Phase 3 study in participants with RA
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy
IRAS ID
212896
Contact name
David Walker
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-000570-37
Clinicaltrials.gov Identifier
2016-000570-37, EudraCT number: ; 115,510, IND number
Duration of Study in the UK
3 years, 0 months, 29 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. One of the current primary treatments for RA is methotrexate. However, some patients have an inadequate response to methotrexate so further treatments are still being sought for more effective RA control. 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.
In this study, approximately 1200 male and female RA patients will be enrolled at about 250 sites across the world.
Participants will be randomised into 4 different treatment groups; participants will have 1 out of 6 chances to receive filgotinib (100 mg) and Methotrexate (MTX), 1 out of 3 chances to receive filgotinib (200 mg) and MTX, 1 out of 6 chances to receive filgotinib (200mg) alone, and 1 out of 3 chances to receive MTX alone.
The active filgotinib and MTX, as well as the matching placebo for filgotinib and MTX will be supplied by Gilead Sciences, Inc.Eligible participants will visit their study site approximately 13 times during the 56 week treatment period to undergo various study procedures to see if filgotinib can be useful to treat RA as single therapy or in combination Methotrexate (MTX).
After the participants complete the 52 weeks of study visits, they may be offered the option to enter a Long-Term Extension study.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0403
Date of REC Opinion
14 Nov 2016
REC opinion
Further Information Favourable Opinion