Filgotinib with Methotrexate in RA patients
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 in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
IRAS ID
208313
Contact name
David Walker
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-000568-41
Clinicaltrials.gov Identifier
115,510, IND number
Duration of Study in the UK
2 years, 7 months, 27 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 1650 male and female RA patients with inadequate response to methotrexate will be enrolled at multiple sites across the world. Participants will continue on their usual methotrexate dose throughout the study but also randomly assigned to one of following treatment groups:
-Filgotinib 100mg (+ placebo to match (PTM) filgotinib 200mg + PTM adalimumab injections)
-Filgotinib 200mg (+ PTM filgotinib 100mg + PTM adalimumab injections)
-Adalimumab 40mg (+ PTM filgotinib 100mg + PTM filgotinib 200mg)
-Placebo (PTM filgotinib 200mg, PTM filgotinib 100mg and PTM adalimumab injections). At Week 24 this group will be randomly reassigned to either the filgotinib 100mg or 200mg group.Eligible participants will visit their study site approximately 14 times during the 52 week treatment period to undergo various study procedures to assess the safety and effectiveness of filgotinib. Depending on their treatment response, there will be an option to then enroll in a Long Term Extension study.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0401
Date of REC Opinion
23 Dec 2016
REC opinion
Further Information Favourable Opinion