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

April 23, 2024 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin (Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production. This study will consist of a screening phase (up to 6 weeks), a treatment phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up phase (up to Week 60). The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments will include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events. The overall duration of the study will be up to 14 months.

Study Type

Interventional

Enrollment (Estimated)

405

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, 1428
        • Recruiting
        • Cosultorios Reumatologógicos Pampa
      • Buenos Aires, Argentina, C1417
        • Recruiting
        • Centro Privado de Medicina Familiar
      • La Plata, Argentina, B1900
        • Recruiting
        • Hospital Italiano La Plata
  • Australia
      • Camberwell, Australia, 3124
        • Completed
        • Emeritus Research
      • Hobart, Australia, 7000
        • Recruiting
        • Southern Clinical Research
      • Liverpool, Australia, 2170
        • Completed
        • Liverpool Hospital
      • Maroochydore, Australia, 4558
        • Terminated
        • Rheumatology Research Unit
      • Melbourne, Australia, 3053
        • Terminated
        • Skin Health Institute Inc.
      • Melbourne, Australia, 3128
        • Completed
        • Eastern Health - Box Hill Hospital
  • Bulgaria
      • Pleven, Bulgaria, 5803
        • Recruiting
        • Exacta Medica
      • Pleven, Bulgaria, 5804
        • Recruiting
        • UMHAT 'Dr. Georgi Stranski', EAD
      • Plovdiv, Bulgaria, 4001
        • Recruiting
        • Medical Center Unimed Plovdiv
      • Plovdiv, Bulgaria, 4001
        • Recruiting
        • UMHAT Kaspela
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • Medical Center Artmed
      • Sfia, Bulgaria, 1612
        • Recruiting
        • UMHAT St. Ivan Rilski
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Military Medical Academy
      • Sofia, Bulgaria, 1794
        • Recruiting
        • Medical Centre Synexus
      • Sofia, Bulgaria, 1336
        • Recruiting
        • MHAT 'Lyulin' EAD
      • Sofia, Bulgaria, 1680
        • Recruiting
        • DCC Convex EOOD
      • Sofia, Bulgaria, 1336
        • Completed
        • University Multiprofile Hospital Sofiamed Sofia
      • Sofia, Bulgaria, 1750
        • Recruiting
        • ASIMP Rheumatology Centre St Irina EOOD
      • Targovishte, Bulgaria, 7700
        • Recruiting
        • DDC Sv. Ivan Rilski OOD
  • Canada
      • Quebec, Canada, G1V 3M7
        • Recruiting
        • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • Recruiting
        • Skin Care Centre
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • Recruiting
        • Eastern Regional Health Authority, St. Clare's Mercy Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
  • Czechia
      • Brno, Czechia, 61141
        • Completed
        • Revmaclinic
      • Brno, Czechia, 63800
        • Completed
        • Revmatologie s r o
      • Brno Zidenice, Czechia, 615 00
        • Recruiting
        • Revmacentrum MUDr Mostera s r o
      • Hlucin, Czechia, 748 01
        • Recruiting
        • L K N Arthrocentrum
      • Ostrava, Czechia, 70800
        • Recruiting
        • MUDr Rosypalova s r o
      • Pardubice, Czechia, 53002
        • Recruiting
        • Arthrohelp S.R.O.
      • Praha, Czechia, 128 00
        • Recruiting
        • Revmatologicky ustav
      • Uherske Hradiste, Czechia, 68601
        • Recruiting
        • Medical Plus S R O
  • Denmark
      • Frederiksberg, Denmark, 2000
        • Recruiting
        • Frederiksberg Hospital
      • Glostrup, Denmark, 2600
        • Recruiting
        • Rigshospitalet Glostrup
      • Køge, Denmark, 4600
        • Recruiting
        • Køge Sygehus Region Sjaelland
      • Vejle, Denmark, 7100
        • Recruiting
        • Vejle Sygehus
  • Georgia
      • Kutaisi, Georgia, 4600
        • Recruiting
        • LTD Clinic LJ
      • T'bilisi, Georgia, 0159
        • Recruiting
        • Tbilisi Heart and Vascular Clinic Ltd
      • T'bilisi, Georgia, 0102
        • Recruiting
        • Ltd American Hospital Network
      • T'bilisi, Georgia, 0179
        • Recruiting
        • Clinic on Mtskheta Street
      • T'bilisi, Georgia, 0160
        • Recruiting
        • LTD 'Aversi Clinic'
      • Tbilisi, Georgia, 0160
        • Recruiting
        • LTD MediClub Georgia
      • Tbilisi, Georgia, 0102
        • Recruiting
        • Aleksandre Aladashvili Clinic LLC
      • Tbilisi, Georgia, 0186
        • Recruiting
        • Consilium Medulla-multiprofile clinic Ltd
      • Tbilisi, Georgia, 0114
        • Recruiting
        • Ltd New Hospitals
      • Tbilisi, Georgia, 0180
        • Recruiting
        • LTD The First Medical Center
      • Tbilisi, Georgia, 0112
        • Recruiting
        • LTD Helsicore
      • Tbilisi, Georgia, 0141
        • Recruiting
        • TSMU The First University Clinic
      • Tnilisi, Georgia, 0159
        • Recruiting
        • JSC Evex Hospitals
  • Germany
      • Berlin, Germany, 10789
        • Recruiting
        • ISA - Interdisciplinary Study Association GmbH
      • Hamburg, Germany, 20095
        • Completed
        • Hamburger Rheuma Forschungszentrum II
      • Herne, Germany, 44649
        • Recruiting
        • Rheumazentrum Ruhrgebiet
      • Ratingen, Germany, 40878
        • Completed
        • Rheumazentrum Ratingen
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital
  • Hungary
      • Budapest, Hungary, 1023
        • Recruiting
        • Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz
      • Budapest, Hungary, 1036
        • Recruiting
        • Obudai Egeszsegugyi Centrum Kft
      • Budapest, Hungary, H-1036
        • Recruiting
        • Qualiclinic Kft
      • Gyula, Hungary, 5700
        • Recruiting
        • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
      • Kistarcsa, Hungary, 2143
        • Recruiting
        • Kistarcsai Flor Ferenc Korhaz
      • Székesfehérvár, Hungary, 8000
        • Recruiting
        • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
      • Veszprem, Hungary, 8200
        • Recruiting
        • Vital Medical Center Orvosi es Fogaszati Kozpont
  • Israel
      • Haifa, Israel, 31048
        • Recruiting
        • Bnai Zion Medical Center
      • Hifa, Israel, 34362
        • Recruiting
        • Carmel Medical Center
      • Kfar-Sava, Israel, 4428164
        • Completed
        • Meir Medical Center
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center
  • Italy
      • Ancona, Italy, 60126
        • Recruiting
        • A.O. Universitaria Ospedali Riuniti di Ancona
      • Monserrato, Italy, 09124
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Cagliari
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Arcispedale Santa Maria Nuova - IRCCS
      • Roma, Italy, 00133
        • Recruiting
        • Policlinico Tor Vergata
      • Rozzano (MI), Italy, 20089
        • Recruiting
        • Humanitas Hospital
      • Verona, Italy, 37126
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
  • Malaysia
      • Batu Caves, Malaysia, 68100
        • Recruiting
        • Hospital Selayang
      • George Town, Malaysia, 10990
        • Recruiting
        • Hospital Pulau Pinang
      • Johor Bahru, Malaysia, 81100
        • Recruiting
        • Hospital Sultan Ismail
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre
      • Seremban, Malaysia, 70300
        • Recruiting
        • Hospital Tuanku Jaafar
  • Philippines
      • Cebu City, Philippines, 6000
        • Recruiting
        • Cebu Doctors' University Hospital
      • Davao City, Philippines, 8000
        • Recruiting
        • Davao Doctors Hospital
      • Lipa, Philippines, 4217
        • Recruiting
        • Lipa Medix Medical Hospital
      • Manila, Philippines, 1000
        • Recruiting
        • ManilaMed Medical Center Manila
      • San Fernando, Philippines, 2500
        • Recruiting
        • Ilocos Training and Regional Medical Center
  • Poland
      • Bialystok, Poland, 15 879
        • Recruiting
        • ClinicMed Daniluk Nowak Spolka Komandytowa
      • Bydgoszcz, Poland, 85-168
        • Recruiting
        • Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
      • Bytom, Poland, 41-902
        • Recruiting
        • Nzoz Bif Med
      • Elblag, Poland, 82-300
        • Recruiting
        • Centrum Kliniczno Badawcze
      • Elblag, Poland, 82 300
        • Recruiting
        • Ambulatorium sp. z o.o.
      • Krakow, Poland, 31-513
        • Recruiting
        • Centrum Medyczne Promed
      • Krakow, Poland, 30 002
        • Recruiting
        • Malopolskie Badania Kliniczne Sp z o o
      • Lodz, Poland, 91-363
        • Recruiting
        • Centrum Medyczne AMED oddzial w Lodzi
      • Lodz, Poland, 90-338
        • Recruiting
        • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
      • Lodz, Poland, 90 265
        • Recruiting
        • Dermed Centrum Medyczne Sp z o o
      • Lublin, Poland, 20-362
        • Recruiting
        • KO-MED Centra Kliniczne LUBLIN
      • Lublin, Poland, 20-412
        • Recruiting
        • Pro Life Medica Sp. z o.o.
      • Nadarzyn, Poland, 05 830
        • Recruiting
        • NZOZ Lecznica MAK MED S C
      • Nowa Sol, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia - Centrum Medyczne Nowa Sol
      • Poznan, Poland, 61-293
        • Recruiting
        • Twoja Przychodnia Poznanskie Centrum Medyczne
      • Poznan, Poland, 60-446
        • Recruiting
        • Reumedika s c Wieslawa Porawska Lukasz Porawski
      • Swidnik, Poland, 21-040
        • Recruiting
        • Lubelskie Centrum Diagnostyczne
      • Torun, Poland, 87-100
        • Recruiting
        • MICS Centrum Medyczne Torun
      • Warsaw, Poland, 00-874
        • Recruiting
        • MICS Centrum Medyczne Warszawa
      • Warsaw, Poland, 02 637
        • Recruiting
        • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
      • Warszawa, Poland, 02-665
        • Recruiting
        • Centrum Medyczne Reuma Park
      • Warszawa, Poland, 02-118
        • Recruiting
        • Rheuma-Medicus Sp. z o.o.
      • Warszawa, Poland, 02-793
        • Completed
        • ETG Warszawa
      • Warszawa, Poland, 03-291
        • Recruiting
        • Centrum Medyczne AMED Targowek
      • Wrocław, Poland, 51-685
        • Recruiting
        • WroMedica I.Bielicka, A.Strzałkowska s.c.
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • Ccab - Hosp. de Braga
      • Guarda, Portugal, 6300-749
        • Recruiting
        • Ulsg - Hosp. Sousa Martins
      • Lisboa, Portugal, 1649-035
        • Recruiting
        • Chln - Hosp. Santa Maria
      • Lisboa, Portugal, 1050-034
        • Recruiting
        • Ipr - Inst. Port. de Reumatologia
      • Lisboa, Portugal, 1350-352
        • Completed
        • Hospital CUF Tejo
      • Lisboa, Portugal, 1349-019
        • Recruiting
        • Chlo Hosp Egas Moniz
      • Ponte de Lima, Portugal, 4990-041
        • Recruiting
        • Ulsam - Hosp. Conde de Bertiandos
      • Porto, Portugal, 4200-319
        • Recruiting
        • Chsj - Hosp. Sao Joao
  • Russian Federation
      • Barnaul, Russian Federation, 656038
        • Completed
        • Altay Medical State University
      • Chelyabinsk, Russian Federation, 454076
        • Terminated
        • Chelyabinck Regional Clinical Hospital
      • Chelyabinsk, Russian Federation, 454092
        • Completed
        • Chelyabinsk Regional Clinical Dermatovenerological Dispensary
      • Ekaterinbourg, Russian Federation, 620102
        • Terminated
        • Sverdlovsk Regional Clinical Hospital N. 1
      • Izhevsk, Russian Federation, 426009
        • Completed
        • Regional Clinical Diagnostic Center of Udmurtia Region
      • Kemerovo, Russian Federation, 650070
        • Completed
        • LLL Medical Center Revma-Med
      • Korolev, Russian Federation, 141060
        • Completed
        • LLC Family Outpatient Clinic # 4
      • Krasnoyarsk, Russian Federation, 660123
        • Terminated
        • Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
      • Moscow, Russian Federation, 129110
        • Completed
        • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
      • Moscow, Russian Federation, 115419
        • Completed
        • Clinical-Diagnostic Center Euromedservice, JSC
      • Moscow, Russian Federation, 115522
        • Completed
        • FGBU Research Institute of Rheumatology named V.A.Nasonova
      • Omsk, Russian Federation, 644024
        • Completed
        • Llc Ultramed
      • Orenburg, Russian Federation, 460000
        • Terminated
        • GBOU VPO Orenburg State Medical University
      • Perm, Russian Federation, 614990
        • Terminated
        • GBUZ Perm Regional Clinical Hospital
      • Petrozavodsk, Russian Federation, 185019
        • Completed
        • Republican Hospital n.a.V.A.Baranov
      • Rostov, Russian Federation, 344007
        • Completed
        • Rostov Regional Clinical Dermatovenerological Dispensary
      • St. Petersburg, Russian Federation, 194156
        • Terminated
        • X7 Clinical Research Company Limited
      • St. Petersburg, Russian Federation, 190068
        • Completed
        • St. Petersburg GBUZ Clinical Reumatological Hospital 25
      • Tolyatti, Russian Federation, 445846
        • Completed
        • GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
      • Ufa, Russian Federation, 450005
        • Completed
        • Republican Clinical Hospital - G.G. Kuvatov
      • Yaroslavl, Russian Federation, 150007
        • Completed
        • Clinical Hospital #3
  • Slovakia
      • Martin, Slovakia, 036 01
        • Recruiting
        • Reumatologicka ambulancia
      • Nove Mesto nad Vahom, Slovakia, 91501
        • Recruiting
        • Reumatologicka ambulancia
      • Piestany, Slovakia, 921 01
        • Recruiting
        • Reumatologická ambulancia Thermium s.r.o.
      • Poprad, Slovakia, 05801
        • Recruiting
        • REUMAMED POPRAD, s.r.o.
      • Rimavska Sobota, Slovakia
        • Recruiting
        • Reumex s.r.o
  • Spain
      • A Coruna, Spain, 15006
        • Recruiting
        • Hosp. Univ. A Coruna
      • Barakaldo, Spain, 48902
        • Recruiting
        • Hosp. Univ. de Cruces
      • Barcelona, Spain, 08036
        • Recruiting
        • Hosp. Clinic de Barcelona
      • Bilbao, Spain, 48013
        • Recruiting
        • Hosp. Univ. de Basurto
      • Cordoba, Spain, 14004
        • Recruiting
        • Hosp. Reina Sofia
      • Madrid, Spain, 28040
        • Completed
        • Hosp. Clinico San Carlos
      • Málaga, Spain, 29009
        • Recruiting
        • Hosp. Regional Univ. de Malaga
      • Sabadell, Spain, 8208
        • Recruiting
        • Corporacio Sanitari Parc Tauli
      • Santiago de Compostela, Spain, 15702
        • Recruiting
        • Clinica Gaias
      • Sevilla, Spain, 41009
        • Recruiting
        • Hosp. Virgen Macarena
      • Sevilla, Spain, 41013
        • Recruiting
        • Hosp. Quiron Sagrado Corazon
      • Valencia, Spain, 46026
        • Recruiting
        • Hosp. Univ. I Politecni La Fe
  • Sweden
      • Solna, Sweden, 171 76
        • Recruiting
        • Karolinska Universitetssjukhuset
      • Uppsala, Sweden, 753 09
        • Recruiting
        • Akademiska Sjukhuset
  • Taiwan
      • Hsin Chu, Taiwan, 30059
        • Recruiting
        • National Taiwan University Hospital
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Linkou Chang Gung Memorial Hospital
  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Phramongkutklao Hospital and Medical College
      • Bangkok, Thailand, 10400
        • Recruiting
        • Ramathibodi Hospital, Mahidol University
      • Chiangmai, Thailand, 50200
        • Recruiting
        • Chiang Mai University
  • Turkey
      • Adana, Turkey, 01370
        • Recruiting
        • Adana City Hospital
      • Ankara, Turkey, 06010
        • Recruiting
        • Gulhane Training and Research Hospital
      • Ankara, Turkey, 06800
        • Completed
        • Ankara Bilkent City Hospital
      • Ankara, Turkey, 6100
        • Completed
        • Hacettepe University Medical Faculty
      • Antalya, Turkey, 7059
        • Recruiting
        • Akdeniz University Medical Faculty
      • Bursa, Turkey, 16059
        • Recruiting
        • Uludag University Medical Faculty
      • Istanbul, Turkey, 34899
        • Recruiting
        • Marmara University Medical Faculty
      • Istanbul, Turkey, 34098
        • Recruiting
        • Istanbul University Cerrahpasa Medical Faculty
      • Konya, Turkey, 42080
        • Recruiting
        • Necmettin Erbakan University Meram Medical Faculty
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Terminated
        • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
      • Kharkiv, Ukraine, 61204
        • Completed
        • Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
      • Khmelnytsky, Ukraine, 29000
        • Terminated
        • Khmelnitckiy regional hospital
      • Kryvyi Rih, Ukraine, 50056
        • Terminated
        • City Clinical Hospital No. 2
      • Kyiv, Ukraine, 02081
        • Terminated
        • Medical Center of 'Institute of Rheumatology', LLC
      • Kyiv, Ukraine, 03049
        • Completed
        • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
      • Kyiv, Ukraine, 03680
        • Completed
        • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
      • Lutsk, Ukraine, 43005
        • Completed
        • Volyn Regional Clinical Hospital
      • Odessa, Ukraine, 65025
        • Terminated
        • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
      • Poltava, Ukraine, 36011
        • Terminated
        • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
      • Ternopil, Ukraine, 46002
        • Completed
        • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
      • Vinnytsia, Ukraine, 21009
        • Terminated
        • Health Clinic Limited Liability Company
      • Zaporizhzhya, Ukraine, 69600
        • Terminated
        • Medical Center LLC 'Modern Clinic'
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Recruiting
        • Royal Free London NHS Foundation Trust
      • Bradford, United Kingdom, BD5 0NA
        • Recruiting
        • St. Lukes Hospital
      • Coventry, United Kingdom, CV2 2DX
        • Recruiting
        • University Hospital Coventry & Warwickshire NHS Trust
      • Leeds, United Kingdom, LS7 4SA
        • Recruiting
        • Chapel Allerton Hospital
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Central Manchester University Hospitals NHS Foundation Trust
      • Newcastle, United Kingdom, NE29 8NH
        • Recruiting
        • North Tyneside General Hospital
      • Stoke on Trent, United Kingdom, ST6 7AG
        • Recruiting
        • Haywood Hospital
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Recruiting
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Mesa, Arizona, United States, 85210
        • Recruiting
        • Arizona Arthritis and Rheumatology Research PLLC
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Arizona Arthritis Research, PLC.
      • Phoenix, Arizona, United States, 85037
        • Recruiting
        • Arizona Arthritis and Rheumatology Research PLLC
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Arizona Arthritis and Rheumatology Associates
      • Tucson, Arizona, United States, 85723
        • Recruiting
        • Southern Arizona VA Healthcare System
    • Arkansas
      • Searcy, Arkansas, United States, 72143
        • Recruiting
        • Unity Health-White County Medical Center
    • California
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Newport Huntington Medical Group
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Completed
        • Clinical Research Center of Connecticut
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Recruiting
        • Bay Pines VA Healthcare System
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Integral Rheumatology And Immunology Specialists
      • Zephyrhills, Florida, United States, 33542
        • Completed
        • Florida Medical Clinic, P.A.
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Great Lakes Clinical Trials
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • RC Research
      • Rockford, Illinois, United States, 61114
        • Recruiting
        • OrthoIllinois
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Completed
        • Klein And Associates M D P A
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48081
        • Recruiting
        • Clinical Research Institute of Michigan, LLC
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Recruiting
        • St. Paul Rhuematology P A
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Clinvest
    • Ohio
      • Vandalia, Ohio, United States, 45377
        • Completed
        • STAT Research, Inc.
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU Rheumatology Clinic, Marquam Hill
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Amarillo Center for Clinical Research
      • Austin, Texas, United States, 78731
        • Completed
        • Austin Regional Clinic
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • Precision Comprehensive Clinical Research Solutions
      • Corpus Christi, Texas, United States, 78404
        • Completed
        • Adriana Pop Moody MD Clinic PA
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Physicians Center for Autoimmunity
      • Lubbock, Texas, United States, 79424
        • Recruiting
        • West Texas Clinical Research
      • Mesquite, Texas, United States, 75150
        • Completed
        • Southwest Rheumatology Research LLC
      • Red Oak, Texas, United States, 75154
        • Recruiting
        • Epic Medical Research
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening
  • 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 known allergies, hypersensitivity, or intolerance to guselkumab 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), 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2: Guselkumab
Participants will receive guselkumab SC.
Drug: Guselkumab
Guselkumab will be administered as subcutaneous injection.
Other Names:
  • TREMFYA
Experimental: Group 1: Guselkumab and Placebo
Participants will receive guselkumab and matching placebo subcutaneously (SC) to maintain the blind.
Drug: Guselkumab
Guselkumab will be administered as subcutaneous injection.
Other Names:
  • TREMFYA
Drug: Placebo
Matching placebo will be administered as subcutaneous injection.
Experimental: Group 3: Placebo followed by Guselkumab
Participants will receive matching placebo and will cross over to receive guselkumab SC.
Drug: Guselkumab
Guselkumab will be administered as subcutaneous injection.
Other Names:
  • TREMFYA
Drug: Placebo
Matching placebo will be administered as subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24
Time Frame: Baseline and Week 24
BASDAI is a self-assessment tool that consists of 6 questions relating to 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. First 5 items were scored on a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 equals to (=) none to 10=very severe. Quantitative morning stiffness was scored on a 10 cm VAS ranging from 0=0 hours to 10=2 or more hours. 2 scores for qualitative and quantitative morning stiffness were averaged, and total BASDAI score was average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity.
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at Week 24
Time Frame: Baseline and Week 24
The ASDAS-CRP is a composite of 5 disease activity variables with only partial overlap. The 4 self-reported items included in this index are back pain (VAS), duration of morning stiffness, peripheral pain/swelling, and participant global assessment of disease activity; these are combined with the C-reactive protein (CRP) value. Selected cut-offs for improvement scores are: a change greater than or equal to (>=) 1.1 units for "clinically important improvement" and a change >= 2.0 units for "major improvement.
Baseline and Week 24
Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 24
Time Frame: Baseline and Week 24
DAPSA assessed the joint domain of psoriatic arthritis (PsA) and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (milligram/deciliter [mg/dL], value less than [<] lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), participant assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
Baseline and Week 24
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
Time Frame: Baseline and Week 24
HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.
Baseline and Week 24
Percentage of Participants with Investigator's Global Assessment (IGA) 0/1 Response at Week 24 among Participants with >= 3% Body Surface Area (BSA) Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Time Frame: Week 24
Percentage of participants with IGA 0/1 response at week 24 among the participants with >= 3 percent (%) BSA psoriatic involvement and an IGA score of >= 2 (mild) at baseline will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given timepoint. Overall lesions are graded for induration, erythema, and scaling using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate) and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Week 24
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints at Week 24
Time Frame: Baseline and Week 24
Change from baseline in SPARCC score for MRI SI joints at week 24 among the participants with a positive MRI of the sacroiliac joints at baseline will be reported. SPARCC method focuses on the cartilaginous portion of the SI joint, and scores presence (score of 1) versus absence (score of 0) of bone marrow edema in each SI joint quadrant.
Baseline and Week 24
Percentage of Participants who Achieve a >= 50 % Improvement from Baseline in BASDAI Score at Week 24
Time Frame: Baseline and Week 24
Percentage of participants who achieve a >= 50 % improvement from baseline in BASDAI score at week 24 will be reported.
Baseline and Week 24
Percentage of Participants who Achieve ASDAS Clinically Important Improvement at Week 24
Time Frame: Week 24
Percentage of participants who achieve ASDAS clinically important improvement at week 24 will be reported.
Week 24
Percentage of Participants who Achieve Ankylosing Spondylitis Activity Score (ASAS) 40 Response at Week 24
Time Frame: Week 24
Percentage of participants who achieve ASAS 40 response at Week 24 will be reported. ASAS 40 defined as improvement from baseline of >= 40% and with an absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Participant's global assessment (0 to 10 cm; 0=very well, 10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none, 10=very severe); no worsening at all from baseline in remaining domain.
Week 24
Percentage of Participants who Achieve ASDAS Major Improvement at Week 24
Time Frame: Week 24
Percentage of participants who achieve ASDAS major improvement at Week 24 will be reported.
Week 24
Change from Baseline in SPARCC Score for MRI Spine at Week 24
Time Frame: Baseline and Week 24
Change from baseline in SPARCC score for MRI spine at week 24 among the participants with a positive MRI of the spine at baseline will be reported. The SPARCC scoring system for the spine scores the 6 discovertebral units considered by the reader as the most abnormal, and then separately assesses each quadrant of 3 adjacent sagittal slices, with additional points for "depth" and high "intensity" of the lesion.
Baseline and Week 24
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 60 weeks
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 60 weeks
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to 60 weeks
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Up to 60 weeks
Number of Participants with Reasonably Related AEs
Time Frame: Up to 60 weeks
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 60 weeks
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Time Frame: Up to 60 weeks
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Up to 60 weeks
Number of Participants with Infections
Time Frame: Up to 60 weeks
Number of participants with infections will be reported.
Up to 60 weeks
Number of participants with Injection-Site Reactions
Time Frame: Up to 60 weeks
Number of participants with injection-site reactions will be reported. A study intervention injection-site reaction is any adverse reaction at a subcutaneous study intervention injection-site.
Up to 60 weeks
Number of Participants with Laboratory Abnormalities (Chemistry, Hematology) by Maximum Toxicity (Common Terminology Criteria for Adverse Events [CTCAE 5.0]) Grades
Time Frame: Up to 60 weeks
Number of participants with laboratory abnormalities (chemistry, hematology) by maximum toxicity (CTCAE 5.0) grades will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
Up to 60 weeks
Serum Guselkumab Concentration Over Time
Time Frame: Up to 60 weeks
Serum guselkumab concentration over time will be reported.
Up to 60 weeks
Number of Participants with Antibodies to Guselkumab
Time Frame: Up to 60 weeks
Number of participants with antibodies to guselkumab will be reported.
Up to 60 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2021

Primary Completion (Estimated)

June 6, 2025

Study Completion (Estimated)

February 13, 2026

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 11, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Estimated)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR109043
  • 2021-000465-32 (EudraCT Number)
  • CNTO1959PSA4002 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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