AzTrials
AzTrials

Arthritis, PsoriaticPhase 4STARNCT04929210

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

A Phase 4 study testing Guselkumab in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 240 sites in 26 countries.

Active, not recruiting

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

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
411 participants
Where
240 sitesin 26 countries
Study dates
30 Aug 2021to 13 Apr 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

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

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

Who may be able to join

  • Have 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

Who cannot join

  • 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

Trial locations and contacts

240 sites in 26 countries.

240 sites in 26 countries

United States38 sites

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

  • Austin Regional Clinic

    Austin, Texas, 78731

  • Arizona Arthritis and Rheumatology Research PLLC 1

    Avondale, Arizona, 85392

  • Johns Hopkins Bayview Medical

    Baltimore, Maryland, 21224

  • Bay Pines VA Healthcare System

    Bay Pines, Florida, 33744

  • Arizona Arthritis & Rheumatology Research, PLLC

    Chandler, Arizona, 85225

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034

  • Adriana Pop Moody MD Clinic PA

    Corpus Christi, Texas, 78404

  • Clinical Research Center of Connecticut

    Danbury, Connecticut, 06810

  • St. Paul Rheumatology P A

    Eagan, Minnesota, 55121

  • Kaiser Permanent Medical Center

    Fontana, California, 92335

  • AARA Clinical Research Lone Star Arthritis and Rheumatology 1

    Fort Worth, Texas, 76109

  • Klein And Associates M D P A

    Hagerstown, Maryland, 21740

  • UT Physicians Center for Autoimmunity

    Houston, Texas, 77030

  • Newport Huntington Medical Group

    Huntington Beach, California, 92648

  • AARA Clinical Research Lone Star Arthritis and Rheumatology

    Irving, Texas, 75039

  • Kansas City Physician Partners

    Kansas City, Missouri, 64111

  • University Of California San Diego

    La Jolla, California, 92093

  • West Texas Clinical Research

    Lubbock, Texas, 79424

  • Arizona Arthritis and Rheumatology Research PLLC

    Mesa, Arizona, 85210

  • Southwest Rheumatology Research LLC

    Mesquite, Texas, 75150

  • Arizona Arthritis Research, PLC.

    Phoenix, Arizona, 85032

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida, 33324

  • OHSU Rheumatology Clinic, Marquam Hill

    Portland, Oregon, 97239

  • Epic Medical Research

    Red Oak, Texas, 75154

  • OrthoIllinois

    Rockford, Illinois, 61114

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan, 48081

  • Rheumatology Center of San Diego

    San Diego, California, 92128

  • Unity Health-White County Medical Center

    Searcy, Arkansas, 72143

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Clinvest

    Springfield, Missouri, 65807

  • Arizona Arthritis and Rheumatology Associates

    Sun City, Arizona, 85351

  • DM Clinical Research

    Tomball, Texas, 77375

  • Southern Arizona VA Healthcare System

    Tucson, Arizona, 85723

  • STAT Research, Inc.

    Vandalia, Ohio, 45377

  • Willow Rheumatology and Wellness

    Willowbrook, Illinois, 60527

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

Poland26 sites

  • ClinicMed Daniluk Nowak Spolka Komandytowa

    Bialystok, 15 879

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela

    Bydgoszcz, 85 168

  • Nzoz Bif Med

    Bytom, 41 902

  • Ambulatorium sp. z o.o.

    Elblag, 82-300

  • Centrum Kliniczno Badawcze

    Elblag, 82-300

  • Malopolskie Badania Kliniczne Sp z o o

    Krakow, 30-002

  • Centrum Medyczne Promed

    Krakow, 31-513

  • Dermed Centrum Medyczne Sp z o o

    Lodz, 90-265

  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz, 90-338

  • Centrum Medyczne AMED oddzial w Lodzi

    Lodz, 91 363

  • Reumed Zespol Poradni Specjalistycznych Filia nr 1

    Lublin, 20 607

  • Velocity Lublin

    Lublin, 20 831

  • Pro Life Medica Sp. z o.o.

    Lublin, 20-412

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05-830

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100

  • Twoja Przychodnia PCM

    Poznan, 60 324

  • Reumedika s c Wieslawa Porawska Lukasz Porawski

    Poznan, 60-446

  • Lubelskie Centrum Diagnostyczne

    Świdnik, 21 040

  • MICS Centrum Medyczne Torun

    Torun, 87-100

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

  • Rheuma Medicus Sp z o o

    Warsaw, 02 118

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

    Warsaw, 02 637

  • Centrum Medyczne Reuma Park

    Warsaw, 02-665

  • ETG Warszawa

    Warsaw, 02-793

  • Centrum Medyczne AMED Targowek

    Warsaw, 03 291

  • WroMedica I Bielicka A Strzalkowska s c

    Wroclaw, 51 685

Other trials in Poland

Russia21 sites

  • Altay Medical State University

    Barnaul, 656038

  • Chelyabinck Regional Clinical Hospital

    Chelyabinsk, 454076

  • Chelyabinsk Regional Clinical Dermatovenerological Dispensary

    Chelyabinsk, 454092

  • Regional Clinical Diagnostic Center of Udmurtia Region

    Izhevsk, 426009

  • LLL Medical Center Revma-Med

    Kemerovo, 650070

  • LLC Family Outpatient Clinic # 4

    Korolyov, 141060

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

    Krasnoyarsk, 660123

  • Clinical-Diagnostic Center Euromedservice, JSC

    Moscow, 115419

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

    Moscow, 115522

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

    Moscow, 129110

  • Llc Ultramed

    Omsk, 644024

  • GBOU VPO Orenburg State Medical University

    Orenburg, 460000

  • GBUZ Perm Regional Clinical Hospital

    Perm, 614990

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

    Petrozavodsk, 185019

  • Rostov Regional Clinical Dermatovenerological Dispensary

    Rostov-on-Don, 344007

  • St. Petersburg GBUZ Clinical Reumatological Hospital 25

    Saint Petersburg, 190068

  • X7 Clinical Research Company Limited

    Saint Petersburg, 194156

  • GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'

    Tolyatti, 445846

  • Republican Clinical Hospital - G.G. Kuvatov

    Ufa, 450005

  • Clinical Hospital #3

    Yaroslavl, 150007

  • Sverdlovsk Regional Clinical Hospital N. 1

    Yekaterinburg, 620102

Other trials in Russia

Georgia15 sites

  • Ltd Health Center

    Batumi, 6010

  • LTD Clinic LJ

    Kutaisi, 4600

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi, 0102

  • Ltd American Hospital Network

    Tbilisi, 0102

  • LTD Helsicore

    Tbilisi, 0112

  • Ltd New Hospitals

    Tbilisi, 0114

  • TSMU The First University Clinic

    Tbilisi, 0141

  • JSC K Eristavi National Center of experimental and Clinical surgery

    Tbilisi, 0159

  • Tbilisi Heart and Vascular Clinic Ltd

    Tbilisi, 0159

  • LTD 'Aversi Clinic'

    Tbilisi, 0160

  • LTD MediClub Georgia

    Tbilisi, 0160

  • Clinic on Mtskheta Street

    Tbilisi, 0179

  • LTD The First Medical Center

    Tbilisi, 0180

  • Consilium Medulla-multiprofile clinic Ltd

    Tbilisi, 0186

  • JSC Evex Hospitals

    Tnilisi, 0159

Other trials in Georgia

Bulgaria13 sites

  • Exacta Medica

    Pleven, 5803

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5804

  • Medical Center Unimed Plovdiv

    Plovdiv, 4001

  • UMHAT Kaspela

    Plovdiv, 4001

  • Medical Center Artmed

    Plovdiv, 4002

  • MHAT 'Lyulin' EAD

    Sofia, 1336

  • University Multiprofile Hospital Sofiamed Sofia

    Sofia, 1336

  • Military Medical Academy

    Sofia, 1606

  • UMHAT St. Ivan Rilski

    Sofia, 1612

  • DCC Convex EOOD

    Sofia, 1680

  • ASIMP Rheumatology Centre St Irina EOOD

    Sofia, 1750

  • Medical Centre Synexus

    Sofia, 1794

  • DDC Sv. Ivan Rilski OOD

    Targovishte, 7700

Other trials in Bulgaria

Ukraine13 sites

  • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009

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

    Kharkiv, 61204

  • Khmelnitckiy regional hospital

    Khmelnytsky, 29000

  • City Clinical Hospital No. 2

    Kryvyi Rih, 50056

  • Medical Center of 'Institute of Rheumatology', LLC

    Kyiv, 02081

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

    Kyiv, 03049

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

    Kyiv, 03680

  • Volyn Regional Clinical Hospital

    Lutsk, 43005

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

    Odesa, 65025

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

    Poltava, 36011

  • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

    Ternopil, 46002

  • Health Clinic Limited Liability Company

    Vinnytsia, 21009

  • Medical Center LLC 'Modern Clinic'

    Zaporizhzhya, 69600

Other trials in Ukraine

Spain12 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp. Univ. de Cruces

    Barakaldo, 48902

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Univ. de Basurto

    Bilbao, 48013

  • Hosp Reina Sofia

    Córdoba, 14004

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hosp Regional Univ de Malaga

    Málaga, 29009

  • Corporacio Sanitari Parc Tauli

    Sabadell, 8208

  • Clinica Gaias

    Santiago de Compostela, 15702

  • Hosp. Virgen Macarena

    Seville, 41009

  • Hosp. Quiron Sagrado Corazon

    Seville, 41013

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

Other trials in Spain

Czechia9 sites

  • Revmaclinic

    Brno, 61141

  • Revmatologie s r o

    Brno, 63800

  • Revmacentrum MUDr Mostera s r o

    Brno-Židenice, 615 00

  • L K N Arthrocentrum

    Hlučín, 748 01

  • Revimex Pro s r o

    Karvina Frystat, 73301

  • MUDr Rosypalova s r o

    Ostrava, 70800

  • Arthrohelp S.R.O.

    Pardubice, 53002

  • Revmatologicky ustav

    Prague, 128 00

  • Medical Plus S R O

    Uherské Hradiště, 68601

Other trials in Czechia

Turkey (Türkiye)9 sites

  • Adana City Hospital

    Adana, 01370

  • Gulhane Training and Research Hospital

    Ankara, 06010

  • Ankara Bilkent City Hospital

    Ankara, 06800

  • Hacettepe University Medical Faculty

    Ankara, 6100

  • Akdeniz University Medical Faculty

    Antalya, 7059

  • Uludag University Medical Faculty

    Bursa, 16059

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Marmara University Medical Faculty

    Istanbul, 34899

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080

Other trials in Turkey (Türkiye)

Hungary8 sites

  • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

    Budapest, 1023

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Qualiclinic Kft

    Budapest, H-1036

  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700

  • Porcika Klinika - Vasarhelyi Sarkanyfu Kft.

    Hódmezővásárhely, 6800

  • Kistarcsai Flor Ferenc Korhaz

    Kistarcsa, 2143

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

    Székesfehérvár, 8000

  • Vital Medical Center Orvosi es Fogaszati Kozpont

    Veszprém, 8200

Other trials in Hungary

Portugal8 sites

  • Uls Braga - Hosp. Braga

    Braga, 4710-243

  • Ulsg - Hosp. Sousa Martins

    Guarda, 6300-749

  • Ipr Inst Port de Reumatologia

    Lisbon, 1050 034

  • Uls Lisboa Ocidental - Hosp. Egas Moniz

    Lisbon, 1349-019

  • Hosp. Cuf Tejo

    Lisbon, 1350-352

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649-035

  • Ulsam - Hosp. Conde de Bertiandos

    Ponte de Lima, 4990-041

  • Uls Sao Joao - Hosp. Sao Joao

    Porto, 4200 319

Other trials in Portugal

Philippines7 sites

  • Cebu Doctors' University Hospital

    Cebu City, 6000

  • Davao Doctors Hospital

    Davao City, 8000

  • Lipa Medix Medical Hospital

    Lipa, 4217

  • ManilaMed Medical Center Manila

    Manila, 1000

  • Philippine General Hospital

    Manila, 1000

  • St. Luke's Medical Center

    Quezon City, 1112

  • Ilocos Training and Regional Medical Center

    San Fernando City, 2500

Other trials in Philippines

United Kingdom7 sites

  • Royal Free London NHS Foundation Trust

    Barnet, EN5 3DJ

  • St. Lukes Hospital

    Bradford, BD5 0NA

  • University Hospital Coventry & Warwickshire NHS Trust

    Coventry, CV2 2DX

  • Chapel Allerton Hospital

    Leeds, LS7 4SA

  • Central Manchester University Hospitals NHS Foundation Trust

    Manchester, M13 9WL

  • North Tyneside General Hospital

    Newcastle, NE29 8NH

  • Haywood Hospital

    Stoke-on-Trent, ST6 7AG

Other trials in United Kingdom

Argentina6 sites

  • Cosultorios Reumatologógicos Pampa

    Buenos Aires, 1428

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

  • Centro Privado de Medicina Familiar

    Buenos Aires, C1417

  • Hospital Italiano La Plata

    La Plata, B1900

  • MR Medicina Reumatologica

    San Fernando, B1646

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Australia6 sites

  • Emeritus Research

    Camberwell, 3124

  • Southern Clinical Research

    Hobart, 7000

  • Liverpool Hospital

    Liverpool, 2170

  • Rheumatology Research Unit

    Maroochydore, 4558

  • Skin Health Institute Inc.

    Melbourne, 3053

  • Eastern Health - Box Hill Hospital

    Melbourne, 3128

Other trials in Australia

Italy6 sites

  • A.O. Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126

  • Azienda Ospedaliero-Universitaria di Cagliari

    Monserrato, 09124

  • Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, 42123

  • Policlinico Tor Vergata

    Roma, 00133

  • Humanitas Hospital

    Rozzano (MI), 20089

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126

Other trials in Italy

Israel5 sites

  • Bnai Zion Medical Center

    Haifa, 31048

  • Carmel Medical Center

    Haifa, 34362

  • Wolfson Medical Center

    Holon, 5822012

  • Meir Medical Center

    Kfar Saba, 4428164

  • Sheba Medical Center

    Ramat Gan, 5265601

Other trials in Israel

Malaysia5 sites

  • Hospital Selayang

    Batu Caves, 68100

  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Sultan Ismail

    Johor Bahru, 81100

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tuanku Jaafar

    Seremban, 70300

Other trials in Malaysia

Slovakia5 sites

  • Reumatologicka Ambulancia 1

    Martin, 036 01

  • Reumatologicka ambulancia

    Nové Mesto nad Váhom, 91501

  • Reumatologická ambulancia Thermium s.r.o.

    Piešťany, 921 01

  • REUMAMED POPRAD, s.r.o.

    Poprad, 05801

  • Reumex s.r.o

    Rimavská Sobota

Other trials in Slovakia

Canada4 sites

  • G R M O Groupe de recherche en maladies osseuses Inc

    Québec, Quebec, G1V 3M7

  • Eastern Regional Health Authority St Clares Mercy Hospital

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

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Skin Care Centre

    Vancouver, British Columbia, V5Z 4E8

Other trials in Canada

Denmark4 sites

  • Frederiksberg Hospital

    Frederiksberg, 2000

  • Rigshospitalet Glostrup

    Glostrup Municipality, 2600

  • Køge Sygehus Region Sjaelland

    Køge, 4600

  • Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

Germany4 sites

  • ISA - Interdisciplinary Study Association GmbH

    Berlin, 10789

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Rheumazentrum Ratingen

    Ratingen, 40878

Other trials in Germany

Taiwan3 sites

  • National Taiwan University Hospital

    Hsinchu, 30059

  • National Cheng Kung University Hospital

    Tainan, 704

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

Thailand3 sites

  • Phramongkutklao Hospital and Medical College

    Bangkok, 10400

  • Ramathibodi Hospital Mahidol University

    Bangkok, 10400

  • Chiang Mai University

    Chiang Mai, 50200

Other trials in Thailand

Sweden2 sites

  • Karolinska Universitetssjukhuset

    Solna, 171 76

  • Akademiska Sjukhuset

    Uppsala, 753 09

Other trials in Sweden

Hong Kong1 site

  • Prince Of Wales Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Being tested
Guselkumab, Placebo
Medical subject headings
Arthritis, Psoriatic

What participants receive

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

  • GuselkumabDrug

    Also called TREMFYA

    Guselkumab will be administered as subcutaneous injection.

  • PlaceboDrug

    Matching placebo will be administered as subcutaneous injection.

Study groups in NCT04929210
Study groupRoleWhat they receive
Group 1: Guselkumab and PlaceboExperimentalParticipants will receive guselkumab and matching placebo subcutaneously (SC) to maintain the blind.
Receives: Drug: Guselkumab; Drug: Placebo
Group 2: GuselkumabExperimentalParticipants will receive guselkumab SC.
Receives: Drug: Guselkumab
Group 3: Placebo followed by GuselkumabExperimentalParticipants will receive matching placebo and will cross over to receive guselkumab SC.
Receives: Drug: Guselkumab; Drug: Placebo

What is being measured

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

  1. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at 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.

    Measured: Baseline and Week 24

Secondary outcomes (19)

  1. Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at 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.

    Measured: Baseline and Week 24

  2. Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at 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.

    Measured: Baseline and Week 24

  3. Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at 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.

    Measured: Baseline and Week 24

  4. 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

    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).

    Measured: Week 24

  5. Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints at 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.

    Measured: Baseline and Week 24

  6. Percentage of Participants who Achieve a >= 50 % Improvement from Baseline in BASDAI Score at Week 24

    Percentage of participants who achieve a >= 50 % improvement from baseline in BASDAI score at week 24 will be reported.

    Measured: Baseline and Week 24

  7. Percentage of Participants who Achieve ASDAS Clinically Important Improvement at Week 24

    Percentage of participants who achieve ASDAS clinically important improvement at week 24 will be reported.

    Measured: Week 24

  8. Percentage of Participants who Achieve Ankylosing Spondylitis Activity Score (ASAS) 40 Response at 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.

    Measured: Week 24

  9. Percentage of Participants who Achieve ASDAS Major Improvement at Week 24

    Percentage of participants who achieve ASDAS major improvement at Week 24 will be reported.

    Measured: Week 24

  10. Change from Baseline in SPARCC Score for MRI Spine at 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.

    Measured: Baseline and Week 24

  11. Number of Participants with Adverse Events (AEs)

    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.

    Measured: Up to 60 weeks

  12. Number of Participants with Serious Adverse Events (SAEs)

    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.

    Measured: Up to 60 weeks

  13. Number of Participants with Reasonably Related AEs

    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.

    Measured: Up to 60 weeks

  14. Number of Participants with AEs Leading to Discontinuation of Study Intervention

    Number of participants with AEs leading to discontinuation of study intervention will be reported.

    Measured: Up to 60 weeks

  15. Number of Participants with Infections

    Number of participants with infections will be reported.

    Measured: Up to 60 weeks

  16. Number of participants with Injection-Site Reactions

    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.

    Measured: Up to 60 weeks

  17. Number of Participants with Laboratory Abnormalities (Chemistry, Hematology) by Maximum Toxicity (Common Terminology Criteria for Adverse Events [CTCAE 5.0]) Grades

    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.

    Measured: Up to 60 weeks

  18. Serum Guselkumab Concentration Over Time

    Serum guselkumab concentration over time will be reported.

    Measured: Up to 60 weeks

  19. Number of Participants with Antibodies to Guselkumab

    Number of participants with antibodies to guselkumab will be reported.

    Measured: Up to 60 weeks

Timeline

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

  1. First posted18 Jun 2021
  2. Study start30 Aug 2021
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion13 Apr 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
411 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04929210
Sponsor's protocol ID
CR109043
Other IDs
CNTO1959PSA4002, 2021-000465-32, 2023-504716-15-00, 2023
Acronym
STAR
Status last verified
Nov 2026
First submitted
11 Jun 2021
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/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

Publications

  • Baraliakos X, Bird P, Deodhar A, Gladman DD, Helliwell PS, Poddubnyy D, Kavanaugh A, Ostergaard M, Soriano ER, Tam LS, Chakravarty SD, Leibowitz E, Gong C, Adelakun O, Xu S, Fuerst T, Saeed N, Landewe R, Mease PJ. Associations Between Clinical Characteristics and Magnetic Resonance Imaging of the Sacroiliac Joints and Spine: Exploratory Analysis of the Phase 4, Randomized, Placebo-Controlled STAR Study. J Psoriasis Psoriatic Arthritis. 2026 Oct 18:24755303261494534. doi: 10.1177/24755303261494534. Online ahead of print.

    PubMed 42898665

  • Kharouf F, Gladman DD. Advances in the management of psoriatic arthritis in adults. BMJ. 2024 Nov 21;387:e081860. doi: 10.1136/bmj-2024-081860.

    PubMed 39572047

  • 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.

    PubMed 36064592

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Guselkumab in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 240 sites in 26 countries.

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

Who may be eligible to take part?

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

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 240 sites in United States, Poland, Russia, Georgia, Bulgaria and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

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

What does the primary outcome measure?

Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04929210, which also lists 3 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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