Filgotinib with csDMARDs in RA patients
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment
IRAS ID
208315
Contact name
David Walker
Contact email
Sponsor organisation
Gilead Sciences, Inc
Eudract number
2016-000569-21
Clinicaltrials.gov Identifier
115,510, IND number
Duration of Study in the UK
1 years, 8 months, 1 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. Disease-Modifying Antirheumatic Drugs (DMARDs) are the current main class of treatment for RA. However, some patients have an inadequate or only partial response to DMARDs so further treatments are still being sought for more effective RA control. Filgotinib is under development as a new type of oral 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 423 male and female RA patients with inadequate response to biological DMARDs will be enrolled at multiple sites across the world. Participants will undergo background therapy with conventional synthetic DMARDs (e.g. Methotrexate) throughout the study but will also be randomly assigned to one of following groups:
-Filgotinib 100mg (+ placebo to match (PTM) filgotinib 200mg)
-Filgotinib 200mg (+ PTM filgotinib 100mg)
-Placebo (PTM filgotinib 200mg + PTM filgotinib 100mg).Eligible participants will visit their study site approximately 9 times during the 24 week treatment period to undergo various study procedures to assess the safety and effectiveness of filgotinib. At week 14, participants who have not achieved a 20% improvement from Day 1 in both swollen joint count (SJC) and tender joint count (TJC) will discontinue from study medications but continue with study procedures and assessments. After 24 weeks, depending on treatment response, participants may enrol in a Long Term Extension study.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0402
Date of REC Opinion
23 Dec 2016
REC opinion
Further Information Favourable Opinion