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ACTIVE NOT RECRUITING
NCT04929210
PHASE4

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.

Official title: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

411

Start Date

2021-08-30

Completion Date

2027-04-13

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Guselkumab

Guselkumab will be administered as subcutaneous injection.

DRUG

Placebo

Matching placebo will be administered as subcutaneous injection.

Locations (240)

Arizona Arthritis and Rheumatology Research PLLC

Avondale, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Chandler, Arizona, United States

Arizona Arthritis and Rheumatology Research PLLC

Mesa, Arizona, United States

Arizona Arthritis Research, PLC.

Phoenix, Arizona, United States

Arizona Arthritis and Rheumatology Associates

Sun City, Arizona, United States

Southern Arizona VA Healthcare System

Tucson, Arizona, United States

Unity Health-White County Medical Center

Searcy, Arkansas, United States

Kaiser Permanent Medical Center

Fontana, California, United States

Newport Huntington Medical Group

Huntington Beach, California, United States

University Of California San Diego

La Jolla, California, United States

Rheumatology Center of San Diego

San Diego, California, United States

Clinical Research Center of Connecticut

Danbury, Connecticut, United States

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Integral Rheumatology And Immunology Specialists

Plantation, Florida, United States

Florida Medical Clinic, P.A.

Zephyrhills, Florida, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

OrthoIllinois

Rockford, Illinois, United States

Willow Rheumatology and Wellness

Willowbrook, Illinois, United States

Johns Hopkins Bayview Medical

Baltimore, Maryland, United States

Klein And Associates M D P A

Hagerstown, Maryland, United States

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, United States

St. Paul Rheumatology P A

Eagan, Minnesota, United States

Kansas City Physician Partners

Kansas City, Missouri, United States

Clinvest

Springfield, Missouri, United States

STAT Research, Inc.

Vandalia, Ohio, United States

OHSU Rheumatology Clinic, Marquam Hill

Portland, Oregon, United States

Amarillo Center for Clinical Research

Amarillo, Texas, United States

Austin Regional Clinic

Austin, Texas, United States

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States

Adriana Pop Moody MD Clinic PA

Corpus Christi, Texas, United States

AARA Clinical Research Lone Star Arthritis and Rheumatology

Fort Worth, Texas, United States

UT Physicians Center for Autoimmunity

Houston, Texas, United States

AARA Clinical Research Lone Star Arthritis and Rheumatology

Irving, Texas, United States

West Texas Clinical Research

Lubbock, Texas, United States

Southwest Rheumatology Research LLC

Mesquite, Texas, United States

Epic Medical Research

Red Oak, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Cosultorios Reumatologógicos Pampa

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Centro Privado de Medicina Familiar

Buenos Aires, Argentina

Hospital Italiano La Plata

La Plata, Argentina

MR Medicina Reumatologica

San Fernando, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Argentina

Emeritus Research

Camberwell, Australia

Southern Clinical Research

Hobart, Australia

Liverpool Hospital

Liverpool, Australia

Rheumatology Research Unit

Maroochydore, Australia

Skin Health Institute Inc.

Melbourne, Australia

Eastern Health - Box Hill Hospital

Melbourne, Australia

Exacta Medica

Pleven, Bulgaria

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, Bulgaria

Medical Center Unimed Plovdiv

Plovdiv, Bulgaria

UMHAT Kaspela

Plovdiv, Bulgaria

Medical Center Artmed

Plovdiv, Bulgaria

MHAT 'Lyulin' EAD

Sofia, Bulgaria

University Multiprofile Hospital Sofiamed Sofia

Sofia, Bulgaria

Military Medical Academy

Sofia, Bulgaria

UMHAT St. Ivan Rilski

Sofia, Bulgaria

DCC Convex EOOD

Sofia, Bulgaria

ASIMP Rheumatology Centre St Irina EOOD

Sofia, Bulgaria

Medical Centre Synexus

Sofia, Bulgaria

DDC Sv. Ivan Rilski OOD

Targovishte, Bulgaria

Skin Care Centre

Vancouver, British Columbia, Canada

Eastern Regional Health Authority St Clares Mercy Hospital

St. John's, Newfoundland and Labrador, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

G R M O Groupe de recherche en maladies osseuses Inc

Québec, Quebec, Canada

Revmaclinic

Brno, Czechia

Revmatologie s r o

Brno, Czechia

Revmacentrum MUDr Mostera s r o

Brno-Židenice, Czechia

L K N Arthrocentrum

Hlučín, Czechia

Revimex Pro s r o

Karvina Frystat, Czechia

MUDr Rosypalova s r o

Ostrava, Czechia

Arthrohelp S.R.O.

Pardubice, Czechia

Revmatologicky ustav

Prague, Czechia

Medical Plus S R O

Uherské Hradiště, Czechia

Frederiksberg Hospital

Frederiksberg, Denmark

Rigshospitalet Glostrup

Glostrup Municipality, Denmark

Køge Sygehus Region Sjaelland

Køge, Denmark

Vejle Sygehus

Vejle, Denmark

Ltd Health Center

Batumi, Georgia

LTD Clinic LJ

Kutaisi, Georgia

Aleksandre Aladashvili Clinic LLC

Tbilisi, Georgia

Ltd American Hospital Network

Tbilisi, Georgia

LTD Helsicore

Tbilisi, Georgia

Ltd New Hospitals

Tbilisi, Georgia

TSMU The First University Clinic

Tbilisi, Georgia

JSC K Eristavi National Center of experimental and Clinical surgery

Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic Ltd

Tbilisi, Georgia

LTD 'Aversi Clinic'

Tbilisi, Georgia

LTD MediClub Georgia

Tbilisi, Georgia

Clinic on Mtskheta Street

Tbilisi, Georgia

LTD The First Medical Center

Tbilisi, Georgia

Consilium Medulla-multiprofile clinic Ltd

Tbilisi, Georgia

JSC Evex Hospitals

Tnilisi, Georgia

ISA - Interdisciplinary Study Association GmbH

Berlin, Germany

Hamburger Rheuma Forschungszentrum II

Hamburg, Germany

Rheumazentrum Ruhrgebiet

Herne, Germany

Rheumazentrum Ratingen

Ratingen, Germany

Prince Of Wales Hospital

Hong Kong, Hong Kong

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

Budapest, Hungary

Obudai Egeszsegugyi Centrum Kft

Budapest, Hungary

Qualiclinic Kft

Budapest, Hungary

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, Hungary

Porcika Klinika - Vasarhelyi Sarkanyfu Kft.

Hódmezővásárhely, Hungary

Kistarcsai Flor Ferenc Korhaz

Kistarcsa, Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Székesfehérvár, Hungary

Vital Medical Center Orvosi es Fogaszati Kozpont

Veszprém, Hungary

Bnai Zion Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Wolfson Medical Center

Holon, Israel

Meir Medical Center

Kfar Saba, Israel

Sheba Medical Center

Ramat Gan, Israel

A.O. Universitaria Ospedali Riuniti di Ancona

Ancona, Italy

Azienda Ospedaliero-Universitaria di Cagliari

Monserrato, Italy

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, Italy

Policlinico Tor Vergata

Roma, Italy

Humanitas Hospital

Rozzano (MI), Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Hospital Selayang

Batu Caves, Malaysia

Hospital Pulau Pinang

George Town, Malaysia

Hospital Sultan Ismail

Johor Bahru, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Hospital Tuanku Jaafar

Seremban, Malaysia

Cebu Doctors' University Hospital

Cebu City, Philippines

Davao Doctors Hospital

Davao City, Philippines

Lipa Medix Medical Hospital

Lipa, Philippines

ManilaMed Medical Center Manila

Manila, Philippines

Philippine General Hospital

Manila, Philippines

St. Luke's Medical Center

Quezon City, Philippines

Ilocos Training and Regional Medical Center

San Fernando City, Philippines

ClinicMed Daniluk Nowak Spolka Komandytowa

Bialystok, Poland

Szpital Uniwersytecki nr 2 im dr Jana Biziela

Bydgoszcz, Poland

Nzoz Bif Med

Bytom, Poland

Ambulatorium sp. z o.o.

Elblag, Poland

Centrum Kliniczno Badawcze

Elblag, Poland

Malopolskie Badania Kliniczne Sp z o o

Krakow, Poland

Centrum Medyczne Promed

Krakow, Poland

Dermed Centrum Medyczne Sp z o o

Lodz, Poland

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, Poland

Centrum Medyczne AMED oddzial w Lodzi

Lodz, Poland

Velocity Lublin

Lublin, Poland

Reumed Zespol Poradni Specjalistycznych Filia nr 1

Lublin, Poland

Pro Life Medica Sp. z o.o.

Lublin, Poland

NZOZ Lecznica MAK MED S C

Nadarzyn, Poland

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, Poland

Twoja Przychodnia PCM

Poznan, Poland

Reumedika s c Wieslawa Porawska Lukasz Porawski

Poznan, Poland

Lubelskie Centrum Diagnostyczne

Świdnik, Poland

MICS Centrum Medyczne Torun

Torun, Poland

MICS Centrum Medyczne Warszawa

Warsaw, Poland

Rheuma Medicus Sp z o o

Warsaw, Poland

Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

Warsaw, Poland

Centrum Medyczne Reuma Park

Warsaw, Poland

ETG Warszawa

Warsaw, Poland

Centrum Medyczne AMED Targowek

Warsaw, Poland

WroMedica I Bielicka A Strzalkowska s c

Wroclaw, Poland

Uls Braga - Hosp. Braga

Braga, Portugal

Ulsg - Hosp. Sousa Martins

Guarda, Portugal

Ipr Inst Port de Reumatologia

Lisbon, Portugal

Uls Lisboa Ocidental - Hosp. Egas Moniz

Lisbon, Portugal

Hosp. Cuf Tejo

Lisbon, Portugal

Uls Santa Maria - Hosp. Santa Maria

Lisbon, Portugal

Ulsam - Hosp. Conde de Bertiandos

Ponte de Lima, Portugal

Uls Sao Joao - Hosp. Sao Joao

Porto, Portugal

Altay Medical State University

Barnaul, Russia

Chelyabinck Regional Clinical Hospital

Chelyabinsk, Russia

Chelyabinsk Regional Clinical Dermatovenerological Dispensary

Chelyabinsk, Russia

Regional Clinical Diagnostic Center of Udmurtia Region

Izhevsk, Russia

LLL Medical Center Revma-Med

Kemerovo, Russia

LLC Family Outpatient Clinic # 4

Korolyov, Russia

Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon

Krasnoyarsk, Russia

Clinical-Diagnostic Center Euromedservice, JSC

Moscow, Russia

FGBU Research Institute of Rheumatology named V.A.Nasonova

Moscow, Russia

GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'

Moscow, Russia

Llc Ultramed

Omsk, Russia

GBOU VPO Orenburg State Medical University

Orenburg, Russia

GBUZ Perm Regional Clinical Hospital

Perm, Russia

Republican Hospital n.a.V.A.Baranov

Petrozavodsk, Russia

Rostov Regional Clinical Dermatovenerological Dispensary

Rostov, Russia

St. Petersburg GBUZ Clinical Reumatological Hospital 25

Saint Petersburg, Russia

X7 Clinical Research Company Limited

Saint Petersburg, Russia

GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'

Tolyatti, Russia

Republican Clinical Hospital - G.G. Kuvatov

Ufa, Russia

Clinical Hospital #3

Yaroslavl, Russia

Sverdlovsk Regional Clinical Hospital N. 1

Yekaterinburg, Russia

Reumatologicka ambulancia

Martin, Slovakia

Reumatologicka ambulancia

Nové Mesto nad Váhom, Slovakia

Reumatologická ambulancia Thermium s.r.o.

Piešťany, Slovakia

REUMAMED POPRAD, s.r.o.

Poprad, Slovakia

Reumex s.r.o

Rimavská Sobota, Slovakia

Hosp Univ A Coruna

A Coruña, Spain

Hosp. Univ. de Cruces

Barakaldo, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp. Univ. de Basurto

Bilbao, Spain

Hosp Reina Sofia

Córdoba, Spain

Hosp. Clinico San Carlos

Madrid, Spain

Hosp Regional Univ de Malaga

Málaga, Spain

Corporacio Sanitari Parc Tauli

Sabadell, Spain

Clinica Gaias

Santiago de Compostela, Spain

Hosp. Virgen Macarena

Seville, Spain

Hosp. Quiron Sagrado Corazon

Seville, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Karolinska Universitetssjukhuset

Solna, Sweden

Akademiska Sjukhuset

Uppsala, Sweden

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taoyuan District, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Phramongkutklao Hospital and Medical College

Bangkok, Thailand

Ramathibodi Hospital Mahidol University

Bangkok, Thailand

Chiang Mai University

Chiang Mai, Thailand

Adana City Hospital

Adana, Turkey (Türkiye)

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Uludag University Medical Faculty

Bursa, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Marmara University Medical Faculty

Istanbul, Turkey (Türkiye)

Necmettin Erbakan University Meram Medical Faculty

Konya, Turkey (Türkiye)

Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, Ukraine

Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital

Kharkiv, Ukraine

Khmelnitckiy regional hospital

Khmelnytsky, Ukraine

City Clinical Hospital No. 2

Kryvyi Rih, Ukraine

Medical Center of 'Institute of Rheumatology', LLC

Kyiv, Ukraine

Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

Kyiv, Ukraine

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

Kyiv, Ukraine

Volyn Regional Clinical Hospital

Lutsk, Ukraine

Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

Odesa, Ukraine

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

Poltava, Ukraine

Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

Ternopil, Ukraine

Health Clinic Limited Liability Company

Vinnytsia, Ukraine

Medical Center LLC 'Modern Clinic'

Zaporizhzhya, Ukraine

Royal Free London NHS Foundation Trust

Barnet, United Kingdom

St. Lukes Hospital

Bradford, United Kingdom

University Hospital Coventry & Warwickshire NHS Trust

Coventry, United Kingdom

Chapel Allerton Hospital

Leeds, United Kingdom

Central Manchester University Hospitals NHS Foundation Trust

Manchester, United Kingdom

North Tyneside General Hospital

Newcastle, United Kingdom

Haywood Hospital

Stoke-on-Trent, United Kingdom