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 (GALOCEAN)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105477
• EU PAS number:
  EUPAS50214
• Study ID:
  105477
• Official title and acronym:
  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 (GALOCEAN)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Ireland

  Italy

  Netherlands

  Norway

  Spain

  United Kingdom
• Study description:
  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
• Study status:
  Ongoing

Research institutions and networks

Institutions

Alfasigma

Italy

Study timelines

Date when funding contract was signed

Actual: 31/05/2022

Study start date

Actual: 12/06/2023

Date of final study report

Planned: 31/12/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Alfasigma S.p.A

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable