Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy
NCT ID: NCT04115748
Last Updated: 2022-05-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
67 participants
INTERVENTIONAL
2019-12-03
2021-05-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Filgotinib 200 mg (Main Study)
Participants will receive filgotinib 200 mg + placebo to match (PTM) filgotinib 100 mg + PTM adalimumab injection for up to 16 weeks.
Filgotinib
Tablets administered orally once daily with or without food
Placebo to match filgotinib
Tablets administered orally once daily with or without food
Placebo to match adalimumab
Injection administered subcutaneously once every 2 weeks
Filgotinib 100 mg (Main Study)
Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg + PTM adalimumab for up to 16 weeks.
Filgotinib
Tablets administered orally once daily with or without food
Placebo to match filgotinib
Tablets administered orally once daily with or without food
Placebo to match adalimumab
Injection administered subcutaneously once every 2 weeks
Adalimumab (Main Study)
Participants will receive PTM filgotinib 200 mg + PTM filgotinib 100 mg + adalimumab 40 mg injection for up to 16 weeks.
Adalimumab
Injection administered subcutaneously once every 2 weeks
Placebo to match filgotinib
Tablets administered orally once daily with or without food
Placebo (Main Study)
Participants will receive PTM filgotinib 200 mg + PTM filgotinib 100 mg + PTM adalimumab injection for up to 16 weeks.
Placebo to match filgotinib
Tablets administered orally once daily with or without food
Placebo to match adalimumab
Injection administered subcutaneously once every 2 weeks
Filgotinib 200 mg (Long Term Extension [LTE])
Participants will receive filgotinib 200 mg + PTM filgotinib 100 mg for up to 34 weeks.
Filgotinib
Tablets administered orally once daily with or without food
Placebo to match filgotinib
Tablets administered orally once daily with or without food
Filgotinib 100 mg (LTE)
Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 34 weeks.
Filgotinib
Tablets administered orally once daily with or without food
Placebo to match filgotinib
Tablets administered orally once daily with or without food
Interventions
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Filgotinib
Tablets administered orally once daily with or without food
Adalimumab
Injection administered subcutaneously once every 2 weeks
Placebo to match filgotinib
Tablets administered orally once daily with or without food
Placebo to match adalimumab
Injection administered subcutaneously once every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have active PsA defined as ≥ 3 swollen joints (from a 66 swollen joint count \[SJC\]) and ≥ 3 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:
* Plaque psoriasis
* Nail changes attributed to psoriasis
* Have had inadequate response or intolerance to ≥1 conventional synthetic disease-modifying anti-rheumatic drug (csDMARD), apremilast and / or NSAID, administered over the course of ≥ 12 weeks for the treatment of PsA, as per local guidelines / standard of care
Exclusion Criteria
* Prior exposure to a janus kinase (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 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
18 Years
75 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Medvin Clinical Research
Covina, California, United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, United States
Omega Research Debary, LLC
DeBary, Florida, United States
San Marcus Research Clinic, Inc.
Miami, Florida, United States
Hmd Research Llc
Orlando, Florida, United States
Arthritis Center, Inc.
Palm Harbor, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
BayCare Medical Group, Inc.
Tampa, Florida, United States
North Georgia Rheumatology Group
Lawrenceville, Georgia, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, United States
St. Paul Rheumatology, P.A.
Eagan, Minnesota, United States
Arthritis Consultants, Inc.
St Louis, Missouri, United States
Physician Research Collaaboration, LLCs
Lincoln, Nebraska, United States
Atlantic Coast Research
Toms River, New Jersey, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States
Clinical Research Source Inc
Perrysburg, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Articularis Healthcare Inc, dba, Columbia Arthritis Center, PA
Columbia, South Carolina, United States
ACME Research, LLC
Orangeburg, South Carolina, United States
Arthritis & Osteoporosis Clinic of Brazos Valley (Drug Shipment Address)
College Station, Texas, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, United States
West Virginia Research Institute PLLC
South Charleston, West Virginia, United States
Genesis Research Services
Broadmeadow, New South Wales, Australia
Rheumatology Research Unit
Maroochydore, Queensland, Australia
Emeritus Research
Camberwell, Victoria, Australia
University Multiprofile Hospital for Active Treatment - Plovdiv AD, Department Of Rheumatology
Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment "Lyulin" EAD, Department of Rheumatology
Sofia, , Bulgaria
Diagnostic consultative center 17 Sofia EOOD
Sofia, , Bulgaria
"Medical center Synexus Sofia" EOOD
Sofia, , Bulgaria
"Medical center SYNEXUS SOFIA" EOOD, branch Stara Zagora
Stara Zagora, , Bulgaria
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Québec, , Canada
CCR Ostrava, s.r.o.
Ostrava, , Czechia
Synexus (DRS) - Synexus Magyarorszag Kft. Budapest
Budapest, , Hungary
Synexus (DRS) - Synexus Magyarorszag Kft. Gyula
Gyula, , Hungary
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, , Japan
Daido Clinic
Nagoya, , Japan
Nagoya City University Hospital
Nagoya, , Japan
Keio University Hospital
Tokyo, , Japan
Waikato Hospital
Hamilton, WKO, New Zealand
Optimal Clinical Trials
Auckland, , New Zealand
Capital & Coast District Health Board
Newtown, , New Zealand
Clinical Trials Unit, Timaru Hospital
Timaru, , New Zealand
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, Podlaskie, , Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela
Bydgoszcz, , Poland
NSZOZ Unica CR
Dabrówka, , Poland
Centrum Medyczne Pratia Gdynia
Gdynia, , Poland
Malopolskie Badania Kliniczne SP Z O O Sp. k.
Krakow, , Poland
NZOZ Lecznica MAK-MED s.c.
Nadarzyn, , Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn, , Poland
Medycyna Kliniczna Marzena Waszczak-Jeka
Warsaw, , Poland
Pheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, , Poland
Centrum Medyczne AMED Warszawa
Warsaw, , Poland
REUMATOLOG WARSZAWA Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler
Warsaw, , Poland
ARS RHEUMATICA Sp. Z.o.o., "REUMATIKA-Centrum Reumatologii", NZOZ
Warszawa, Mazowieckie, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Ulitsa Delegatskaya, 20, Building 1, Ulitsa Kasatkina, 7 Moscow, Russia, 127473/129301
Moskva, , Russia
LLC "Biomed"
Vladimir, , Russia
Center for medical advice and research - PRACTICE LTD
Yaroslavl, , Russia
CHA Bundang Medical Center, CHA University
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
SMG - SNU Boramae Medical Center
Seoul, , South Korea
Hospital Universitario 12 de Octubre, Avenida de Cordoba s/n, Rheumatology Service, Madrid, Spain, 28041
Madrid, , Spain
Corporacio Sanitaria Parc Tauli
Sabadell, , Spain
Hospital Universitario Marques de Valdecilla, Rheumatology Service, Avda. Valdecilla s/n, Santander, Cantabria, 39008
Santander, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Buddhist Dalin Tzu Chi Hospital
Dailin Township, , Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital
Keelung, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-001996-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JapicCTI-205202
Identifier Type: REGISTRY
Identifier Source: secondary_id
GS-US-431-4566
Identifier Type: -
Identifier Source: org_study_id
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