A Phase 3, Randomized, Double blind, Placebo controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response or are Intolerant to Biologic DMARD Therapy
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy
-Male or female participants who are 18-75 years of age (20-75 years of age at sites in Japan), on the day of signing initial informed consent
-Meet Classification Criteria for Psoriatic Arthritis (CASPAR)
-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 (lack of efficacy after 12 weeks or more duration of therapy) or intolerance to at least one and not more than 3 bioDMARDs administered for the treatment of PsA or psoriasis, as per local guidelines / standard of care
-Prior to the first dose of study drug on Day 1, treatment with bioDMARD(s) should have been discontinued
-Prior exposure to a JAK inhibitor > 2 doses
-Any active / recent infection
-Any chronic and / or uncontrolled medical condition that would put the subject at increased risk during study participation or circumstances which may make a subject 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 of 16 years old
-Active autoimmune disease other than those listed above, that would interfere with assessment of study parameters or increase risk to the subject 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
18age old over
75age old under
Both
Active Psoriatic Arthritis
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 Administration for Investigational material : Filgotinib 200 mg or Filgotinib 100 mg
one tablet administered orally once daily
control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -
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
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 safety and tolerability of filgotinib
