Phase
Condition
Psoriatic Arthritis
Joint Injuries
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the firstadministration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
- Have active PsA as defined by: at least 3 swollen joints and at least 3 tender jointsat screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciLitre (mg/dL) at screening from the central laboratory
- Have at least 1 of the PsA subsets: distal interphalangeal joint involvement,polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans,asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
- Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history ofplaque psoriasis
- Have active PsA despite previous non-biologic disease-modifying antirheumatic drugs (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy :Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3months or evidence of intolerance; Apremilast therapy is defined as taking apremilastat the marketed dose approved in the country where the study is being conducted for atleast 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAIDfor at least 4 weeks or evidence of intolerance
- Participants may have been previously treated with up to 2 anti-TNF (tumor necrosisfactor) alpha agents (approximately 30 percent [%] of the overall study population),and must document the reason for discontinuation
Exclusion
Exclusion Criteria:
- Has other inflammatory diseases that might confound the evaluations of benefit ofguselkumab therapy, including but not limited to rheumatoid arthritis (RA), axialspondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis),systemic lupus erythematosus, or Lyme disease
- Has ever received more than 2 anti-TNFalpha agents
- Has previously received any biologic treatment (other than anti-TNF alpha agents),including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab,ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment
- Has previously received any systemic immunosuppressants (for example, azathioprine,cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea,tacrolimus) within 4 weeks of the first administration of study agent
- Has received apremilast within 4 weeks prior to the first administration of studyagent
- Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K),decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor
Study Design
Study Description
Connect with a study center
Barwon Rheumatology Services
Geelong, 3220
AustraliaSite Not Available
Southern Clinical Research
Hobart, 7000
AustraliaSite Not Available
Liverpool Hospital
Liverpool, 2170
AustraliaSite Not Available
Rheumatology Research Unit
Maroochy Waters, 4558
AustraliaSite Not Available
Rheumatology Research Unit
Maroochydore, 4558
AustraliaSite Not Available
Eastern Health - Box Hill Hospital
Melbourne, 3128
AustraliaSite Not Available
Queen Elizabeth Hospital
Woodville, 5085
AustraliaSite Not Available
Queen Elizabeth Hospital
Woodville South, 5011
AustraliaSite Not Available
Eastern Regional Health Authority, St. Clare's Mercy Hospital
St. John's, Newfoundland and Labrador A1C 5B8
CanadaSite Not Available
The Waterside Clinic
Barrie, Ontario L4M 6L2
CanadaSite Not Available
Dermatrials Research
Hamilton, Ontario L8N 1Y2
CanadaSite Not Available
Skin Centre for Dermatology
Peterborough, Ontario K9J 5K2
CanadaSite Not Available
K. Papp Clinical Research
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Quebec, G1V 3M7
CanadaSite Not Available
Revmaclinic
Brno, 61141
CzechiaSite Not Available
MUDr. Rosypalova, s.r.o
Ostrava, 70800
CzechiaSite Not Available
Revmatologicky ustav
Praha, 12850
CzechiaSite Not Available
Revmatologicka ambulance
Praha 4, 14000
CzechiaSite Not Available
Medical Plus S.R.O.
Uherske Hradiste, 68601
CzechiaSite Not Available
PV-Medical S.R.O
Zlin, 76001
CzechiaSite Not Available
ISA GmbH
Berlin, 10789
GermanySite Not Available
Universitatsklinikum Frankfurt
Frankfurt, 60590
GermanySite Not Available
MVZ Rheuma
Hamburg, 20095
GermanySite Not Available
Rheumazentrum Ruhrgebiet
Herne, 44649
GermanySite Not Available
Krankenhaus St. Josef
Wuppertal, 42105
GermanySite Not Available
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1062
HungarySite Not Available
Orszagos Reumatologia es Fizioterapias Intezet
Budapest, 1023
HungarySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungarySite Not Available
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2143
HungarySite Not Available
Martinus Medicus Health Center
Szombathely, 9700
HungarySite Not Available
Seoul National University Bundang Hospital
Bundang, 13620
Korea, Republic ofSite Not Available
Hanyang University Hospital for rheumatic Diseases
Seoul, 04763
Korea, Republic ofSite Not Available
SMG - SNU Boramae Medical Center
Seoul, 7061
Korea, Republic ofSite Not Available
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon, 16499
Korea, Republic ofSite Not Available
Hospital Selayang
Batu Caves, 68100
MalaysiaSite Not Available
Hospital Pulau Pinang
Georgetown, 10990
MalaysiaSite Not Available
Hospital Raja Permaisuri Bainun
Ipoh, 30990
MalaysiaSite Not Available
Hospital Melaka
Melaka, 75400
MalaysiaSite Not Available
Hospital Tuanku Jaafar
Seremban, 70300
MalaysiaSite Not Available
Nzoz Osteo-Medic
Bialystok, 15-351
PolandSite Not Available
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz, 85-168
PolandSite Not Available
NSZOZ Unica CR
Dabrowka, 62-069
PolandSite Not Available
Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag, 82-300
PolandSite Not Available
Etyka Osrodek Badan Klinicznych
Olsztyn, 10-117
PolandSite Not Available
Centrum Medyczne Hetmańska
Poznań, 60-218
PolandSite Not Available
Nasz Lekarz Przychodnie Medyczne
Torun, 87-100
PolandSite Not Available
Medycyna Kliniczna
Warsaw, 00-874
PolandSite Not Available
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warszawa, 02-637
PolandSite Not Available
Centrum Medyczne WroMedica
Wroclaw, 51-685
PolandSite Not Available
Nzoz Biogenes Sp. Z O. O.
Wroclaw, 53-224
PolandSite Not Available
Biogenes Sp. z o. o.
Wrocław, 53-224
PolandSite Not Available
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk, 454092
Russian FederationSite Not Available
Medical and Sanitary Unit ''Severstal''
Cherepovets, 162600
Russian FederationSite Not Available
Research Institute of Dermatovenerology, Immunology
Ekaterinburg, 620076
Russian FederationSite Not Available
Medical Centre 'Maximum Health for Minimal Money'
Kemerovo, 650056
Russian FederationSite Not Available
Kirov State Medical Academy
Kirov, 610027
Russian FederationSite Not Available
Krasnoyarsk State Medical University
Krasnoyarsk, 660022
Russian FederationSite Not Available
Lipetsk Regional Dermatovenerological Dispensary
Lipetsk, 398005
Russian FederationSite Not Available
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov, 344007
Russian FederationSite Not Available
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan, 390046
Russian FederationSite Not Available
Saratov Regional Clinical Hospital
Saratov, 410053
Russian FederationSite Not Available
City Clinical Hospital # 26
St-Petersburg, 196247
Russian FederationSite Not Available
Republican Clinical Hospital - G.G. Kuvatov
Ufa, 450005
Russian FederationSite Not Available
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, 150003
Russian FederationSite Not Available
Clinical Hospital #10
Yaroslavl, 150023
Russian FederationSite Not Available
Hosp. Univ. A Coruña
A Coruna, 15006
SpainSite Not Available
Hosp. Gral. Univ. de Alicante
Alicante, 0-3010
SpainSite Not Available
Hosp. Univ. de Cruces
Barakaldo, 48903
SpainSite Not Available
Hosp. Del Mar
Barcelona, 08003
SpainSite Not Available
Hosp. Univ. de Basurto
Bilbao, 48013
SpainSite Not Available
Hosp. Reina Sofia
Cordoba, 14004
SpainSite Not Available
Hosp. Univ. de Getafe
Getafe, 28905
SpainSite Not Available
Hosp. Gral. Univ. Gregorio Marañon
Madrid, 28007
SpainSite Not Available
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Regional Carlos Haya
Málaga, 29009
SpainSite Not Available
Hosp. de Merida
Mérida, 06800
SpainSite Not Available
Corporacio Sanitari Parc Tauli
Sabadell, 08208
SpainSite Not Available
H.U. Infanta Sofía
San Sebastián De Los Reyes, 28702
SpainSite Not Available
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
SpainSite Not Available
Hosp. Infanta Luisa
Sevilla, 41010
SpainSite Not Available
Hosp. Unv. de Valme
Sevilla, 414014
SpainSite Not Available
Hosp. de Manises
Valencia, 46940
SpainSite Not Available
Hosp. Mexoeiro
Vigo, 36200
SpainSite Not Available
Hualien Tzu Chi Hospital
Hualien City, 970
TaiwanSite Not Available
Chang Gung Memorial Hospital Kaohsiung Branch
Kaohsiung, 833
TaiwanSite Not Available
Kaohsiung Veterans General Hospital
Kaohsiung, 81362
TaiwanSite Not Available
Chung Shan Medical University Hospital
Taichung, 402
TaiwanSite Not Available
National Cheng Kung University Medical Center
Tainan, 704
TaiwanSite Not Available
Chang Kung Memorial Hospital
Taipei, 105
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 10002
TaiwanSite Not Available
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, 333
TaiwanSite Not Available
Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, 18009
UkraineSite Not Available
Municipal health care institution Chernihiv Regional Hospital
Chernihiv,
UkraineSite Not Available
Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital
Ivano-Frankivsk,
UkraineSite Not Available
Communal Institution of Health Kharkiv City multifield hospital №18
Kharkiv, 61029
UkraineSite Not Available
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv,
UkraineSite Not Available
Khmelnitckiy regional hospital
Khmelnytsky,
UkraineSite Not Available
City Clinical Hospital No. 2
Kryvyi Rih, 50056
UkraineSite Not Available
Clinic of SI 'NSC 'The M.D.Strazhesko Institute of Cardiology' of NAMS of Ukraine'
Kyiv,
UkraineSite Not Available
Kyiv Railway Station Clinical Hospital #2
Kyiv,
UkraineSite Not Available
Danylo Halytsky Lviv National Medical University
Lviv,
UkraineSite Not Available
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
Odessa, 65025
UkraineSite Not Available
Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
Poltava,
UkraineSite Not Available
Sumy State University
Sumy,
UkraineSite Not Available
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil,
UkraineSite Not Available
Transcarpathian Regional Clinical Hospital
Uzhgorod,
UkraineSite Not Available
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
Vinnytsya, 21009
UkraineSite Not Available
Zaporizhzhya Regional Clinical Hospital
Zaporizhzhya,
UkraineSite Not Available
Rheumatology Associates
Birmingham, Alabama 35205
United StatesSite Not Available
Arizona Arthritis & Rheumatology Associates PC
Glendale, Arizona 85306
United StatesSite Not Available
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona 85210
United StatesSite Not Available
Clinical Research Center of Connecticut
Danbury, Connecticut 06810
United StatesSite Not Available
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46256-4697
United StatesSite Not Available
The Center for Rheumatology and Bone Research
Wheaton, Maryland 20902
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Arthritis Consultants
Saint Louis, Missouri 63141
United StatesSite Not Available
Arthritis and Osteoporosis Associates
Freehold, New Jersey 07728
United StatesSite Not Available
Austin Regional Clinic
Austin, Texas 78731-3146
United StatesSite Not Available
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