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

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: Active, not recruiting
• Conditions: Arthritis, Psoriatic
• Intervention / Treatment: Drug: Placebo; Drug: Guselkumab

• Study Type: Interventional
• Enrollment (Actual): 1054
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5011
    • The Queen Elizabeth Hospital
  • Hobart, Australia, 7000
    • Southern Clinical Research
  • Melbourne, Australia, 3128
    • Eastern Health - Box Hill Hospital
  • Melbourne, Australia, 3124
    • Emeritus Research
  • Sunshine Coast, Australia, 4558
    • Rheumatology Research Unit
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University Clinical center Republic of Srpska
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University Clinical center Republic of Srpska 1
  • Gradiska, Bosnia and Herzegovina, 78400
    • Health center Gradiska
  • Mostar, Bosnia and Herzegovina
    • Clinical Hospital Mostar
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Clinical Center University of Sarajevo
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Medical Center Medconsult-Pleven
  • Plovdiv, Bulgaria, 4003
    • Multiprofile Hospital for Active Treatment Plovdiv
  • Plovdiv, Bulgaria, 4001
    • UMHAT Kaspela
  • Plovdiv, Bulgaria, 4002
    • MHAT Trimantium
  • Plovdiv, Bulgaria, 4023
    • Medical Center Unimed Plovdiv
  • Plovdiv, Bulgaria, 4000
    • Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
  • Plovdiv, Bulgaria, 4001
    • UMHAT Kaspela 1
  • Rousse, Bulgaria, 7003
    • Medical Center Teodora
  • Sofia, Bulgaria, 1510
    • Medical Center Hera EOOD
  • Sofia, Bulgaria, 1505
    • DCC XVII-Sofia EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT Sv. Ivan Rilski
  • Sofia, Bulgaria, 1336
    • DCC Convex EOOD
  • Sofia, Bulgaria, 1606
    • UMHAT St. Ivan Rilski
  • Sofia, Bulgaria, 1680
    • St Ivan Rilski University Multiprofile Hospital For Active Treatment
  • Sofia, Bulgaria, 1463
    • UMHAT Sv. Ivan Rilski 1
• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
      • Eastern Regional Health Authority St Clares Mercy Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5T2S8
      • Toronto Western Hospital
  • Quebec
    • Québec, Quebec, Canada, G1V 3M7
      • Group De Recherche En Rhumatologie Et Maladies Osseuses
    • Trois-Rivières, Quebec, Canada, G9A 3Y2
      • Centre de Recherche Musculo Squelettique
• China
  • Baoding, China, 71030
    • Affiliated Hospital of Hebei University
  • Baotou, China, 014010
    • The First Affiliated Hospital of Baotou Medical University
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Bengbu, China, 233099
    • The Affiliated Hospital of Bengbu Medical College
  • Changchun, China, 130021
    • The First Bethune Hospital of Jilin University
  • Changzhou, China, 213004
    • Changzhou No 2 Peoples Hospital
  • Chengdu, China, 610041
    • West China Hospital of Sichuan University
  • Chongqing, China, 400016
    • The First Affiliated Hospital of Chongqing Medical University
  • Guangzhou, China, 510180
    • Guangzhou First Municipal People's Hospital
  • Guangzhou, China, 510630
    • the 3rd Affiliated Hospital,Sun Yansen University
  • Guiyang, China, 551000
    • The Affiliated Hospital of Guizhou Medical University
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • Linyi, China, 276000
    • Linyi City People Hospital
  • Nanchang, China, 330006
    • The First Affiliated Hospital of Nanchang University
  • Nanchang, China, 330008
    • The Second Affiliated Hospital of Nanchang University
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Pingxiang, China, 337000
    • Pingxiang People's Hospital
  • Shanghai, China, 200040
    • Huashan Hospital Fudan University
  • Shanghai, China, 200443
    • Shanghai Skin Disease Hospital
  • Shenyang, China, 110055
    • Shengjing Hospital of China Medical University
  • Taiyuan, China, 30605
    • The hospital of Shanxi Universtidy
  • Zhengzhou, China, 450052
    • The First Affiliated Hospital of Zhengzhou University
• Croatia
  • Osijek, Croatia, 31000
    • Ch Osijek
  • Rijeka, Croatia, 51000
    • KBC Rijeka
  • Split, Croatia, 21000
    • University Hospital Center Split
  • Zagreb, Croatia, 10000
    • University Hospital Sveti Duh
  • Zagreb, Croatia, 10000
    • Klinicki bolnicki centar Zagreb
  • Zagreb, Croatia, 10000
    • Medicinski centar Kuna & Peric
• Czechia
  • Brno, Czechia, 61141
    • Revmaclinic
  • Brno, Czechia, 656 91
    • Revmatologie s r o
  • Brno-Židenice, Czechia, 615 00
    • Revmacentrum MUDr Mostera s r o
  • Hlučín, Czechia, 748 01
    • L K N Arthrocentrum
  • Ostrava, Czechia, 70800
    • MUDr Rosypalova s r o
  • Ostrava, Czechia, 702 00
    • CCBR Ostrava s r o
  • Pardubice, Czechia, 53002
    • CCBR Klinicka centra Czech, a.s.
  • Prague, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Prague, Czechia, 12850
    • Revmatologicky institut
  • Prague, Czechia, 130 00
    • CCR Prague s.r.o.
  • Prague, Czechia, 14000
    • Revmatologicka ambulance
  • Prague, Czechia, 14800
    • Affidea Praha s r o
  • Uherské Hradiště, Czechia, 68601
    • Medical Plus S R O
  • Zlín, Czechia, 76001
    • PV Medical S R O
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre
  • Tallinn, Estonia, 10117
    • OU Innomedica
  • Tartu, Estonia, 50106
    • Sihtasutus Tartu Ulikooli Kliinikum - Nahahaiguste Kliinik
• Georgia
  • Batumi, Georgia, 6010
    • LTD Unimed Adjara
  • Kutaisi, Georgia, 4600
    • LTD Clinic LJ
  • Tbilisi, Georgia, 0159
    • Tbilisi Heart and Vascular Clinic Ltd
  • Tbilisi, Georgia, 0186
    • Consilium Medulla-multiprofile clinic Ltd
  • Tbilisi, Georgia, 0160
    • LTD MediClub Georgia
  • Tbilisi, Georgia, 0156
    • Raymann Ltd
  • Tbilisi, Georgia, 0159
    • J S C K Eristavi National Cen
  • Tbilisi, Georgia, 159
    • Jsc Evex Hospitals
  • Tbilisi, Georgia, 180
    • LTD The First Medical Center
  • Tbilisi, Georgia, 0112
    • Aleksandre Aladashvili Clinic LLC
  • Tbilisi, Georgia, 0112
    • Ltd Medicore
  • Tbilisi, Georgia, 01 02
    • Aleksandre Aladashvili Clinic LLC 1
• Germany
  • Berlin, Germany, 12161
    • Rheumatologische Schwerpunktpraxis
  • Hamburg, Germany, 20095
    • Hamburger Rheuma Forschungszentrum II
  • Hamburg, Germany, 22415
    • Praxis fur Klinische Studien und Praxis fur Orthopadie
  • Herne, Germany, 44649
    • Rheumazentrum Ruhrgebiet
  • Magdeburg, Germany, 39110
    • Institut Fur Praventive Medizin Klinische Forschung GbR
  • Mainz, Germany, 55128
    • Gemeinschaftspraxis Dres. Quist
  • Ratingen, Germany, 40878
    • Rheumazentrum Ratingen
• Greece
  • Alexandroupoli, Greece, 68 100
    • Democritus University of Thrace
  • Athens, Greece, 11521
    • Naval Hospital of Athens
  • Athens, Greece, 11527
    • Laiko General Hospital of Athens
  • Athens, Greece, 11527
    • Hippokration Hospital
  • Larissa, Greece, 41110
    • University Hospital Of Larissa, Biopolis
• Hungary
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Egeszsegugyi Kozpont
  • Budapest, Hungary, 1027
    • Revita Rendelo
  • Budapest, Hungary, 1152
    • Uno Medical Trials Ltd.
  • Budapest, Hungary, H-1036
    • Qualiclinic Kft
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Gyula, Hungary, 5700
    • Synexus Magyarorszag Kft 1
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Ferenc Korhaz
  • Szeged, Hungary, 6725
    • Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
  • Szentes, Hungary, 6600
    • Csongrád Megyei Dr. Bugyi István Kórház
  • Szolnok, Hungary, 5000
    • MAV Korhaz es Rendelointezet
  • Zalaegerszeg, Hungary, H-8900
    • Synexus Magyarorszag Kft
• Israel
  • Ashkelon, Israel, 78278
    • Barzilai Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Haifa, Israel, 31048
    • Bnai Zion Medical Center
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center Beilinson Campus
  • Ramat Gan, Israel, 52621
    • The Chaim Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Catania, Italy, 95121
    • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
  • Milan, Italy, 20132
    • Ospedale San Raffaele, IRCCS
  • Naples, Italy, 80128
    • AOU Università degli Studi della Campania L. Vanvitelli
  • Palermo, Italy, 90127
    • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Rome, Italy, 00168
    • Complesso Integrato Columbus
  • Torino, Italy, 10126
    • A.O.U. Città della Salute e della Scienza
  • Torino, Italy, 10128
    • Università di Roma La Sapienza
  • Verona, Italy, 37134
    • Azienda Ospedaliera Universitaria Integrata Verona
• Latvia
  • Adazi, Latvia, LV-2164
    • M & M Centrs Ltd
  • Riga, Latvia, LV1003
    • J Kisis Ltd
  • Riga, Latvia, LV1005
    • Orto Clinic Ltd
  • Riga, Latvia, LV-1038
    • Riga East Clinical University Hospital
  • Riga, Latvia, LV 1002
    • P. Stradina Clinical University Hospital
  • Riga, Latvia, LV1001
    • Riga 1st Hospital
• Lithuania
  • Kaunas, Lithuania, LT-50161
    • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
  • Kaunas, Lithuania, LT-51270
    • Practice Dr Pociene Gilvina
  • Klaipėda, Lithuania, LT-92288
    • Klaipeda university hospital
  • Vilnius, Lithuania, LT-08406
    • JSC Inlita, Santaros KTC
  • Šiauliai, Lithuania, LT-76231
    • Siauliai Republican Hospital, Public Institution
• Malaysia
  • Batu Caves, Malaysia, 68100
    • Hospital Selayang
  • Ipoh, Malaysia, 30990
    • Hospital Raja Permaisuri Bainun
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Malacca, Malaysia, 75400
    • Hospital Melaka
  • Petaling Jaya, Malaysia, 47500
    • Sunway Medical Centre
  • Seremban, Malaysia, 70300
    • Hospital Tuanku Jaafar
• Philippines
  • Angeles, Philippines, 2009
    • Angeles University Foundation Medical Center
  • Cebu, Philippines, 6000
    • Cebu Doctors' University Hospital
  • Dasmariñas, Philippines, 4114
    • De La Salle University Medical Center
  • Davao City, Philippines, 8000
    • Southern Philippines Medical Center
  • Davao City, Philippines
    • Davao Doctors Hospital
  • Las Piñas, Philippines, 1740
    • University of Perpetual Help Dalta Medical Center, Inc
  • Manila, Philippines, 1000
    • Philippine General Hospital
  • Manila, Philippines, 1000
    • Manila Doctors Hospital
  • Manila, Philippines, 1000
    • Medical Center Manila
• Poland
  • Bialystok, Poland, 15-879
    • ClinicMed Badurski i Wspolnicy Spolka Jawna
  • Bialystok, Poland, 15-351
    • Osteo-Medic s.c A. Racewicz, J Supronik
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
  • Bydgoszcz, Poland, 85-068
    • Nasz Lekarz Przychodnie Medyczne
  • Elblag, Poland, 82-300
    • Ambulatorium Barbara Bazela
  • Elblag, Poland, 82 300
    • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
  • Gdynia, Poland, 81-338
    • Medica Pro Familia sp z o o S K A
  • Krakow, Poland, 30 510
    • Pratia MCM Krakow
  • Lublin, Poland, 20-607
    • REUMED Zespol Poradni Specjalistycznych Filia nr 2
  • Nadarzyn, Poland, 05-830
    • NZOZ Lecznica Mak-Med sc
  • Nowa Sól, Poland, 67-100
    • Twoja Przychodnia - Centrum Medyczne Nowa Sol
  • Poznan, Poland, 61 397
    • Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj
  • Torun, Poland, 87-100
    • Nasz Lekarz Przychodnie Medyczne 1
  • Warsaw, Poland, 00-874
    • Medycyna Kliniczna
  • Warsaw, Poland, 02-655
    • Reumatika-Centrum Reumatologii, NZOZ
  • Warsaw, Poland, 02 118
    • Rheuma Medicus Zaklad Opieki Zdrowotnej
  • Wroclaw, Poland, 51 503
    • DERMMEDICA Sp.z o.o.
• Russia
  • Chelyabinsk, Russia, 454092
    • Chelyabinsk Regional Clinical Dermatovenerological Dispensary
  • Izhevsk, Russia, 426061
    • LLC Aliance Biomedical-Ural group
  • Kazan', Russia, 420097
    • State Budgetary Educational Institution of High Professional Education
  • Kemerovo, Russia, 644024
    • Medical Center LLC Maxsimum Zdoroviya
  • Moscow, Russia, 190068
    • FGBU Research Institute of Rheumatology named V.A.Nasonova
  • Moscow, Russia, 109044
    • LLC Family Outpatient Clinic # 4
  • Moscow, Russia, 119049
    • GUZ of Moscow City Clinical Hospital # 1 n.a.N.I.Pirogov
  • Moscow, Russia, 129110
    • GU Moscow Regional Research Clinical Institute n.a. M.F.Vla
  • Novosibirsk, Russia, 630099
    • LLC Consultative and Diagnostic Center of Rheumatology Heal
  • Orenburg, Russia, 460000
    • GBUZ Orenburg Clinical Regional Hospital
  • Petrozavodsk, Russia, 185019
    • Republican Hospital n.a.V.A.Baranov
  • Ryazan, Russia, 390000
    • Ryazan Regional Clinical Dermatovenerological Dispensary
  • Ryazan, Russia, 390026
    • Ryazan Regional Clinical Cardiology Center
  • Ryazan, Russia, 390026
    • Ryazan Regional Clinical Hospital
  • Saint Petersburg, Russia, 195257
    • LLC Sanavita
  • Saint Petersburg, Russia, 194214
    • Federal North-West Medical Research Centre
  • Saint Petersburg, Russia, 196066
    • Northen-Western State Medical University n.a. I.I. Mechnikov
  • Saratov, Russia, 410053
    • Sararov Regional Clinical Hospital
  • Ulyanovsk, Russia, 432063
    • Ulyanovsk Regional Clinical Hospital
  • Vladimir, Russia, 600023
    • State Budget Healthcare Institution of Vladimir Region Regional Clinical Hospital
  • Yaroslavl, Russia, 150007
    • Clinical Hospital #3
  • Yaroslavl, Russia, 150054
    • Clinical Emergency Hospital n.a. N.V. Solovyev
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology
  • Belgrade, Serbia, 11000
    • Institute Of Rheumatology 1
  • Belgrade, Serbia, 11000
    • Institute Of Rheumatology 2
  • Kragujevac, Serbia, 34000
    • University Clinical Center Kragujevac
  • Niška Banja, Serbia, 18205
    • Institute for Treatment and Rehabilitation Niska Banja
  • Novi Sad, Serbia, 21000
    • Special Hospital for Rheumatic Diseases
• Slovakia
  • Košice, Slovakia, 4011
    • Paediatric University Hospital
  • Martin, Slovakia, 036 01
    • Reumatologicka ambulancia
  • Púchov, Slovakia, 020 01
    • Chiremed, s.r.o.
  • Rimavská Sobota, Slovakia
    • Reumex s.r.o
• Slovenia
  • Izo, Slovenia, 6310
    • Splosna bolnisnica Izola
  • Ljubljana, Slovenia
    • Bolnica Dr. Petra Drzaja
  • Maribor, Slovenia, 2000
    • UKC Maribor Dermatology clinic
• South Korea
  • Cheonan-si, South Korea, 31151
    • Soonchunhyang University Cheonan Hospital
  • Gwangju, South Korea, 501-757
    • Chonnam National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 3080
    • Seoul National University Hospital
  • Seoul, South Korea, 07061
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • Seoul, South Korea, 04763
    • Hanyang University Hospital
  • Suwon, South Korea, 16499
    • Ajou University Hospital
• Spain
  • A Coruña, Spain, 15006
    • Hosp Univ A Coruna
  • Córdoba, Spain, 14004
    • Hosp Reina Sofia
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Murcia, Spain, 30120
    • Hosp. Univ. Virgen de La Arrixaca
  • Málaga, Spain, 29009
    • Hosp Regional Univ de Malaga
  • Móstoles, Spain, 28935
    • Hosp. Univ. de Mostoles
  • San Sebastián de los Reyes, Spain, 28702
    • Hosp. Univ. Infanta Sofia
  • Santiago de Compostela, Spain, 15076
    • Complejo Hospitalario Universitario de Santiago. Servicio de Aparato Digestivo
  • Santiago de Compostela, Spain, 15705
    • Hosp. Nuestra Senora de La Esperanza
  • Santiago de Compostela, Spain, 15702
    • Hosp. Clinico Univ. de Santiago
  • Seville, Spain, 41009
    • Hosp. Virgen Macarena
  • Seville, Spain, 41013
    • Hosp. Infanta Luisa
• Taiwan
  • Hsinchu, Taiwan, 30059
    • National Taiwan University Hospital 1
  • Kaohsiung City, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • Kaohsiung City, Taiwan, 83301
    • Chang Gung Medical Foundation
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 710
    • Chi Mei Medical Center Yong Kang
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital
• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 07070
    • Akdeniz University Medical Faculty
  • Izmir, Turkey (Türkiye), 35430
    • Izmir Katip Çelebi University
  • Kocaeli, Turkey (Türkiye), 41000
    • Kocaeli University Medical Faculty
  • Konya, Turkey (Türkiye), 42081
    • Selcuk University Medical Faculty
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
  • Kharkiv, Ukraine, 61039
    • Derzhavna ustanova Natsionalnyi instytut terapii imeni L.T.Maloi NAMN Ukrainy viddil klinichnoi
  • Kharkiv, Ukraine, 61058
    • Municipal Institution Regional hospital-center of emergency care and disasters medicine
  • Khmelnitsky, Ukraine
    • Khmelnitska oblasna likarnia
  • Kiev, Ukraine, 02081
    • TOV Revmocentr
  • Kryvyi Rih, Ukraine
    • Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi rady
  • Kyiv, Ukraine, 03049
    • Kyiv Railway Station Clinical Hospital #2
  • Kyiv, Ukraine, 03037
    • Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
  • Kyiv, Ukraine, 03151
    • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
  • Kyiv, Ukraine, 03049
    • State Institution Railway clinical Hospital 2
  • Kyiv, Ukraine, 04050
    • Olexandrivska Clinical Hospital of Kyiv City
  • Kyiv, Ukraine, 04106
    • Kyivska oblasna klinichna likarnia
  • Kyiv, Ukraine, 04210
    • Center of Family Medicine Plus LLC
  • Odesa, Ukraine, 65025
    • Odeska oblasna klinichna likarnia
  • Odesa, Ukraine, 65006
    • Multidisciplinary Medical Center of Odessa National Medical University
  • Poltava, Ukraine
    • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
  • Sumy, Ukraine
    • Sumska oblasna klinichna likarnia
  • Ternopil, Ukraine
    • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
  • Vinnytsia, Ukraine, 21029
    • Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
  • Vinnytsia, Ukraine, 21009
    • Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
  • Zhytomyr, Ukraine, 10002
    • Zhytomyr Central City Hospital #1
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Rheumatology Associates
  • Arizona
    • Flagstaff, Arizona, United States, 86001-6218
      • Arizona Arthritis and Rheumatology Research PLLC
    • Glendale, Arizona, United States, 85306
      • Arizona Arthritis & Rheumatology Associates PC
    • Tucson, Arizona, United States, 85704
      • Arizona Arthritis & Rheumatology Research, PLLC
  • California
    • La Palma, California, United States, 90624
      • Advanced Medical Research
    • San Diego, California, United States, 92128
      • Rheumatology Center of San Diego
    • Whittier, California, United States, 90606
      • Medvin Clinical Research, Inc.
  • Florida
    • Orlando, Florida, United States, 32819
      • Heuer M.D. Research
    • Palm Harbor, Florida, United States, 34684
      • The Arthritis Center, Inc.
    • Tampa, Florida, United States, 33624
      • Forcare Clinical Research Inc
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Klein And Associates M D P A
  • Michigan
    • Okemos, Michigan, United States, 48864
      • Advanced Rheumatology
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Arthritis Consultants
  • Montana
    • Kalispell, Montana, United States, 59901-3158
      • Glacier View Research Institute
  • New York
    • Brooklyn, New York, United States, 11201
      • NYU Langone Ambulatory Care Brooklyn Heights
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury
  • Ohio
    • Springboro, Ohio, United States, 45342
      • STAT Research, Inc.
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Dr. Ramesh Gupta
  • Texas
    • Austin, Texas, United States, 78731
      • Austin Regional Clinic
    • Corpus Christi, Texas, United States, 78404
      • Adriana Pop Moody MD Clinic PA
    • Mesquite, Texas, United States, 75150
      • Southwest Rheumatology Research LLC
    • Waco, Texas, United States, 76710
      • Arthritis And Osteoporosis Clinic

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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.	Drug: Placebo; Participants will receive matching placebo as SC injection.; Drug: Guselkumab; 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.	Drug: Guselkumab; 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.	Drug: Placebo; Participants will receive matching placebo as SC injection.; Drug: Guselkumab; 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	ACR 20 response: >=20% improvement from baseline (bl) in both swollen (66 joints), tender (68 joints) joint count, >=20% improvement from bl in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100mm, 0=no pain, 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100mm, 0=excellent, 100=poor), physician's global assessment of disease activity (VAS; 0-100mm, 0=no arthritis activity,100=extremely active arthritis), HAQ-DI (questionnaire assessing 8 functional areas; 0-3, 0=no difficulty, 3=inability to perform task in area), and CRP. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Composite-discontinue study drug not due to ND/MD, initiate/increase DMARD/oral corticosteroid, initiate prohibited PsA treatment; Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD.	At 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	Modified vdH-S score was sum of erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score was total erosion severity in 40 joints of 2 hands and 12 joints of 2 feet, maximum erosion score=320. Each hand joint was scored on 0 to 5 with 0 =no erosion, 5 =complete collapse of bone. Foot joint was scored on 0 to 10, 0 =no erosion, 10 =complete collapse of bone. JSN score was total JSN score in same 52 joints, each joint scored on 0 to 4 with 0 indicating no JSN, and 4 indicating absence of joint space, maximum JSN score=208. Maximum modified vdH-S score=528. Higher score =severe structural destruction and complete loss of joint spaces. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD	Baseline (after first administration of study drug) and Week 24
Number of Participants With Treatment Emergent Adverse Events (TEAEs)		From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Serious Adverse Events (SAEs)		From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Reasonably Related Adverse Events (AEs)		From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With TEAEs Leading to Discontinuation of Study Intervention		From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Treatment Emergent Infections		From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Injection-site Reactions Leading to Discontinuation of Study Intervention		From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Clinical Laboratory Abnormalities		From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Toxicity Grade Laboratory Values		From baseline (after first administration of study drug) up to 168 weeks
Serum Guselkumab Concentration		From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Anti-guselkumab Antibodies		From baseline (after first administration of study drug) up to 168 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Ritchlin CT, Coates LC, Mease PJ, van der Heijde D, Song J, Jiang Y, Shawi M, Kollmeier AP, Rahman P. The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a Phase 3b, multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2023 Jan 10;24(1):22. doi: 10.1186/s13063-022-06945-y.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): December 30, 2024
• Study Completion (Estimated): October 5, 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): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis, Psoriatic; Substandard Drugs; Pharmaceutical Preparations; guselkumab
• Other Study ID Numbers: CR108957; 2020-004981-20 (EudraCT Number); CNTO1959PSA3004 (Other Identifier: Janssen Research & Development, LLC); 2023-504734-21-00 (Registry Identifier: EUCT number)

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