AzTrials
AzTrials

Arthritis, PsoriaticPhase 3APEXNCT04882098

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

A Phase 3 study testing Guselkumab in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 280 sites in 29 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,054 participants
Where
280 sitesin 29 countries
Study dates
17 Jun 2021to 6 Oct 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

280 sites in 29 countries.

280 sites in 29 countries

China24 sites

  • Affiliated Hospital of Hebei University

    Baoding, 71030

  • The First Affiliated Hospital of Baotou Medical University

    Baotou, 014010

  • Peking University First Hospital

    Beijing, 100034

  • Peking University Third Hospital

    Beijing, 100191

  • Peking Union Medical College Hospital

    Beijing, 100730

  • The Affiliated Hospital of Bengbu Medical College

    Bengbu, 233099

  • The First Bethune Hospital of Jilin University

    Changchun, 130021

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213004

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180

  • the 3rd Affiliated Hospital,Sun Yansen University

    Guangzhou, 510630

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 551000

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • Linyi City People Hospital

    Linyi, 276000

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330008

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Pingxiang People's Hospital

    Pingxiang, 337000

  • Huashan Hospital Fudan University

    Shanghai, 200040

  • Shanghai skin disease hospital

    Shanghai, 200443

  • Shengjing Hospital Of China Medical University

    Shenyang, 110055

  • The hospital of Shanxi Universtidy

    Taiyuan, 30605

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

Other trials in China

United States23 sites

  • Austin Regional Clinic

    Austin, Texas, 78731

  • Rheumatology Associates

    Birmingham, Alabama, 35205

  • NYU Langone Ambulatory Care Brooklyn Heights

    Brooklyn, New York, 11201

  • Adriana Pop Moody MD Clinic PA

    Corpus Christi, Texas, 78404

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Arizona Arthritis and Rheumatology Research PLLC

    Flagstaff, Arizona, 86001-6218

  • Arizona Arthritis & Rheumatology Associates PC

    Glendale, Arizona, 85306

  • Klein And Associates M D P A

    Hagerstown, Maryland, 21740

  • Glacier View Research Institute

    Kalispell, Montana, 59901-3158

  • Advanced Medical Research

    La Palma, California, 90624

  • Dr. Ramesh Gupta

    Memphis, Tennessee, 38119

  • Southwest Rheumatology Research LLC

    Mesquite, Texas, 75150

  • Advanced Rheumatology

    Okemos, Michigan, 48864

  • Heuer M.D. Research

    Orlando, Florida, 32819

  • The Arthritis Center, Inc.

    Palm Harbor, Florida, 34684

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Rheumatology Center of San Diego

    San Diego, California, 92128

  • STAT Research, Inc.

    Springboro, Ohio, 45342

  • Arthritis Consultants

    St Louis, Missouri, 63141

  • Forcare Clinical Research Inc

    Tampa, Florida, 33624

  • Arizona Arthritis & Rheumatology Research, PLLC

    Tucson, Arizona, 85704

  • Arthritis And Osteoporosis Clinic

    Waco, Texas, 76710

  • Medvin Clinical Research, Inc.

    Whittier, California, 90606

Other trials in United States

Russia22 sites

  • Chelyabinsk Regional Clinical Dermatovenerological Dispensary

    Chelyabinsk, 454092

  • LLC Aliance Biomedical-Ural group

    Izhevsk, 426061

  • State Budgetary Educational Institution of High Professional Education

    Kazan', 420097

  • Medical Center LLC Maxsimum Zdoroviya

    Kemerovo, 644024

  • LLC Family Outpatient Clinic # 4

    Moscow, 109044

  • GUZ of Moscow City Clinical Hospital # 1 n.a.N.I.Pirogov

    Moscow, 119049

  • GU Moscow Regional Research Clinical Institute n.a. M.F.Vla

    Moscow, 129110

  • FGBU Research Institute of Rheumatology named V.A.Nasonova

    Moscow, 190068

  • LLC Consultative and Diagnostic Center of Rheumatology Heal

    Novosibirsk, 630099

  • GBUZ Orenburg Clinical Regional Hospital

    Orenburg, 460000

  • Republican Hospital n.a.V.A.Baranov

    Petrozavodsk, 185019

  • Ryazan Regional Clinical Dermatovenerological Dispensary

    Ryazan, 390000

  • Ryazan Regional Clinical Cardiology Center

    Ryazan, 390026

  • Ryazan Regional Clinical Hospital

    Ryazan, 390026

  • Federal North-West Medical Research Centre

    Saint Petersburg, 194214

  • LLC Sanavita

    Saint Petersburg, 195257

  • Northen-Western State Medical University n.a. I.I. Mechnikov

    Saint Petersburg, 196066

  • Sararov Regional Clinical Hospital

    Saratov, 410053

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, 432063

  • State Budget Healthcare Institution of Vladimir Region Regional Clinical Hospital

    Vladimir, 600023

  • Clinical Hospital #3

    Yaroslavl, 150007

  • Clinical Emergency Hospital n.a. N.V. Solovyev

    Yaroslavl, 150054

Other trials in Russia

Ukraine21 sites

  • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009

  • Derzhavna ustanova Natsionalnyi instytut terapii imeni L.T.Maloi NAMN Ukrainy viddil klinichnoi

    Kharkiv, 61039

  • Municipal Institution Regional hospital-center of emergency care and disasters medicine

    Kharkiv, 61058

  • Khmelnitska oblasna likarnia

    Khmelnitsky

  • TOV Revmocentr

    Kiev, 02081

  • Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi rady

    Kryvyi Rih

  • Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud

    Kyiv, 03037

  • Kyiv Railway Station Clinical Hospital #2

    Kyiv, 03049

  • State Institution Railway clinical Hospital 2

    Kyiv, 03049

  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

    Kyiv, 03151

  • Olexandrivska Clinical Hospital of Kyiv City

    Kyiv, 04050

  • Kyivska oblasna klinichna likarnia

    Kyiv, 04106

  • Center of Family Medicine Plus LLC

    Kyiv, 04210

  • Multidisciplinary Medical Center of Odessa National Medical University

    Odesa, 65006

  • Odeska oblasna klinichna likarnia

    Odesa, 65025

  • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil

    Poltava

  • Sumska oblasna klinichna likarnia

    Sumy

  • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

    Ternopil

  • Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

    Vinnytsia, 21009

  • Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]

    Vinnytsia, 21029

  • Zhytomyr Central City Hospital #1

    Zhytomyr, 10002

Other trials in Ukraine

Poland17 sites

  • Osteo-Medic s.c A. Racewicz, J Supronik

    Bialystok, 15-351

  • ClinicMed Badurski i Wspolnicy Spolka Jawna

    Bialystok, 15-879

  • Nasz Lekarz Przychodnie Medyczne

    Bydgoszcz, 85-068

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

    Elblag, 82 300

  • Ambulatorium Barbara Bazela

    Elblag, 82-300

  • Medica Pro Familia sp z o o S K A

    Gdynia, 81-338

  • Pratia MCM Krakow

    Krakow, 30 510

  • REUMED Zespol Poradni Specjalistycznych Filia nr 2

    Lublin, 20-607

  • NZOZ Lecznica Mak-Med sc

    Nadarzyn, 05-830

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100

  • Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj

    Poznan, 61 397

  • Nasz Lekarz Przychodnie Medyczne 1

    Torun, 87-100

  • Medycyna Kliniczna

    Warsaw, 00-874

  • Rheuma Medicus Zaklad Opieki Zdrowotnej

    Warsaw, 02 118

  • Reumatika-Centrum Reumatologii, NZOZ

    Warsaw, 02-655

  • DERMMEDICA Sp.z o.o.

    Wroclaw, 51 503

Other trials in Poland

Bulgaria15 sites

  • Medical Center Medconsult-Pleven

    Pleven, 5800

  • Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

    Plovdiv, 4000

  • UMHAT Kaspela 1

    Plovdiv, 4001

  • UMHAT Kaspela

    Plovdiv, 4001

  • MHAT Trimantium

    Plovdiv, 4002

  • Multiprofile Hospital for Active Treatment Plovdiv

    Plovdiv, 4003

  • Medical Center Unimed Plovdiv

    Plovdiv, 4023

  • Medical Center Teodora

    Rousse, 7003

  • DCC Convex EOOD

    Sofia, 1336

  • UMHAT Sv. Ivan Rilski

    Sofia, 1431

  • UMHAT Sv. Ivan Rilski 1

    Sofia, 1463

  • DCC XVII-Sofia EOOD

    Sofia, 1505

  • Medical Center Hera EOOD

    Sofia, 1510

  • UMHAT St. Ivan Rilski

    Sofia, 1606

  • St Ivan Rilski University Multiprofile Hospital For Active Treatment

    Sofia, 1680

Other trials in Bulgaria

Czechia14 sites

  • Revmaclinic

    Brno, 61141

  • Revmatologie s r o

    Brno, 656 91

  • Revmacentrum MUDr Mostera s r o

    Brno-Židenice, 615 00

  • L K N Arthrocentrum

    Hlučín, 748 01

  • CCBR Ostrava s r o

    Ostrava, 702 00

  • MUDr Rosypalova s r o

    Ostrava, 70800

  • CCBR Klinicka centra Czech, a.s.

    Pardubice, 53002

  • Revmatologicky institut

    Prague, 12850

  • CCR Prague s.r.o.

    Prague, 130 00

  • Revmatologicka ambulance

    Prague, 14000

  • Affidea Praha s r o

    Prague, 14800

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Medical Plus S R O

    Uherské Hradiště, 68601

  • PV Medical S R O

    Zlín, 76001

Other trials in Czechia

Georgia12 sites

  • LTD Unimed Adjara

    Batumi, 6010

  • LTD Clinic LJ

    Kutaisi, 4600

  • Aleksandre Aladashvili Clinic LLC 1

    Tbilisi, 01 02

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi, 0112

  • Ltd Medicore

    Tbilisi, 0112

  • Raymann Ltd

    Tbilisi, 0156

  • J S C K Eristavi National Cen

    Tbilisi, 0159

  • Tbilisi Heart and Vascular Clinic Ltd

    Tbilisi, 0159

  • LTD MediClub Georgia

    Tbilisi, 0160

  • Consilium Medulla-multiprofile clinic Ltd

    Tbilisi, 0186

  • JSC Evex Hospitals

    Tbilisi, 159

  • LTD The First Medical Center

    Tbilisi, 180

Other trials in Georgia

Spain12 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp Reina Sofia

    Córdoba, 14004

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp Regional Univ de Malaga

    Málaga, 29009

  • Hosp. Univ. de Mostoles

    Móstoles, 28935

  • Hosp. Univ. Virgen de La Arrixaca

    Murcia, 30120

  • Hosp. Univ. Infanta Sofia

    San Sebastián de los Reyes, 28702

  • Complejo Hospitalario Universitario de Santiago. Servicio de Aparato Digestivo

    Santiago de Compostela, 15076

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15702

  • Hosp. Nuestra Senora de La Esperanza

    Santiago de Compostela, 15705

  • Hosp. Virgen Macarena

    Seville, 41009

  • Hosp. Infanta Luisa

    Seville, 41013

Other trials in Spain

Hungary11 sites

  • Revita Rendelo

    Budapest, 1027

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Uno Medical Trials Ltd.

    Budapest, 1152

  • Qualiclinic Kft

    Budapest, H-1036

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Synexus Magyarorszag Kft 1

    Gyula, 5700

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

  • Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ

    Szeged, 6725

  • Csongrád Megyei Dr. Bugyi István Kórház

    Szentes, 6600

  • MAV Korhaz es Rendelointezet

    Szolnok, 5000

  • Synexus Magyarorszag Kft

    Zalaegerszeg, H-8900

Other trials in Hungary

Philippines9 sites

  • Angeles University Foundation Medical Center

    Angeles, 2009

  • Cebu Doctors' University Hospital

    Cebu, 6000

  • De La Salle University Medical Center

    Dasmariñas, 4114

  • Southern Philippines Medical Center

    Davao City, 8000

  • Davao Doctors Hospital

    Davao City

  • University of Perpetual Help Dalta Medical Center, Inc

    Las Piñas, 1740

  • Manila Doctors Hospital

    Manila, 1000

  • Medical Center Manila

    Manila, 1000

  • Philippine General Hospital

    Manila, 1000

Other trials in Philippines

Italy8 sites

  • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

    Catania, 95121

  • A.O.U. Città della Salute e della Scienza

    Foligno, 06034

  • Ospedale San Raffaele, IRCCS

    Milan, 20132

  • AOU Università degli Studi della Campania L. Vanvitelli

    Naples, 80128

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Complesso Integrato Columbus

    Rome, 00168

  • Università di Roma La Sapienza

    Torino, 10128

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37134

Other trials in Italy

Taiwan8 sites

  • National Taiwan University Hospital 1

    Hsinchu, 30059

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Chang Gung Medical Foundation

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40447

  • Chi Mei Medical Center Yong Kang

    Tainan, 710

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 112

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

Germany7 sites

  • Rheumatologische Schwerpunktpraxis

    Berlin, 12161

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095

  • Praxis fur Klinische Studien und Praxis fur Orthopadie

    Hamburg, 22415

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Institut Fur Praventive Medizin Klinische Forschung GbR

    Magdeburg, 39110

  • Gemeinschaftspraxis Dres. Quist

    Mainz, 55128

  • Rheumazentrum Ratingen

    Ratingen, 40878

Other trials in Germany

Israel7 sites

  • Barzilai Medical Center

    Ashkelon, 78278

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Health Care Campus

    Haifa, 3109601

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Serbia7 sites

  • Institute Of Rheumatology 1

    Belgrade, 11000

  • Institute Of Rheumatology 2

    Belgrade, 11000

  • Institute of Rheumatology

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • University Clinical Center Kragujevac

    Kragujevac, 34000

  • Institute for Treatment and Rehabilitation Niska Banja

    Niška Banja, 18205

  • Special Hospital for Rheumatic Diseases

    Novi Sad, 21000

Other trials in Serbia

South Korea7 sites

  • Soonchunhyang University Cheonan Hospital

    Cheonan-si, 31151

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Hanyang University Hospital

    Seoul, 04763

  • Asan Medical Center

    Seoul, 05505

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 07061

  • Seoul National University Hospital

    Seoul, 3080

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Croatia6 sites

  • Ch Osijek

    Osijek, 31000

  • KBC Rijeka

    Rijeka, 51000

  • University Hospital Center Split

    Split, 21000

  • Klinicki bolnicki centar Zagreb

    Zagreb, 10000

  • Medicinski centar Kuna & Peric

    Zagreb, 10000

  • University Hospital Sveti Duh

    Zagreb, 10000

Other trials in Croatia

Latvia6 sites

  • M & M Centrs Ltd

    Adazi, LV-2164

  • P. Stradina Clinical University Hospital

    Riga, LV 1002

  • Riga East Clinical University Hospital

    Riga, LV-1038

  • Riga 1st Hospital

    Riga, LV1001

  • J Kisis Ltd

    Riga, LV1003

  • Orto Clinic Ltd

    Riga, LV1005

Other trials in Latvia

Malaysia6 sites

  • Hospital Selayang

    Batu Caves, 68100

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30990

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Melaka

    Malacca, 75400

  • Sunway Medical Centre

    Petaling Jaya, 47500

  • Hospital Tuanku Jaafar

    Seremban, 70300

Other trials in Malaysia

Australia5 sites

  • The Queen Elizabeth Hospital

    Adelaide, 5011

  • Southern Clinical Research

    Hobart, 7000

  • Emeritus Research

    Melbourne, 3124

  • Eastern Health - Box Hill Hospital

    Melbourne, 3128

  • Rheumatology Research Unit

    Sunshine Coast, 4558

Other trials in Australia

Bosnia and Herzegovina5 sites

  • University Clinical center Republic of Srpska 1

    Banja Luka, 78000

  • University Clinical center Republic of Srpska

    Banja Luka, 78000

  • Health center Gradiska

    Gradiska, 78400

  • Clinical hospital Mostar

    Mostar

  • Clinical Center University of Sarajevo

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Greece5 sites

  • Democritus University of Thrace

    Alexandroupoli, 68 100

  • Naval Hospital of Athens

    Athens, 11521

  • Hippokration Hospital

    Athens, 11527

  • Laiko General Hospital of Athens

    Athens, 11527

  • University Hospital Of Larissa, Biopolis

    Larissa, 41110

Other trials in Greece

Lithuania5 sites

  • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

    Kaunas, LT-50161

  • Practice Dr Pociene Gilvina

    Kaunas, LT-51270

  • Klaipeda University Hospital

    Klaipėda, LT-92288

  • Siauliai Republican Hospital, Public Institution

    Šiauliai, LT-76231

  • JSC Inlita, Santaros KTC

    Vilnius, LT-08406

Other trials in Lithuania

Canada4 sites

  • Group De Recherche En Rhumatologie Et Maladies Osseuses

    Québec, Quebec, G1V 3M7

  • Eastern Regional Health Authority St Clares Mercy Hospital

    St. John's, Newfoundland and Labrador, A1C 5B8

  • Toronto Western Hospital

    Toronto, Ontario, M5T2S8

  • Centre de Recherche Musculo Squelettique

    Trois-Rivières, Quebec, G9A 3Y2

Other trials in Canada

Slovakia4 sites

  • Paediatric University Hospital

    Košice, 4011

  • Reumatologicka ambulancia

    Martin, 036 01

  • Chiremed, s.r.o.

    Púchov, 020 01

  • Reumex s.r.o

    Rimavská Sobota

Other trials in Slovakia

Turkey (Türkiye)4 sites

  • Akdeniz University Medical Faculty

    Istanbul, 07070

  • Izmir Katip Celebi University

    Izmir, 35430

  • Kocaeli University Medical Faculty

    Kocaeli, 41000

  • Selcuk University Medical Faculty

    Konya, 42081

Other trials in Turkey (Türkiye)

Estonia3 sites

  • OU Innomedica

    Tallinn, 10117

  • North Estonia Medical Centre

    Tallinn, 13419

  • Sihtasutus Tartu Ulikooli Kliinikum - Nahahaiguste Kliinik

    Tartu, 50106

Other trials in Estonia

Slovenia3 sites

  • Splosna bolnisnica Izola

    Izo, 6310

  • Bolnica Dr. Petra Drzaja

    Ljubljana

  • UKC Maribor Dermatology clinic

    Maribor, 2000

Other trials in Slovenia

About this study

Official title: 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.

Being tested
Guselkumab, Placebo
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GuselkumabDrug

    Also called CNTO 1959

    Participants will receive guselkumab as SC injection.

  • PlaceboDrug

    Participants will receive matching placebo as SC injection.

Study groups in NCT04882098
Study groupRoleWhat they receive
Group 1: Guselkumab and PlaceboExperimentalParticipants 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.
Receives: Drug: Guselkumab; Drug: Placebo
Group 2: GuselkumabExperimentalParticipants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Receives: Drug: Guselkumab
Group 3: Placebo Followed by GuselkumabExperimentalParticipants 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.
Receives: Drug: Guselkumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Week 24

Secondary outcomes (11)

  1. 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

    Measured: Baseline (after first administration of study drug) and Week 24

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Measured: From baseline (after first administration of study drug) up to 168 weeks

  3. Number of Participants With Serious Adverse Events (SAEs)

    Measured: From baseline (after first administration of study drug) up to 168 weeks

  4. Number of Participants With Reasonably Related Adverse Events (AEs)

    Measured: From baseline (after first administration of study drug) up to 168 weeks

  5. Number of Participants With TEAEs Leading to Discontinuation of Study Intervention

    Measured: From baseline (after first administration of study drug) up to 168 weeks

  6. Number of Participants With Treatment Emergent Infections

    Measured: From baseline (after first administration of study drug) up to 168 weeks

  7. Number of Participants With Injection-site Reactions Leading to Discontinuation of Study Intervention

    Measured: From baseline (after first administration of study drug) up to 168 weeks

  8. Number of Participants With Clinical Laboratory Abnormalities

    Measured: From baseline (after first administration of study drug) up to 168 weeks

  9. Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Toxicity Grade Laboratory Values

    Measured: From baseline (after first administration of study drug) up to 168 weeks

  10. Serum Guselkumab Concentration

    Measured: From baseline (after first administration of study drug) up to 168 weeks

  11. Number of Participants With Anti-guselkumab Antibodies

    Measured: From baseline (after first administration of study drug) up to 168 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start17 Jun 2021
  3. Primary completion30 Dec 2024
  4. Study completion6 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,054 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04882098
Sponsor's protocol ID
CR108957
Other IDs
CNTO1959PSA3004, 2020-004981-20, 2023-504734-21-00, 2023
Acronym
APEX
Status last verified
Nov 2026
First submitted
10 May 2021
Last updated
4 Nov 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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.

    PubMed 36627711

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Guselkumab in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 280 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 280 sites in China, United States, Russia, Ukraine, Poland and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04882098, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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