A Study of Guselkumab in Participants With Active Psoriatic Arthritis

NCT04882098 | Active Not Recruiting Phase 3 Results FDA Drug

• 4 other identifiers: CR108957CNTO1959PSA30042020-004981-202023-504734-21-00
• Study Type: interventional
• Target: 1,054
• Locations: 27 countries
• Sites: 274

Brief 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.

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (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.

  At Week 24

Secondary Outcomes (11)

• Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24

  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

Study Arms (3)

Group 1: Guselkumab and Placebo

EXPERIMENTAL

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: Guselkumab; Drug: Placebo

Group 2: Guselkumab

EXPERIMENTAL

Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.

Drug: Guselkumab

Group 3: Placebo Followed by Guselkumab

EXPERIMENTAL

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: Guselkumab; Drug: Placebo

Interventions

Guselkumab DRUG

Participants will receive guselkumab as SC injection.

Also known as: CNTO 1959

Group 1: Guselkumab and Placebo; Group 2: Guselkumab; Group 3: Placebo Followed by Guselkumab

Placebo DRUG

Participants will receive matching placebo as SC injection.

Group 1: Guselkumab and Placebo; Group 3: Placebo Followed by Guselkumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (280)

Rheumatology Associates

Birmingham, Alabama, 35205, United States

Location

Arizona Arthritis and Rheumatology Research PLLC

Flagstaff, Arizona, 86001-6218, United States

Location

Arizona Arthritis & Rheumatology Associates PC

Glendale, Arizona, 85306, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Tucson, Arizona, 85704, United States

Location

Advanced Medical Research

La Palma, California, 90624, United States

Location

Rheumatology Center of San Diego

San Diego, California, 92128, United States

Location

Medvin Clinical Research, Inc.

Whittier, California, 90606, United States

Location

Heuer M.D. Research

Orlando, Florida, 32819, United States

Location

The Arthritis Center, Inc.

Palm Harbor, Florida, 34684, United States

Location

Forcare Clinical Research Inc

Tampa, Florida, 33624, United States

Location

Klein And Associates M D P A

Hagerstown, Maryland, 21740, United States

Location

Advanced Rheumatology

Okemos, Michigan, 48864, United States

Location

Arthritis Consultants

St Louis, Missouri, 63141, United States

Location

Glacier View Research Institute

Kalispell, Montana, 59901-3158, United States

Location

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, 11201, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

STAT Research, Inc.

Springboro, Ohio, 45342, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Dr. Ramesh Gupta

Memphis, Tennessee, 38119, United States

Location

Austin Regional Clinic

Austin, Texas, 78731, United States

Location

Adriana Pop Moody MD Clinic PA

Corpus Christi, Texas, 78404, United States

Location

Southwest Rheumatology Research LLC

Mesquite, Texas, 75150, United States

Location

Arthritis And Osteoporosis Clinic

Waco, Texas, 76710, United States

Location

The Queen Elizabeth Hospital

Adelaide, 5011, Australia

Location

Southern Clinical Research

Hobart, 7000, Australia

Location

Emeritus Research

Melbourne, 3124, Australia

Location

Eastern Health - Box Hill Hospital

Melbourne, 3128, Australia

Location

Rheumatology Research Unit

Sunshine Coast, 4558, Australia

Location

University Clinical center Republic of Srpska 1

Banja Luka, 78000, Bosnia and Herzegovina

Location

University Clinical center Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

Health center Gradiska

Gradiška, 78400, Bosnia and Herzegovina

Location

Clinical hospital Mostar

Mostar, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

Medical Center Medconsult-Pleven

Pleven, 5800, Bulgaria

Location

Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

Plovdiv, 4000, Bulgaria

Location

UMHAT Kaspela 1

Plovdiv, 4001, Bulgaria

Location

UMHAT Kaspela

Plovdiv, 4001, Bulgaria

Location

MHAT Trimantium

Plovdiv, 4002, Bulgaria

Location

Multiprofile Hospital for Active Treatment Plovdiv

Plovdiv, 4003, Bulgaria

Location

Medical Center Unimed Plovdiv

Plovdiv, 4023, Bulgaria

Location

Medical Center Teodora

Rousse, 7003, Bulgaria

Location

DCC Convex EOOD

Sofia, 1336, Bulgaria

Location

UMHAT Sv. Ivan Rilski

Sofia, 1431, Bulgaria

Location

UMHAT Sv. Ivan Rilski 1

Sofia, 1463, Bulgaria

Location

DCC XVII-Sofia EOOD

Sofia, 1505, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

UMHAT St. Ivan Rilski

Sofia, 1606, Bulgaria

Location

St Ivan Rilski University Multiprofile Hospital For Active Treatment

Sofia, 1680, Bulgaria

Location

Eastern Regional Health Authority St Clares Mercy Hospital

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

Location

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Group De Recherche En Rhumatologie Et Maladies Osseuses

Québec, Quebec, G1V 3M7, Canada

Location

Centre de Recherche Musculo Squelettique

Trois-Rivières, Quebec, G9A 3Y2, Canada

Location

Affiliated Hospital of Hebei University

Baoding, 71030, China

Location

The First Affiliated Hospital of Baotou Medical University

Baotou, 014010, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

The Affiliated Hospital of Bengbu Medical College

Bengbu, 233099, China

Location

The First Bethune Hospital of Jilin University

Changchun, 130021, China

Location

Changzhou No 2 Peoples Hospital

Changzhou, 213004, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

Guangzhou First Municipal People's Hospital

Guangzhou, 510180, China

Location

the 3rd Affiliated Hospital,Sun Yansen University

Guangzhou, 510630, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, 551000, China

Location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310016, China

Location

Linyi City People Hospital

Linyi, 276000, China

Location

The First Affiliated Hospital of NanChang University

Nanchang, 330006, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, 330008, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

Pingxiang People's Hospital

Pingxiang, 337000, China

Location

Huashan Hospital Fudan University

Shanghai, 200040, China

Location

Shanghai skin disease hospital

Shanghai, 200443, China

Location

Shengjing Hospital Of China Medical University

Shenyang, 110055, China

Location

The hospital of Shanxi Universtidy

Taiyuan, 30605, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

Location

Ch Osijek

Osijek, 31000, Croatia

Location

KBC Rijeka

Rijeka, 51000, Croatia

Location

University Hospital Center Split

Split, 21000, Croatia

Location

Klinicki bolnicki centar Zagreb

Zagreb, 10000, Croatia

Location

Medicinski centar Kuna & Peric

Zagreb, 10000, Croatia

Location

University Hospital Sveti Duh

Zagreb, 10000, Croatia

Location

Revmaclinic

Brno, 61141, Czechia

Location

Revmatologie s r o

Brno, 656 91, Czechia

Location

Revmacentrum MUDr Mostera s r o

Brno-Židenice, 615 00, Czechia

Location

L K N Arthrocentrum

Hlučín, 748 01, Czechia

Location

CCBR Ostrava s r o

Ostrava, 702 00, Czechia

Location

MUDr Rosypalova s r o

Ostrava, 70800, Czechia

Location

CCBR Klinicka centra Czech, a.s.

Pardubice, 53002, Czechia

Location

Revmatologicky institut

Prague, 12850, Czechia

Location

CCR Prague s.r.o.

Prague, 130 00, Czechia

Location

Revmatologicka ambulance

Prague, 14000, Czechia

Location

Affidea Praha s r o

Prague, 14800, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Medical Plus S R O

Uherské Hradiště, 68601, Czechia

Location

PV Medical S R O

Zlín, 76001, Czechia

Location

OU Innomedica

Tallinn, 10117, Estonia

Location

North Estonia Medical Centre

Tallinn, 13419, Estonia

Location

Sihtasutus Tartu Ulikooli Kliinikum - Nahahaiguste Kliinik

Tartu, 50106, Estonia

Location

LTD Unimed Adjara

Batumi, 6010, Georgia

Location

LTD Clinic LJ

Kutaisi, 4600, Georgia

Location

Aleksandre Aladashvili Clinic LLC 1

Tbilisi, 01 02, Georgia

Location

Aleksandre Aladashvili Clinic LLC

Tbilisi, 0112, Georgia

Location

Ltd Medicore

Tbilisi, 0112, Georgia

Location

Raymann Ltd

Tbilisi, 0156, Georgia

Location

J S C K Eristavi National Cen

Tbilisi, 0159, Georgia

Location

Tbilisi Heart and Vascular Clinic Ltd

Tbilisi, 0159, Georgia

Location

LTD MediClub Georgia

Tbilisi, 0160, Georgia

Location

Consilium Medulla-multiprofile clinic Ltd

Tbilisi, 0186, Georgia

Location

JSC Evex Hospitals

Tbilisi, 159, Georgia

Location

LTD The First Medical Center

Tbilisi, 180, Georgia

Location

Rheumatologische Schwerpunktpraxis

Berlin, 12161, Germany

Location

Hamburger Rheuma Forschungszentrum II

Hamburg, 20095, Germany

Location

Praxis fur Klinische Studien und Praxis fur Orthopadie

Hamburg, 22415, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

Location

Institut Fur Praventive Medizin Klinische Forschung GbR

Magdeburg, 39110, Germany

Location

Gemeinschaftspraxis Dres. Quist

Mainz, 55128, Germany

Location

Rheumazentrum Ratingen

Ratingen, 40878, Germany

Location

Democritus University of Thrace

Alexandroupoli, 68 100, Greece

Location

Naval Hospital of Athens

Athens, 11521, Greece

Location

Hippokration Hospital

Athens, 11527, Greece

Location

Laiko General Hospital of Athens

Athens, 11527, Greece

Location

University Hospital Of Larissa, Biopolis

Larissa, 41110, Greece

Location

Revita Rendelo

Budapest, 1027, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, 1062, Hungary

Location

Uno Medical Trials Ltd.

Budapest, 1152, Hungary

Location

Qualiclinic Kft

Budapest, H-1036, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Synexus Magyarorszag Kft 1

Gyula, 5700, Hungary

Location

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, 2143, Hungary

Location

Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ

Szeged, 6725, Hungary

Location

Csongrád Megyei Dr. Bugyi István Kórház

Szentes, 6600, Hungary

Location

MAV Korhaz es Rendelointezet

Szolnok, 5000, Hungary

Location

Synexus Magyarorszag Kft

Zalaegerszeg, H-8900, Hungary

Location

Barzilai Medical Center

Ashkelon, 78278, Israel

Location

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Rabin Medical Center Beilinson Campus

Petah Tikva, 49100, Israel

Location

The Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

Catania, 95121, Italy

Location

Ospedale San Raffaele, IRCCS

Milan, 20132, Italy

Location

AOU Università degli Studi della Campania L. Vanvitelli

Naples, 80128, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Complesso Integrato Columbus

Rome, 00168, Italy

Location

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

Torino, 10126, Italy

Location

Università di Roma La Sapienza

Torino, 10128, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37134, Italy

Location

M & M Centrs Ltd

Ādaži, LV-2164, Latvia

Location

P. Stradina Clinical University Hospital

Riga, LV 1002, Latvia

Location

Riga East Clinical University Hospital

Riga, LV-1038, Latvia

Location

Riga 1st Hospital

Riga, LV1001, Latvia

Location

J Kisis Ltd

Riga, LV1003, Latvia

Location

Orto Clinic Ltd

Riga, LV1005, Latvia

Location

Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

Kaunas, LT-50161, Lithuania

Location

Practice Dr Pociene Gilvina

Kaunas, LT-51270, Lithuania

Location

Klaipeda University Hospital

Klaipėda, LT-92288, Lithuania

Location

Siauliai Republican Hospital, Public Institution

Šiauliai, LT-76231, Lithuania

Location

JSC Inlita, Santaros KTC

Vilnius, LT-08406, Lithuania

Location

Hospital Selayang

Batu Caves, 68100, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, 30990, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Hospital Melaka

Malacca, 75400, Malaysia

Location

Sunway Medical Centre

Petaling Jaya, 47500, Malaysia

Location

Hospital Tuanku Jaafar

Seremban, 70300, Malaysia

Location

Angeles University Foundation Medical Center

Angeles, 2009, Philippines

Location

Cebu Doctors' University Hospital

Cebu, 6000, Philippines

Location

De La Salle University Medical Center

Dasmariñas, 4114, Philippines

Location

Southern Philippines Medical Center

Davao City, 8000, Philippines

Location

Davao Doctors Hospital

Davao City, Philippines

Location

University of Perpetual Help Dalta Medical Center, Inc

Las Piñas, 1740, Philippines

Location

Manila Doctors Hospital

Manila, 1000, Philippines

Location

Medical Center Manila

Manila, 1000, Philippines

Location

Philippine General Hospital

Manila, 1000, Philippines

Location

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

Bialystok, 15-351, Poland

Location

ClinicMed Badurski i Wspolnicy Spolka Jawna

Bialystok, 15-879, Poland

Location

Nasz Lekarz Przychodnie Medyczne

Bydgoszcz, 85-068, Poland

Location

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168, Poland

Location

Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

Elblag, 82 300, Poland

Location

Ambulatorium Barbara Bazela

Elblag, 82-300, Poland

Location

Medica Pro Familia sp z o o S K A

Gdynia, 81-338, Poland

Location

Pratia MCM Krakow

Krakow, 30 510, Poland

Location

REUMED Zespol Poradni Specjalistycznych Filia nr 2

Lublin, 20-607, Poland

Location

NZOZ Lecznica Mak-Med sc

Nadarzyn, 05-830, Poland

Location

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, 67-100, Poland

Location

Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj

Poznan, 61 397, Poland

Location

Nasz Lekarz Przychodnie Medyczne 1

Torun, 87-100, Poland

Location

Medycyna Kliniczna

Warsaw, 00-874, Poland

Location

Rheuma Medicus Zaklad Opieki Zdrowotnej

Warsaw, 02 118, Poland

Location

Reumatika-Centrum Reumatologii, NZOZ

Warsaw, 02-655, Poland

Location

DERMMEDICA Sp.z o.o.

Wroclaw, 51 503, Poland

Location

Chelyabinsk Regional Clinical Dermatovenerological Dispensary

Chelyabinsk, 454092, Russia

Location

LLC Aliance Biomedical-Ural group

Izhevsk, 426061, Russia

Location

State Budgetary Educational Institution of High Professional Education

Kazan', 420097, Russia

Location

Medical Center LLC Maxsimum Zdoroviya

Kemerovo, 644024, Russia

Location

LLC Family Outpatient Clinic # 4

Moscow, 109044, Russia

Location

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

Moscow, 119049, Russia

Location

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

Moscow, 129110, Russia

Location

FGBU Research Institute of Rheumatology named V.A.Nasonova

Moscow, 190068, Russia

Location

LLC Consultative and Diagnostic Center of Rheumatology Heal

Novosibirsk, 630099, Russia

Location

GBUZ Orenburg Clinical Regional Hospital

Orenburg, 460000, Russia

Location

Republican Hospital n.a.V.A.Baranov

Petrozavodsk, 185019, Russia

Location

Ryazan Regional Clinical Dermatovenerological Dispensary

Ryazan, 390000, Russia

Location

Ryazan Regional Clinical Cardiology Center

Ryazan, 390026, Russia

Location

Ryazan Regional Clinical Hospital

Ryazan, 390026, Russia

Location

Federal North-West Medical Research Centre

Saint Petersburg, 194214, Russia

Location

LLC Sanavita

Saint Petersburg, 195257, Russia

Location

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

Saint Petersburg, 196066, Russia

Location

Sararov Regional Clinical Hospital

Saratov, 410053, Russia

Location

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, 432063, Russia

Location

State Budget Healthcare Institution of Vladimir Region Regional Clinical Hospital

Vladimir, 600023, Russia

Location

Clinical Hospital #3

Yaroslavl, 150007, Russia

Location

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

Yaroslavl, 150054, Russia

Location

Institute Of Rheumatology 1

Belgrade, 11000, Serbia

Location

Institute Of Rheumatology 2

Belgrade, 11000, Serbia

Location

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Institute for Treatment and Rehabilitation Niska Banja

Niška Banja, 18205, Serbia

Location

Special Hospital for Rheumatic Diseases

Novi Sad, 21000, Serbia

Location

Paediatric University Hospital

Košice, 4011, Slovakia

Location

Reumatologicka ambulancia

Martin, 036 01, Slovakia

Location

Chiremed, s.r.o.

Púchov, 020 01, Slovakia

Location

Reumex s.r.o

Rimavská Sobota, Slovakia

Location

Splosna bolnisnica Izola

Izo, 6310, Slovenia

Location

Bolnica Dr. Petra Drzaja

Ljubljana, Slovenia

Location

UKC Maribor Dermatology clinic

Maribor, 2000, Slovenia

Location

Soonchunhyang University Cheonan Hospital

Cheonan-si, 31151, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Hanyang University Hospital

Seoul, 04763, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Seoul National University Hospital

Seoul, 3080, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp Regional Univ de Malaga

Málaga, 29009, Spain

Location

Hosp. Univ. de Mostoles

Móstoles, 28935, Spain

Location

Hosp. Univ. Virgen de La Arrixaca

Murcia, 30120, Spain

Location

Hosp. Univ. Infanta Sofia

San Sebastián de los Reyes, 28702, Spain

Location

Complejo Hospitalario Universitario de Santiago. Servicio de Aparato Digestivo

Santiago de Compostela, 15076, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15702, Spain

Location

Hosp. Nuestra Senora de La Esperanza

Santiago de Compostela, 15705, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Hosp. Infanta Luisa

Seville, 41013, Spain

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Chang Gung Medical Foundation

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Chi Mei Medical Center Yong Kang

Tainan, 710, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

National Taiwan University Hospital 1

Taoyuan District, 30059, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Akdeniz University Medical Faculty

Istanbul, 07070, Turkey (Türkiye)

Location

Izmir Katip Celebi University

Izmir, 35430, Turkey (Türkiye)

Location

Kocaeli University Medical Faculty

Kocaeli, 41000, Turkey (Türkiye)

Location

Selcuk University Medical Faculty

Konya, 42081, Turkey (Türkiye)

Location

Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, 18009, Ukraine

Location

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

Kharkiv, 61039, Ukraine

Location

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

Kharkiv, 61058, Ukraine

Location

Khmelnitska oblasna likarnia

Khmelnitsky, Ukraine

Location

TOV Revmocentr

Kiev, 02081, Ukraine

Location

Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi rady

Kryvyi Rih, Ukraine

Location

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

Kyiv, 03037, Ukraine

Location

Kyiv Railway Station Clinical Hospital #2

Kyiv, 03049, Ukraine

Location

State Institution Railway clinical Hospital 2

Kyiv, 03049, Ukraine

Location

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

Kyiv, 03151, Ukraine

Location

Olexandrivska Clinical Hospital of Kyiv City

Kyiv, 04050, Ukraine

Location

Kyivska oblasna klinichna likarnia

Kyiv, 04106, Ukraine

Location

Center of Family Medicine Plus LLC

Kyiv, 04210, Ukraine

Location

Multidisciplinary Medical Center of Odessa National Medical University

Odesa, 65006, Ukraine

Location

Odeska oblasna klinichna likarnia

Odesa, 65025, Ukraine

Location

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

Poltava, Ukraine

Location

Sumska oblasna klinichna likarnia

Sumy, Ukraine

Location

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

Ternopil, Ukraine

Location

Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

Vinnytsia, 21009, Ukraine

Location

Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]

Vinnytsia, 21029, Ukraine

Location

Zhytomyr Central City Hospital #1

Zhytomyr, 10002, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 36627711 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Executive Medical Director
• Organization: Janssen Research and Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 11, 2021
• Study Start: June 17, 2021
• Primary Completion: December 30, 2024
• Study Completion (Estimated): October 5, 2027
• Last Updated: April 13, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (4); GR (5); CZ (14); BU (15); TU (4); BO (5); TW (8); AU (5); CN (24); PL (17); US (23); GE (12); LA (6); DE (7); KR (7); SL (4); PH (9); CR (6); LI (5); MY (6); ES (12); HU (11); RU (22); SE (7); IL (7); IT (8); UA (21)