A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
NCT ID: NCT04929210
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
405 participants
INTERVENTIONAL
2021-08-30
2027-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: Guselkumab and Placebo
Participants will receive guselkumab and matching placebo subcutaneously (SC) to maintain the blind.
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Placebo
Matching placebo will be administered as subcutaneous injection.
Group 2: Guselkumab
Participants will receive guselkumab SC.
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Group 3: Placebo followed by Guselkumab
Participants will receive matching placebo and will cross over to receive guselkumab SC.
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Placebo
Matching placebo will be administered as subcutaneous injection.
Interventions
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Guselkumab
Guselkumab will be administered as subcutaneous injection.
Placebo
Matching placebo will be administered as subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
* Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac \[SI\] joints, shown by a Spondyloarthritis Research Consortium of Canada \[SPARCC\] score of \>= 3 in either the spine or the sacroiliac joints)
* Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale \[VAS\]) of at least 4
* Have active plaque psoriasis, with at least 1 psoriatic plaque of \>= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
Exclusion Criteria
* Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
* Has previously received any biologic treatment
* Has ever received a Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
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 Zidenice, , 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
Ltd American Hospital Network
T'bilisi, , Georgia
Tbilisi Heart and Vascular Clinic Ltd
T'bilisi, , Georgia
LTD 'Aversi Clinic'
T'bilisi, , Georgia
Clinic on Mtskheta Street
T'bilisi, , Georgia
Aleksandre Aladashvili Clinic LLC
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
LTD MediClub Georgia
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
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
Countries
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Central Contacts
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References
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Gladman DD, Mease PJ, Bird P, Soriano ER, Chakravarty SD, Shawi M, Xu S, Quinn ST, Gong C, Leibowitz E, Poddubnyy D, Tam LS, Helliwell PS, Kavanaugh A, Deodhar A, Ostergaard M, Baraliakos X. Efficacy and safety of guselkumab in biologic-naive patients with active axial psoriatic arthritis: study protocol for STAR, a phase 4, randomized, double-blinded, placebo-controlled trial. Trials. 2022 Sep 5;23(1):743. doi: 10.1186/s13063-022-06589-y.
Other Identifiers
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CNTO1959PSA4002
Identifier Type: OTHER
Identifier Source: secondary_id
2021-000465-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504716-15-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109043
Identifier Type: -
Identifier Source: org_study_id