Long term extension study of Filgotinib in RA patients
Research type
Research Study
Full title
A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis
IRAS ID
220964
Contact name
David Walker
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-003630-25
Clinicaltrials.gov Identifier
115,510, IND No.
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Rheumatoid Arthritis (RA) is a chronic autoimmune disease affecting around 400,000 people in the UK. In an autoimmune disease, the immune system – which usually fights infection – attacks the cells that line the joints by mistake, making them swollen, stiff and painful. Hands, feet and wrists are the most commonly affected body parts in RA patients. There is currently no cure for RA but treatment includes taking medications that can relieve the symptoms and slow the progress of the condition.
Filgotinib is under development as a new type of RA treatment that can selectively block the action of certain inflammatory proteins in the body but with fewer side effects than other RA treatments.
This is a long-term extension study; patients may be enrolled in the study after they have completed one of the 4 parent RA studies (GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303).
Participants will be randomised into two study medication groups: Filgotinib 100mg group (participants take 100mg of filgotinib and one placebo tablet that looks like 200mg of filgotinib) or Filgotinib 200mg group (participants take 200mg of filgotinib and one placebo tablet that looks like 100mg of filgotinib).
Eligible participants will visit their study site at least 15 times during the treatment period to undergo various study procedures to see if filgotinib can be safe and useful in the long-term treatment of Rheumatoid Arthritis.
This study will last up to 3 years, or until filgotinib becomes commercially available, or until Gilead Sciences terminates clinical development of filgotinib; whichever comes first.
In this study, approximately 2640 male and female RA patients will be enrolled at about 350 sites across the world.
The active filgotinib, as well as the matching placebo for filgotinib, will be supplied by Gilead Sciences, Inc.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0138
Date of REC Opinion
14 Jul 2017
REC opinion
Further Information Favourable Opinion