FILOSOPHY
Research type
Research Study
Full title
A prospective, non-interventional study of the effectiveness, safety, and health related outcomes in patients with moderate to severe active rheumatoid arthritis receiving filgotinib
IRAS ID
299066
Contact name
James Galloway
Contact email
Sponsor organisation
Galapagos NV
Clinicaltrials.gov Identifier
EU/1/20/1480, Product Reference
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Rheumatoid Arthritis (RA) is a chronic autoimmune disease which causes pain, swelling and stiffness in the joints. The condition usually affects the hands, feet and wrists. In RA, the body’s immune system attacks the cells that line the joints by mistake, making the joints swollen, stiff and painful. Many patients with RA eventually become unable to work due to chronic disability. Despite advances in treatment of rheumatoid arthritis (RA), there remains substantial unmet need for patients.
Filgotinib is a medication that can help reduce inflammation, and was approved for use in the EU on 24th September 2020 for the treatment of moderate to severe active RA.
The purpose of this voluntary observational study is to collect data to understand the effectiveness and safety of filgotinib when used as a treatment for moderate to severe active RA. This will provide a greater understanding of filgotinib as it is used in real-life healthcare settings.
No tests or procedures will be performed in this study, only data relating to the treatment the participants receive for their RA will be collected. Participants will be involved in the study for approximately 2 years. During this time they will be asked to complete 4 simple questionnaires at different stages of the study. Approximately 1500 participants across 100 sites in Europe will be enrolled into this study.
This study is sponsored by Galapagos NV.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
21/NW/0176
Date of REC Opinion
11 Jun 2021
REC opinion
Further Information Favourable Opinion