Active Psoriatic Arthritis
Conditions
Interventions
investigational material(s)
Generic name etc : Filgotinib (GS-6034)
INN of investigational material : Filgotinib
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administ
Sponsors
Gilead Sciences, K.K.
Galapagos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Meet Classification Criteria for Psoriatic Arthritis (CASPAR) and have a history consistent with PsA 6 months or more at Screening -Have active PsA defined as 3 or more swollen joints (from a 66 swollen joint count [SJC]) and 3 or more tender joints (from a 68 tender joint count [TJC]) at Screening and Day 1; these may or may not be the same joints at Screening and Day 1 -Must have a documented history or active signs of at least one of the following at Screening: a)Plaque psoriasis b)Nail changes attributed to psoriasis -Have had inadequate response or intolerance to 1 or more conventional synthetic disease-modifying anti-rheumatic drug (csDMARD), apremilast and / or NSAID, administered over the course of 12 weeks or more for the treatment of PsA, as per local guidelines / standard of care
Exclusion criteria
Exclusion criteria: -Prior PsA or psoriasis treatment with a bioDMARD -Prior exposure to a JAK inhibitor > 2 doses -Any active / recent infection -Any chronic and / or uncontrolled medical condition that would put the individual at increased risk during study participation or circumstances which may make an individual unlikely or unable to complete or comply with study procedures and requirements, per investigator judgement -Any moderately to severely active musculoskeletal or skin disorder other than PsA or plaque psoriasis that would interfere with assessment of study parameters, as per judgement of investigator NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to PsA or additional diagnosis of PsA -Any history of an inflammatory arthropathy with onset before age 16 years old -Active autoimmune disease other than those listed above, that would interfere with assessment of study parameters or increase risk to the individual by participating in the study (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of investigator -Pregnancy or nursing females -Active drug or alcohol abuse, as per judgement of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy confirmatory -To evaluate the effect of filgotinib compared to placebo in active psoriatic arthritis (PsA) as assessed by the American College of Rheumatology 20% improvement (ACR20) response at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy confirmatory other -To evaluate the effect of filgotinib on core domains of PsA as assessed by Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA), ACR responses, PASI including BSA responses, SPARCC Enthesitis Index and LEI, LDI, PASDAS, DAPSA, mNAPSI, and PhGAP -To evaluate the effect of filgotinib on physical function in active PsA as assessed by HAQ DI -To evaluate the effect of filgotinib on fatigue and quality of life in active PsA as assessed by FACIT Fatigue, SF 36v2, and PsAID 12 -To evaluate the efficacy of filgotinib versus adalimumab in active PsA as assessed by ACR20 response -To evaluate the safety and tolerability of filgotinib | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed