A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX)

March 26, 2024 updated by: Janssen Research & Development, LLC

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants With Active Psoriatic Arthritis

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

950

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Adelaide, Australia, 5011
        • Recruiting
        • The Queen Elizabeth Hospital
      • Hobart, Australia, 7000
        • Recruiting
        • Southern Clinical Research
      • Melbourne, Australia, 3124
        • Recruiting
        • Emeritus Research
      • Melbourne, Australia, 3128
        • Completed
        • Eastern Health - Box Hill Hospital
      • Sunshine Coast, Australia, 4558
        • Completed
        • Rheumatology Research Unit
      • Banja Luka, Bosnia and Herzegovina, 78000
        • Recruiting
        • University Clinical center Republic of Srpska
      • Gradiska, Bosnia and Herzegovina, 78400
        • Recruiting
        • Health center Gradiska
      • Mostar, Bosnia and Herzegovina
        • Recruiting
        • Clinical hospital Mostar
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Recruiting
        • Clinical Center University of Sarajevo
      • Plovdiv, Bulgaria, 4001
        • Recruiting
        • UMHAT Kaspela
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • MHAT Trimantium
      • Plovdiv, Bulgaria, 4004
        • Recruiting
        • Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
      • Plovdiv, Bulgaria, 4023
        • Recruiting
        • Medical Center Unimed Plovdiv
      • Plovdiv, Bulgaria, 4003
        • Recruiting
        • Multiprofile Hospital for Active Treatment Plovdiv
      • Ruse, Bulgaria, 7003
        • Recruiting
        • Medical Center Teodora
      • Sevlievo, Bulgaria, 5400
        • Recruiting
        • Medical Center Medconsult-Pleven
      • Sofia, Bulgaria, 1510
        • Recruiting
        • Medical Center Hera EOOD
      • Sofia, Bulgaria, 1431
        • Recruiting
        • UMHAT Sv. Ivan Rilski
      • Sofia, Bulgaria, 1463
        • Recruiting
        • UMHAT St. Ivan Rilski
      • Sofia, Bulgaria, 1505
        • Recruiting
        • DCC XVII-Sofia EOOD
      • Sofia, Bulgaria, 1612
        • Recruiting
        • St Ivan Rilski University Multiprofile Hospital For Active Treatment
      • Sofia, Bulgaria
        • Recruiting
        • DCC Convex EOOD
      • Quebec, Canada, G1V 3M7
        • Recruiting
        • Group De Recherche En Rhumatologie Et Maladies Osseuses
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • Recruiting
        • Eastern Regional Health Authority, St. Clare's Mercy Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5T2S8
        • Recruiting
        • Toronto Western Hospital
    • Quebec
      • Trois Rivieres, Quebec, Canada, G8Z1Y2
        • Recruiting
        • Centre de Recherche Musculo Squelettique
      • Baoding, China, 71030
        • Recruiting
        • Affiliated Hospital of Hebei University
      • Baotou, China, 014010
        • Recruiting
        • The First Affiliated Hospital of Baotou Medical University
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
      • Beijing, China, 100091
        • Recruiting
        • Peking University Third Hospital
      • Beijing, China, 100700
        • Recruiting
        • Peking Union Medical College Hospital
      • Bengbu, China, 233099
        • Recruiting
        • The Affiliated Hospital of Bengbu Medical College
      • Changchun, China, 130021
        • Recruiting
        • The First Bethune Hospital of Jilin University
      • Changzhou, China, 213004
        • Recruiting
        • Changzhou No 2 Peoples Hospital
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
      • Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
      • Guangzhou, China, 510180
        • Recruiting
        • Guangzhou First Municipal People's Hospital
      • Guangzhou, China, 510630
        • Recruiting
        • the 3rd Affiliated Hospital,Sun Yansen University
      • Guiyang, China, 551000
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Linyi, China, 276000
        • Recruiting
        • Linyi City People Hospital
      • Nanchang, China, 330008
        • Recruiting
        • The Second Affiliatde Hospital To Nanchang University
      • Nanchang, China, 33006
        • Recruiting
        • The First Affiliated Hospital of NanChang University
      • Nanjing, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
      • Pingxiang, China, 337000
        • Recruiting
        • Pingxiang People's Hospital
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital Fudan University
      • Shanghai, China, 200443
        • Recruiting
        • Shanghai skin disease hospital
      • Shenyang, China, 110055
        • Recruiting
        • Shengjing Hospital of China Medical University
      • Taiyuan, China, 30605
        • Recruiting
        • The hospital of Shanxi Universtidy
      • Zhengzhou, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
      • Osijek, Croatia, 31000
        • Recruiting
        • Ch Osijek
      • Rijeka, Croatia, 51000
        • Recruiting
        • KBC Rijeka
      • Split, Croatia, 21000
        • Recruiting
        • University Hospital Center Split
      • Zagreb, Croatia, 10000
        • Recruiting
        • Medicinski centar Kuna & Peric
      • Zagreb, Croatia, 10000
        • Completed
        • Klinicki bolnicki centar Zagreb
      • Zagreb, Croatia, 10000
        • Completed
        • University Hospital Sveti Duh
      • Brno, Czechia, 61141
        • Recruiting
        • Revmaclinic
      • Brno, Czechia, 656 91
        • Recruiting
        • Revmatologie s r o
      • Brno Zidenice, Czechia, 615 00
        • Recruiting
        • Revmacentrum MUDr Mostera s r o
      • Hlucin, Czechia, 748 01
        • Completed
        • L K N Arthrocentrum
      • Ostrava, Czechia, 70800
        • Recruiting
        • MUDr Rosypalova s r o
      • Ostrava, Czechia, 702 00
        • Recruiting
        • CCBR Ostrava s r o
      • Pardubice, Czechia, 53002
        • Recruiting
        • CCBR Klinicka centra Czech, a.s.
      • Prague, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole
      • Praha, Czechia, 12850
        • Recruiting
        • Revmatologicky institut
      • Praha, Czechia, 14800
        • Recruiting
        • Affidea - Praha, s.r.o.
      • Praha, Czechia, 130 00
        • Completed
        • CCR Prague s.r.o.
      • Praha 4, Czechia, 14000
        • Recruiting
        • Revmatologicka ambulance
      • Uherske Hradiste, Czechia, 68601
        • Recruiting
        • Medical Plus S R O
      • Zlin, Czechia, 76001
        • Recruiting
        • PV Medical S R O
      • Tallinn, Estonia, 10117
        • Recruiting
        • OU Innomedica
      • Tallinn, Estonia, 13419
        • Recruiting
        • North Estonia Medical Centre
      • Tartu, Estonia, 51013
        • Recruiting
        • Sihtasutus Tartu Ulikooli Kliinikum - Nahahaiguste Kliinik
      • Batumi, Georgia, 6010
        • Recruiting
        • LTD Unimed Adjara
      • Kutaisi, Georgia, 4600
        • Recruiting
        • LTD Clinic LJ
      • Tbilisi, Georgia, 0160
        • Recruiting
        • LTD MediClub Georgia
      • Tbilisi, Georgia, 01 02
        • Recruiting
        • Aleksandre Aladashvili Clinic LLC
      • Tbilisi, Georgia, 0156
        • Recruiting
        • Raymann Ltd
      • Tbilisi, Georgia, 0159
        • Recruiting
        • J S C K Eristavi National Cen
      • Tbilisi, Georgia, 0159
        • Recruiting
        • Tbilisi Heart and Vascular Clinic Ltd
      • Tbilisi, Georgia, 0186
        • Recruiting
        • Consilium Medulla-multiprofile clinic Ltd
      • Tbilisi, Georgia, 0186
        • Recruiting
        • Ltd Medicore
      • Tbilisi, Georgia, 112
        • Recruiting
        • Aleksandre Aladashvili Clinic LLC
      • Tbilisi, Georgia, 159
        • Recruiting
        • JSC Evex Hospitals
      • Tbilisi, Georgia, 180
        • Recruiting
        • LTD The First Medical Center
      • Berlin, Germany, 12161
        • Completed
        • Rheumatologische Schwerpunktpraxis
      • Hamburg, Germany, 20095
        • Recruiting
        • Hamburger Rheuma Forschungszentrum II
      • Hamburg, Germany, 22415
        • Recruiting
        • Praxis fur Klinische Studien und Praxis fur Orthopadie
      • Herne, Germany, 44649
        • Recruiting
        • Rheumazentrum Ruhrgebiet
      • Magdeburg, Germany, 39110
        • Recruiting
        • Institut Fur Praventive Medizin Klinische Forschung GbR
      • Mainz, Germany, 55128
        • Recruiting
        • Gemeinschaftspraxis Dres. Quist
      • Ratingen, Germany, 40878
        • Recruiting
        • Rheumazentrum Ratingen
      • Athens, Greece, 11527
        • Recruiting
        • Laiko General Hospital of Athens
      • Athens, Greece, 11527
        • Recruiting
        • Hippokration Hospital
      • Athens, Greece, 11521
        • Recruiting
        • Naval Hospital of Athens
      • Larissa, Greece, 41110
        • Recruiting
        • University Hospital Of Larissa, Biopolis
      • Xanthi, Greece
        • Recruiting
        • Democritus University of Thrace
      • Budapest, Hungary, 1062
        • Recruiting
        • Magyar Honvedseg Egeszsegugyi Kozpont
      • Budapest, Hungary, 1152
        • Recruiting
        • Uno Medical Trials Ltd.
      • Budapest, Hungary, H-1036
        • Recruiting
        • Qualiclinic Kft
      • Budapest, Hungary, 1027
        • Recruiting
        • Revita Rendelo
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont
      • Gyula, Hungary, 5700
        • Recruiting
        • Synexus Magyarorszag Kft
      • Kistarcsa, Hungary, 2143
        • Recruiting
        • Pest Megyei Flor Ferenc Korhaz
      • Szeged, Hungary, 6725
        • Recruiting
        • Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
      • Szentes, Hungary, 6600
        • Recruiting
        • Csongrád Megyei Dr. Bugyi István Kórház
      • Szolnok, Hungary, 5000
        • Recruiting
        • MAV Korhaz es Rendelointezet
      • Zalaegerszeg, Hungary, H-8900
        • Recruiting
        • Synexus Magyarorszag Kft
      • Ashkelon, Israel, 78278
        • Recruiting
        • Barzilai Medical Center
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
      • Haifa, Israel, 31048
        • Recruiting
        • Bnai Zion Medical Center
      • Kfar Saba, Israel, 44281
        • Completed
        • Meir Medical Center
      • Petah Tikva, Israel, 49100
        • Completed
        • Rabin Medical Center Beilinson Campus
      • Ramat Gan, Israel, 52621
        • Recruiting
        • The Chaim Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center
      • Catania, Italy, 95124
        • Recruiting
        • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
      • Milano, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele, IRCCS
      • Napoli, Italy, 80128
        • Recruiting
        • AOU Università degli Studi della Campania L. Vanvitelli
      • Palermo, Italy, 90127
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
      • Roma, Italy, 00185
        • Completed
        • Università di Roma La Sapienza
      • Rome, Italy, 00168
        • Recruiting
        • Complesso Integrato Columbus
      • Torino, Italy, 10126
        • Recruiting
        • A.O.U. Città della Salute e della Scienza
      • Verona, Italy, 37134
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
      • Cheonan-si, Korea, Republic of, 31151
        • Recruiting
        • Soonchunhyang University Cheonan Hospital
      • Gwangju-si, Korea, Republic of, 501-757
        • Recruiting
        • Chonnam National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, Korea, Republic of, 3080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 04763
        • Recruiting
        • Hanyang University Hospital
      • Seoul, Korea, Republic of, 07061
        • Recruiting
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center
      • Suwon, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital
      • Adazi, Latvia, LV-2164
        • Recruiting
        • M & M Centrs Ltd
      • Riga, Latvia, LV 1002
        • Recruiting
        • P. Stradina Clinical University Hospital
      • Riga, Latvia, LV1001
        • Recruiting
        • Riga 1st Hospital
      • Riga, Latvia, LV1003
        • Recruiting
        • J Kisis Ltd
      • Riga, Latvia, LV1005
        • Recruiting
        • Orto Clinic Ltd
      • Kaunas, Lithuania, 49476
        • Recruiting
        • Practice Dr Pociene Gilvina
      • Kaunas, Lithuania, LT-50161
        • Recruiting
        • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
      • Klaipeda, Lithuania, LT-92288
        • Recruiting
        • Klaipeda University Hospital
      • Siauliai, Lithuania, LT-76231
        • Recruiting
        • Siauliai Republican Hospital, Public Institution
      • Vilnius, Lithuania, LT-08406
        • Recruiting
        • JSC Inlita, Santaros KTC
      • Batu Caves, Malaysia, 68100
        • Recruiting
        • Hospital Selayang
      • Ipoh, Malaysia, 30990
        • Recruiting
        • Hospital Raja Permaisuri Bainun
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre
      • Melaka, Malaysia, 75400
        • Recruiting
        • Hospital Melaka
      • Petaling Jaya, Selangor, Malaysia, 47500
        • Recruiting
        • Sunway Medical Centre
      • Seremban, Malaysia, 70300
        • Recruiting
        • Hospital Tuanku Jaafar
      • Angeles, Philippines, 2009
        • Recruiting
        • Angeles University Foundation Medical Center
      • Cebu, Philippines, 6000
        • Recruiting
        • Cebu Doctors' University Hospital
      • Dasmarinas, Philippines, 4114
        • Recruiting
        • De La Salle University Medical Center
      • Davao, Philippines, 8000
        • Recruiting
        • Southern Philippines Medical Center
      • Davao City, Philippines
        • Recruiting
        • Davao Doctors Hospital
      • Las Pinas, Philippines, 1740
        • Recruiting
        • Unviersity of Perpetual Help Dalta Medical Center, Inc
      • Manila, Philippines, 1000
        • Recruiting
        • Manila Doctors Hospital
      • Manila, Philippines, 1000
        • Recruiting
        • Philippine General Hospital
      • Manila, Philippines, 1000
        • Recruiting
        • Medical Center Manila
      • Bialystok, Poland, 15-351
        • Recruiting
        • Osteo-Medic s.c A. Racewicz, J Supronik
      • Bialystok, Poland, 15-879
        • Recruiting
        • ClinicMed Badurski i Wspolnicy Spolka Jawna
      • Bydgoszcz, Poland, 85-068
        • Recruiting
        • Nasz Lekarz Przychodnie Medyczne
      • Bydgoszcz, Poland, 85-168
        • Recruiting
        • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
      • Elblag, Poland, 82-300
        • Recruiting
        • Ambulatorium Barbara Bazela
      • Elblag, Poland, 82-300
        • Recruiting
        • Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
      • Gdynia, Poland, 81 338
        • Recruiting
        • Medica Pro Familia sp z o o S K A
      • Kraków, Poland, 30-510
        • Recruiting
        • Pratia MCM Krakow
      • Lublin, Poland, 20-607
        • Recruiting
        • REUMED Zespol Poradni Specjalistycznych Filia nr 2
      • Nadarzyn, Poland, 05-830
        • Recruiting
        • NZOZ Lecznica Mak-Med sc
      • Nowa Sol, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia - Centrum Medyczne Nowa Sol
      • Poznan, Poland, 61-397
        • Recruiting
        • Prywatna Praktyka Lekarska, Prof. UM dr hab. med. Paweł Hrycaj
      • Torun, Poland, 87-100
        • Recruiting
        • Nasz Lekarz Przychodnie Medyczne
      • Warsaw, Poland, 00-874
        • Recruiting
        • Medycyna Kliniczna
      • Warszawa, Poland, 02-118
        • Recruiting
        • Rheuma-Medicus, Zaklad Opieki Zdrowotnej
      • Warszawa, Poland, 02-655
        • Recruiting
        • Reumatika-Centrum Reumatologii, NZOZ
      • Wroclaw, Poland, 51 503
        • Recruiting
        • DERMMEDICA Sp.z o.o.
      • Chelyabinsk, Russian Federation, 454092
        • Recruiting
        • Chelyabinsk Regional Clinical Dermatovenerological Dispensary
      • Izhevsk, Russian Federation, 426009
        • Terminated
        • LLC Aliance Biomedical-Ural group
      • Kazan, Russian Federation, 420097
        • Recruiting
        • State Budgetary Educational Institution of High Professional Education
      • Kemerovo, Russian Federation, 644024
        • Recruiting
        • Medical Center LLC Maxsimum Zdoroviya
      • Moscow, Russian Federation, 109044
        • Recruiting
        • LLC Family Outpatient Clinic # 4
      • Moscow, Russian Federation, 119049
        • Terminated
        • GUZ of Moscow City Clinical Hospital # 1 n.a.N.I.Pirogov
      • Moscow, Russian Federation, 129110
        • Recruiting
        • GU Moscow Regional Research Clinical Institute n.a. M.F.Vla
      • Moscow, Russian Federation, 190068
        • Terminated
        • FGBU Research Institute of Rheumatology named V.A.Nasonova
      • Novosibirsk, Russian Federation, 630099
        • Recruiting
        • LLC Consultative and Diagnostic Center of Rheumatology Heal
      • Orenburg, Russian Federation, 460000
        • Recruiting
        • GBUZ Orenburg Clinical Regional Hospital
      • Petrozavodsk, Russian Federation, 185019
        • Terminated
        • Republican Hospital n.a.V.A.Baranov
      • Ryazan, Russian Federation, 390000
        • Recruiting
        • Ryazan Regional Clinical Dermatovenerological Dispensary
      • Ryazan, Russian Federation, 390026
        • Terminated
        • Ryazan Regional Clinical Cardiology Center
      • Ryazan, Russian Federation, 390026
        • Recruiting
        • Ryazan Regional Clinical Hospital
      • Sankt-Petersburg., Russian Federation, 195257
        • Recruiting
        • LLC Sanavita
      • Saratov, Russian Federation, 410053
        • Terminated
        • Sararov Regional Clinical Hospital
      • St. Petersburg, Russian Federation, 195257
        • Recruiting
        • Federal North-West Medical Research Centre
      • St.-Petersburg, Russian Federation, 191015
        • Terminated
        • Northen-Western State Medical University n.a. I.I. Mechnikov
      • Ulyanovsk, Russian Federation, 432063
        • Recruiting
        • Ulyanovsk Regional Clinical Hospital
      • Vladimir, Russian Federation, 600023
        • Recruiting
        • State Budget Healthcare Institution of Vladimir Region Regional Clinical Hospital
      • Yaroslavl, Russian Federation, 150003
        • Recruiting
        • Clinical Emergency Hospital n.a. N.V. Solovyev
      • Yaroslavl, Russian Federation, 150007
        • Recruiting
        • Clinical Hospital #3
      • Belgrade, Serbia, 11000
        • Recruiting
        • Military Medical Academy
      • Belgrade, Serbia, 11000
        • Recruiting
        • Institute of Rheumatology
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center Kragujevac
      • Niska Banja, Serbia, 18205
        • Recruiting
        • Institute for Treatment and Rehabilitation Niska Banja
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Special Hospital for Rheumatic Diseases
      • Kosice, Slovakia, 4011
        • Recruiting
        • Paediatric University Hospital
      • Martin, Slovakia, 036 01
        • Recruiting
        • Reumatologicka ambulancia
      • Puchov, Slovakia, 020 01
        • Recruiting
        • Chiremed, s.r.o.
      • Rimavska Sobota, Slovakia
        • Recruiting
        • Reumex s.r.o
      • Izo, Slovenia, 6310
        • Completed
        • Splosna bolnisnica Izola
      • Ljubljana, Slovenia
        • Recruiting
        • Bolnica Dr. Petra Drzaja
      • Maribor, Slovenia, 2000
        • Completed
        • UKC Maribor Dermatology clinic
      • A Coruna, Spain, 15006
        • Recruiting
        • Hosp. Univ. A Coruna
      • Cordoba, Spain, 14004
        • Recruiting
        • Hosp. Reina Sofia
      • Madrid, Spain, 28041
        • Recruiting
        • Hosp. Univ. 12 de Octubre
      • Murcia, Spain, 30120
        • Recruiting
        • Hosp. Univ. Virgen de La Arrixaca
      • Málaga, Spain, 29009
        • Recruiting
        • Hosp. Regional Univ. de Malaga
      • Móstoles, Spain, 28935
        • Recruiting
        • Hosp. Univ. de Mostoles
      • San Sebastián de los Reyes, Spain, 28702
        • Recruiting
        • Hosp. Univ. Infanta Sofia
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hosp. Clinico Univ. de Santiago
      • Santiago de Compostela, Spain, 15076
        • Recruiting
        • Complejo Hospitalario Universitario de Santiago. Servicio de Aparato Digestivo
      • Santiago de Compostela, Spain, 15705
        • Recruiting
        • Hosp. Nuestra Senora de La Esperanza
      • Sevilla, Spain, 41009
        • Recruiting
        • Hosp. Virgen Macarena
      • Sevilla, Spain, 41010
        • Recruiting
        • Hosp. Infanta Luisa
      • Hsin Chu, Taiwan, 30059
        • Recruiting
        • National Taiwan University Hospital
      • Kaohsiung, Taiwan, 81362
        • Recruiting
        • Kaohsiung Veterans General Hospital
      • Kaohsiung, Taiwan, 83301
        • Recruiting
        • Chang Gung Medical Foundation
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
      • Tao-Yuan, Taiwan, 333
        • Recruiting
        • Linkou Chang Gung Memorial Hospital
      • Yung-Kang, Tainan, Taiwan, 710
        • Recruiting
        • Chi Mei Medical Center Yong Kang
      • Istanbul, Turkey, 07070
        • Recruiting
        • Akdeniz University Medical Faculty
      • Izmir, Turkey, 35430
        • Recruiting
        • Izmir Katip Celebi University
      • Kocaeli, Turkey, 41000
        • Recruiting
        • Kocaeli University Medical Faculty
      • Konya, Turkey, 42081
        • Recruiting
        • Selcuk University Medical Faculty
      • Cherkasy, Ukraine, 18009
        • Completed
        • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
      • Kharkiv, Ukraine, 61039
        • Recruiting
        • Derzhavna ustanova Natsionalnyi instytut terapii imeni L.T.Maloi NAMN Ukrainy viddil klinichnoi
      • Kharkiv, Ukraine, 61204
        • Recruiting
        • Municipal Institution Regional hospital-center of emergency care and disasters medicine
      • Khmelnitsky, Ukraine, 29000
        • Recruiting
        • Khmelnitska oblasna likarnia
      • Kiev, Ukraine, 04070
        • Completed
        • TOV Revmocentr
      • Kryvyi Rih, Ukraine, 50056
        • Recruiting
        • Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi rady
      • Kyiv, Ukraine, 03037
        • Recruiting
        • Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
      • Kyiv, Ukraine, 03049
        • Recruiting
        • State Institution Railway clinical Hospital 2
      • Kyiv, Ukraine, 1601
        • Recruiting
        • Olexandrivska Clinical Hospital of Kyiv City
      • Kyiv, Ukraine, 4107
        • Completed
        • Kyivska oblasna klinichna likarnia
      • Kyiv, Ukraine, 4210
        • Recruiting
        • Center of Family Medicine Plus LLC
      • Kyiv, Ukraine, 03151
        • Recruiting
        • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
      • Kyiv, Ukraine
        • Completed
        • Kyiv Railway Station Clinical Hospital #2
      • Odessa, Ukraine, 65025
        • Completed
        • Odeska oblasna klinichna likarnia
      • Odessa, Ukraine, 65026
        • Recruiting
        • Multidisciplinary Medical Center of Odessa National Medical University
      • Poltava, Ukraine, 36011
        • Recruiting
        • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
      • Sumy, Ukraine, 40031
        • Recruiting
        • Sumska oblasna klinichna likarnia
      • Ternopil, Ukraine
        • Recruiting
        • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
      • Vinnytsia, Ukraine, 21029
        • Recruiting
        • Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
      • Vinnytsya, Ukraine, 21009
        • Recruiting
        • Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
      • Zhytomyr, Ukraine, 10002
        • Recruiting
        • Zhytomyr Central City Hospital #1
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Rheumatology Associates
    • Arizona
      • Flagstaff, Arizona, United States, 86001-6218
        • Recruiting
        • Arizona Arthritis and Rheumatology Research PLLC
      • Glendale, Arizona, United States, 85306
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates PC
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Arizona Arthritis & Rheumatology Research, PLLC
    • California
      • La Palma, California, United States, 90623
        • Recruiting
        • Advanced Medical Research
      • San Diego, California, United States, 92128
        • Completed
        • Rheumatology Center of San Diego
      • Whittier, California, United States, 90606
        • Completed
        • Medvin Clinical Research, Inc.
    • Florida
      • Orlando, Florida, United States, 32819
        • Recruiting
        • Heuer M.D. Research
      • Palm Harbor, Florida, United States, 34684
        • Completed
        • The Arthritis Center, Inc.
      • Tampa, Florida, United States, 33624
        • Recruiting
        • Forcare Clinical Research Inc
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Klein And Associates M D P A
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Recruiting
        • Advanced Rheumatology
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Completed
        • Arthritis Consultants
    • Montana
      • Kalispell, Montana, United States, 59901-3158
        • Recruiting
        • Glacier View Research Institute
    • New York
      • Brooklyn, New York, United States, 11201
        • Recruiting
        • NYU Langone Ambulatory Care Brooklyn Heights
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Recruiting
        • PMG Research of Salisbury
    • Ohio
      • Springboro, Ohio, United States, 45066
        • Recruiting
        • STAT Research, Inc.
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center For Clinical Research
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Dr. Ramesh Gupta
    • Texas
      • Austin, Texas, United States, 78731
        • Completed
        • Austin Regional Clinic
      • Corpus Christi, Texas, United States, 78404
        • Recruiting
        • Adriana Pop Moody MD Clinic PA
      • Mesquite, Texas, United States, 75150
        • Completed
        • Southwest Rheumatology Research LLC
      • Waco, Texas, United States, 76710
        • Recruiting
        • Arthritis & Osteoporosis Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Guselkumab and Placebo
Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.
Participants will receive matching placebo as SC injection.
Participants will receive guselkumab as SC injection.
Other Names:
  • CNTO 1959
Experimental: Group 2: Guselkumab
Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Participants will receive guselkumab as SC injection.
Other Names:
  • CNTO 1959
Experimental: Group 3: Placebo Followed by Guselkumab
Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Participants will receive matching placebo as SC injection.
Participants will receive guselkumab as SC injection.
Other Names:
  • CNTO 1959

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
Time Frame: Week 24
The ACR 20 Response is defined as greater than or equal to (>=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm= very well to 100 mm= very poor]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), [0 = no arthritis to 100 = extremely active arthritis], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24
Time Frame: Baseline and Week 24
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Baseline and Week 24
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability
Time Frame: Up to 168 weeks
Number of Participants with AEs, SAEs reasonably related AEs will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. Reasonably related AEs are those AEs which are judged related to study treatment by the investigator.
Up to 168 weeks
Number of Participants with AEs leading to Discontinuation of Study Intervention
Time Frame: Up to 168 weeks
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Up to 168 weeks
Number of Participants with Infections
Time Frame: Up to 168 weeks
Number of participants with infections will be reported.
Up to 168 weeks
Number of Participants with AEs Temporally Associated With an Injection-site Reactions
Time Frame: Up to 168 weeks
Number of participants with AEs temporally associated with an injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 168 weeks
Number of Participants With Change from Baseline in Clinical Laboratory Abnormalities
Time Frame: Baseline, up to 168 weeks
Number of participants with change from baseline in clinical laboratory abnormalities including hematology and chemistry will be reported.
Baseline, up to 168 weeks
Number of Participants with Maximum Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade Laboratory Values
Time Frame: Up to 168 weeks
Number of participants with maximum CTCAE toxicity grade laboratory values will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
Up to 168 weeks
Serum Guselkumab Concentration
Time Frame: Up to 168 weeks
Serum guselkumab concentration will be measured.
Up to 168 weeks
Number of Participants with Anti-guselkumab Antibodies
Time Frame: Up to 168 weeks
Number of participants with anti-guselkumab antibodies to guselkumab will be reported.
Up to 168 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2021

Primary Completion (Estimated)

January 10, 2025

Study Completion (Estimated)

December 8, 2027

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CR108957
  • 2020-004981-20 (EudraCT Number)
  • CNTO1959PSA3004 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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