy or a biologic medication. Although the clinical efficacy of filgotinib was demonstrated in the interventional study setting, an understanding of its clinical impact in the real-world is needed given the heterogeneity of patients with UC in clinical practice.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
22/NW/0405
Date of REC Opinion
8 Feb 2023
REC opinion
Further Information Favourable Opinion