Psoriasis Clinical Trial
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
Summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Eligibility Criteria
Inclusion Criteria:
Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
Have a diagnosis of PsA for at least 6 months before the first administration 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 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
Have >= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read
Have at least one of the following 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
Exclusion Criteria:
Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients
Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease
Has previously received any biologic treatment
Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor
Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
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There are 247 Locations for this study
Birmingham Alabama, 35205, United States
Flagstaff Arizona, 86001, United States
Glendale Arizona, 85306, United States
Tucson Arizona, 85704, United States
La Palma California, 90623, United States
San Diego California, 92128, United States
Whittier California, 90606, United States
Orlando Florida, 32819, United States
Palm Harbor Florida, 34684, United States
Tampa Florida, 33624, United States
Hagerstown Maryland, 21740, United States
Lansing Michigan, 48910, United States
Saint Louis Missouri, 63141, United States
Kalispell Montana, 59901, United States
Brooklyn New York, 11201, United States
Salisbury North Carolina, 28144, United States
Springboro Ohio, 45066, United States
Duncansville Pennsylvania, 16635, United States
Memphis Tennessee, 38119, United States
Austin Texas, 78731, United States
Corpus Christi Texas, 78404, United States
Mesquite Texas, 75150, United States
Waco Texas, 76710, United States
Adelaide , 5011, Australia
Hobart , 7000, Australia
Melbourne , 3124, Australia
Melbourne , 3128, Australia
Sunshine Coast , 4558, Australia
Banja Luka , 78000, Bosnia and Herzegovina
Gradiska , 78400, Bosnia and Herzegovina
Mostar , , Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Plovdiv , 4001, Bulgaria
Plovdiv , 4002, Bulgaria
Plovdiv , 4003, Bulgaria
Plovdiv , 4004, Bulgaria
Plovdiv , 4023, Bulgaria
Ruse , 7003, Bulgaria
Sevlievo , 5400, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1463, Bulgaria
Sofia , 1505, Bulgaria
Sofia , 1510, Bulgaria
Sofia , 1612, Bulgaria
Sofia , , Bulgaria
St. John's Newfoundland and Labrador, A1C 5, Canada
Toronto Ontario, M5T2S, Canada
Trois Rivieres Quebec, G8Z1Y, Canada
Quebec , G1V 3, Canada
Baoding , 71030, China
Baotou , 01401, China
Beijing , 10003, China
Beijing , 10009, China
Beijing , 10070, China
Bengbu , 23309, China
Changchun , 13002, China
Changzhou , 21300, China
Chengdu , 61004, China
Chongqing , 40001, China
Guangzhou , 51018, China
Guangzhou , 51063, China
Guiyang , 55100, China
Hangzhou , 31001, China
Linyi , 27600, China
Nanchang , 33000, China
Nanchang , 33006, China
Nanjing , 21000, China
Pingxiang , 33700, China
Shanghai , 20004, China
Shanghai , 20044, China
Shenyang , 11005, China
Taiyuan , 30605, China
Zhengzhou , 45005, China
Osijek , 31000, Croatia
Rijeka , 51000, Croatia
Split , 21000, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Brno Zidenice , 615 0, Czechia
Brno , 61141, Czechia
Brno , 656 9, Czechia
Hlucin , 748 0, Czechia
Ostrava , 702 0, Czechia
Ostrava , 70800, Czechia
Pardubice , 53002, Czechia
Prague , 150 0, Czechia
Praha 4 , 14000, Czechia
Praha , 12850, Czechia
Praha , 130 0, Czechia
Praha , 14800, Czechia
Uherske Hradiste , 68601, Czechia
Zlin , 76001, Czechia
Tallinn , 10117, Estonia
Tallinn , 13419, Estonia
Tartu , 51013, Estonia
Batumi , 6010, Georgia
Kutaisi , 4600, Georgia
Tbilisi , 01 02, Georgia
Tbilisi , 0156, Georgia
Tbilisi , 0159, Georgia
Tbilisi , 0159, Georgia
Tbilisi , 0160, Georgia
Tbilisi , 0186, Georgia
Tbilisi , 0186, Georgia
Tbilisi , 112, Georgia
Tbilisi , 159, Georgia
Tbilisi , 180, Georgia
Berlin , 12161, Germany
Hamburg , 20095, Germany
Hamburg , 22415, Germany
Herne , 44649, Germany
Magdeburg , 39110, Germany
Mainz , 55128, Germany
Ratingen , 40878, Germany
Athens , 11521, Greece
Athens , 11527, Greece
Athens , 11527, Greece
Larissa , 41110, Greece
Xanthi , , Greece
Budapest , 1027, Hungary
Budapest , 1062, Hungary
Budapest , 1152, Hungary
Budapest , H-103, Hungary
Debrecen , 4032, Hungary
Gyula , 5700, Hungary
Kistarcsa , 2143, Hungary
Szeged , 6725, Hungary
Szentes , 6600, Hungary
Szolnok , 5000, Hungary
Zalaegerszeg , H-890, Hungary
Ashkelon , 78278, Israel
Haifa , 31048, Israel
Haifa , 31096, Israel
Kfar Saba , 44281, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Catania , 95124, Italy
Milano , 20132, Italy
Napoli , 80128, Italy
Palermo , 90127, Italy
Roma , 00185, Italy
Rome , 00168, Italy
Torino , 10126, Italy
Verona , 37134, Italy
Cheonan-si , 31151, Korea, Republic of
Gwangju-si , 501-7, Korea, Republic of
Seoul , 04763, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 07061, Korea, Republic of
Seoul , 3080, Korea, Republic of
Suwon , 16499, Korea, Republic of
Adazi , LV-21, Latvia
Riga , LV 10, Latvia
Riga , LV100, Latvia
Riga , LV100, Latvia
Riga , LV100, Latvia
Kaunas , 49476, Lithuania
Kaunas , LT-50, Lithuania
Klaipeda , LT-92, Lithuania
Siauliai , LT-76, Lithuania
Vilnius , LT-08, Lithuania
Batu Caves , 68100, Malaysia
Ipoh , 30990, Malaysia
Kuala Lumpur , 59100, Malaysia
Melaka , 75400, Malaysia
Petaling Jaya, Selangor , 47500, Malaysia
Seremban , 70300, Malaysia
Angeles , 2009, Philippines
Cebu , 6000, Philippines
Dasmarinas , 4114, Philippines
Davao City , , Philippines
Davao , 8000, Philippines
Las Pinas , 1740, Philippines
Manila , 1000, Philippines
Manila , 1000, Philippines
Manila , 1000, Philippines
Bialystok , 15-35, Poland
Bialystok , 15-87, Poland
Bydgoszcz , 85-06, Poland
Bydgoszcz , 85-16, Poland
Elblag , 82-30, Poland
Elblag , 82-30, Poland
Gdynia , 81 33, Poland
Kraków , 30-51, Poland
Lublin , 20-60, Poland
Nadarzyn , 05-83, Poland
Nowa Sol , 67-10, Poland
Poznan , 61-39, Poland
Torun , 87-10, Poland
Warsaw , 00-87, Poland
Warszawa , 02-11, Poland
Warszawa , 02-65, Poland
Wroclaw , 51 50, Poland
Chelyabinsk , 45409, Russian Federation
Izhevsk , 42600, Russian Federation
Kazan , 42009, Russian Federation
Kemerovo , 64402, Russian Federation
Moscow , 10904, Russian Federation
Moscow , 11904, Russian Federation
Moscow , 12911, Russian Federation
Moscow , 19006, Russian Federation
Novosibirsk , 63009, Russian Federation
Orenburg , 46000, Russian Federation
Petrozavodsk , 18501, Russian Federation
Ryazan , 39000, Russian Federation
Ryazan , 39002, Russian Federation
Ryazan , 39002, Russian Federation
Sankt-Petersburg. , 19525, Russian Federation
Saratov , 41005, Russian Federation
St. Petersburg , 19525, Russian Federation
St.-Petersburg , 19101, Russian Federation
Ulyanovsk , 43206, Russian Federation
Vladimir , 60002, Russian Federation
Yaroslavl , 15000, Russian Federation
Yaroslavl , 15000, Russian Federation
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Kragujevac , 34000, Serbia
Niska Banja , 18205, Serbia
Novi Sad , 21000, Serbia
Kosice , 4011, Slovakia
Martin , 036 0, Slovakia
Puchov , 020 0, Slovakia
Rimavska Sobota , , Slovakia
Izo , 6310, Slovenia
Ljubljana , , Slovenia
Maribor , 2000, Slovenia
A Coruna , 15006, Spain
Cordoba , 14004, Spain
Madrid , 28041, Spain
Malaga , 29009, Spain
Murcia , 30120, Spain
Móstoles , 28935, Spain
Santiago de Compostela , 15076, Spain
Santiago de Compostela , 15705, Spain
Santiago de Compostela , 15706, Spain
Sevilla , 41009, Spain
Sevilla , 41010, Spain
Hsin Chu , 30059, Taiwan
Kaohsiung , 81362, Taiwan
Kaohsiung , 83301, Taiwan
Taichung , 40447, Taiwan
Taipei , 10002, Taiwan
Tao-Yuan , 333, Taiwan
Yung-Kang, Tainan , 710, Taiwan
Istanbul , 07070, Turkey
Izmir , 35430, Turkey
Kocaeli , 41000, Turkey
Konya , 42081, Turkey
Cherkasy , 18009, Ukraine
Kharkiv , 61039, Ukraine
Kharkiv , 61204, Ukraine
Khmelnitsky , 29000, Ukraine
Kiev , 04070, Ukraine
Kryvyi Rih , 50056, Ukraine
Kyiv , 03037, Ukraine
Kyiv , 03049, Ukraine
Kyiv , 03151, Ukraine
Kyiv , 1601, Ukraine
Kyiv , 4107, Ukraine
Kyiv , 4210, Ukraine
Kyiv , , Ukraine
Odessa , 65025, Ukraine
Odessa , 65026, Ukraine
Poltava , 36011, Ukraine
Sumy , 40031, Ukraine
Ternopil , , Ukraine
Vinnytsia , 21029, Ukraine
Vinnytsya , 21009, Ukraine
Zhytomyr , 10002, Ukraine
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