Sign in

NCT04936308CompletedPhase 3

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Who Had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor Alpha Agent

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
453 (actual)
First submitted
16 Jun 2021
Start date
28 Sept 2021
Primary completion date
28 Oct 2024
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04936308
EU CT number
2023-504715-33-00
EudraCT number
2021-000482-32

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 453
  • From 28 Sept 2021 to the primary completion date, 28 Oct 2024
  • 156 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has received more than 1 prior anti-tumor necrosis factor (TNF) alpha agent (or biosimilars)
  • Has ever received 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

Other illness

  • Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease
  • Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
  • Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (example, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Who the study is looking for

  • Have a diagnosis of active psoriatic arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
  • Have active PsA as defined by: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
  • Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
  • Have active plaque psoriasis, with at least one psoriatic plaque of \>= 2 centimeters (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
  • Have an inadequate response and/or intolerance to anti-tumor necrosis factor alpha (TNF alpha) therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNF alpha agent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (156)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
OMI
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Centro Privado de Medicina Familiar
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Cosultorios Reumatologógicos Pampa
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
CIPREC
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Instituto de Reumatología Mendoza
Coordinator of this site? Confirm its status
MendozaArgentinaUnknown status
Centro de Investigaciones Medicas Tucuman
Coordinator of this site? Confirm its status
San Miguel de TucumánArgentinaUnknown status
Southern Clinical Research
Coordinator of this site? Confirm its status
HobartAustraliaUnknown status
Liverpool Hospital
Coordinator of this site? Confirm its status
LiverpoolAustraliaUnknown status
Skin Health Institute Inc.
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Eastern Health - Box Hill Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
Coordinator of this site? Confirm its status
PlevenBulgariaCompleted
UNIMED Medical Center EOOD
Coordinator of this site? Confirm its status
PlovdivBulgariaCompleted
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Coordinator of this site? Confirm its status
PlovdivBulgariaCompleted
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Coordinator of this site? Confirm its status
SofiaBulgariaCompleted
Амбулатория За Специализирана Извънболнична Медицинска Помощ Ревматологичен Център Света Ирина ЕООD
Coordinator of this site? Confirm its status
SofiyaBulgariaCompleted
Rheuma s.r.o.
Coordinator of this site? Confirm its status
BřeclavCzechiaCompleted
L.K.N. Arthrocentrum, s.r.o.
Coordinator of this site? Confirm its status
HlučínCzechiaCompleted
ARTHROHELP s.r.o.
Coordinator of this site? Confirm its status
PardubiceCzechiaCompleted
MUDr. Rosypalova s.r.o.
Coordinator of this site? Confirm its status
PorubaCzechiaCompleted
Revmatologicky Ustav
Coordinator of this site? Confirm its status
Prague 2CzechiaCompleted
MEDICAL PLUS s.r.o.
Coordinator of this site? Confirm its status
Uherské HradištěCzechiaCompleted
Hospital Universitario de Cruces
Coordinator of this site? Confirm its status
BarakaldoSpainCompleted
Hospital Universitario Regional de Málaga
Coordinator of this site? Confirm its status
MálagaSpainCompleted
Clínica Gaias - Santiago
Coordinator of this site? Confirm its status
Santiago de CompostelaSpainCompleted
Hospital Quironsalud Sagrado Corazon
Coordinator of this site? Confirm its status
SevillaSpainCompleted
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Coordinator of this site? Confirm its status
Budapest IIHungaryCompleted
Uno Medical Trials Kft.
Coordinator of this site? Confirm its status
Budapest XVHungaryCompleted
Bekes Varmegyei Koezponti Korhaz
Coordinator of this site? Confirm its status
GyulaHungaryCompleted
Kistarcsai Flor Ferenc Korhaz
Coordinator of this site? Confirm its status
KistarcsaHungaryCompleted
University of Szeged
Coordinator of this site? Confirm its status
SzegedHungaryCompleted
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Coordinator of this site? Confirm its status
SzekesfehervarHungaryCompleted
Vital-Medicina Kft.
Coordinator of this site? Confirm its status
VeszpremHungaryCompleted
Carmel Medical Center
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Rambam Health Care Campus
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Bnai Zion Medical Center
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Meir Medical Center
Coordinator of this site? Confirm its status
Kfar SabaIsraelUnknown status
Sheba medical center
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status
Hospital Selayang
Coordinator of this site? Confirm its status
Batu CavesMalaysiaUnknown status
Hospital Pulau Pinang
Coordinator of this site? Confirm its status
George TownMalaysiaUnknown status
Hospital Raja Permaisuri Bainun
Coordinator of this site? Confirm its status
IpohMalaysiaUnknown status
Hospital Tuanku Jaafar
Coordinator of this site? Confirm its status
SerembanMalaysiaUnknown status
Malopolskie Badania Kliniczne Sp. z o.o.
Coordinator of this site? Confirm its status
CracowPolandCompleted
Malopolskie Centrum Kliniczne
Coordinator of this site? Confirm its status
CracowPolandCompleted
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Coordinator of this site? Confirm its status
ElblagPolandCompleted
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Coordinator of this site? Confirm its status
LodzPolandCompleted
DERMED Centrum Medyczne Sp. z o.o.
Coordinator of this site? Confirm its status
LodzPolandCompleted
NZOZ Lecznica MAK MED S C
Coordinator of this site? Confirm its status
NadarzynPolandCompleted
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Coordinator of this site? Confirm its status
Nowa SolPolandCompleted
Ai Centrum Medyczne Sp. z o.o. S.K.
Coordinator of this site? Confirm its status
PoznanPolandCompleted
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Coordinator of this site? Confirm its status
PoznanPolandCompleted
Klinika Reuma Park Sp. z o.o. S.K.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Rheuma Medicus Sp z o o
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
GCM Medical Group
Coordinator of this site? Confirm its status
San JuanPuerto RicoUnknown status
Mindful Medical Research
Coordinator of this site? Confirm its status
San JuanPuerto RicoUnknown status
FDI Clinical Research
Coordinator of this site? Confirm its status
San JuanPuerto RicoUnknown status
Altay Medical State University
Coordinator of this site? Confirm its status
BarnaulRussiaUnknown status
Chelyabinck Regional Clinical Hospital
Coordinator of this site? Confirm its status
ChelyabinskRussiaUnknown status
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Coordinator of this site? Confirm its status
ChelyabinskRussiaUnknown status
Kemerovo State Medical University
Coordinator of this site? Confirm its status
KemerovoRussiaUnknown status
LLL Medical Center Revma-Med
Coordinator of this site? Confirm its status
KemerovoRussiaUnknown status
LLC Family Outpatient Clinic # 4
Coordinator of this site? Confirm its status
KorolyovRussiaUnknown status
Krasnodar Clinical Dermatovenerologic Dispensary
Coordinator of this site? Confirm its status
KrasnodarRussiaUnknown status
Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
Coordinator of this site? Confirm its status
KrasnoyarskRussiaUnknown status
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
Clinical-Diagnostic Center Euromedservice, JSC
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
FGBU Research Institute of Rheumatology named V.A.Nasonova
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
GBOU VPO Orenburg State Medical University
Coordinator of this site? Confirm its status
OrenburgRussiaUnknown status
Rostov Regional Clinical Dermatovenerological Dispensary
Coordinator of this site? Confirm its status
Rostov-on-DonRussiaUnknown status
X7 Clinical Research Company Limited
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
St. Petersburg GBUZ Clinical Reumatological Hospital 25
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Saratov regional clinical hospital
Coordinator of this site? Confirm its status
SaratovRussiaUnknown status
Smolensk regional hospital on Smolensk railway station
Coordinator of this site? Confirm its status
SmolenskRussiaUnknown status
GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
Coordinator of this site? Confirm its status
TolyattiRussiaUnknown status
Tula Regional Clinical Dermatovenerological Dispensary
Coordinator of this site? Confirm its status
TulaRussiaUnknown status
Republican Clinical Hospital - G.G. Kuvatov
Coordinator of this site? Confirm its status
UfaRussiaUnknown status
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Coordinator of this site? Confirm its status
CherkasyUkraineUnknown status
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
Coordinator of this site? Confirm its status
KharkivUkraineUnknown status
Khmelnitckiy regional hospital
Coordinator of this site? Confirm its status
KhmelnytskyUkraineUnknown status
City Clinical Hospital No. 2
Coordinator of this site? Confirm its status
Kryvyi RihUkraineUnknown status
Kyiv City Clinical Hospital #3
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
Medical Center LLC 'Harmony of Beauty'
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
Medical Center 'Consylium Medical'
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
Medical Center of 'Institute of Rheumatology', LLC
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
Volyn Regional Clinical Hospital
Coordinator of this site? Confirm its status
LutskUkraineUnknown status
LLC Medical House
Coordinator of this site? Confirm its status
OdesaUkraineUnknown status
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
Coordinator of this site? Confirm its status
PoltavaUkraineUnknown status
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
Coordinator of this site? Confirm its status
VinnytsiaUkraineUnknown status
Medical Center LLC 'Modern Clinic'
Coordinator of this site? Confirm its status
ZaporizhzhyaUkraineUnknown status
Albuquerque Center for Rheumatology
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
Arizona Arthritis and Rheumatology Research PLLC 2
Coordinator of this site? Confirm its status
AvondaleUnited StatesUnknown status
Johns Hopkins University
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Bay Pines VA Healthcare System
Coordinator of this site? Confirm its status
Bay PinesUnited StatesUnknown status
Rheumatology and Pulmonary Clinic
Coordinator of this site? Confirm its status
BeckleyUnited StatesUnknown status
DJL Clinical Research, PLLC
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
Great Lakes Clinical Trials
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Clinical Research of West Florida
Coordinator of this site? Confirm its status
ClearwaterUnited StatesUnknown status
Precision Comprehensive Clinical Research Solutions
Coordinator of this site? Confirm its status
ColleyvilleUnited StatesUnknown status
Adriana Pop-Moody MD Clinic PA
Coordinator of this site? Confirm its status
Corpus ChristiUnited StatesUnknown status
Metroplex Clinical Research Center
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Clinical Research Center of Connecticut
Coordinator of this site? Confirm its status
DanburyUnited StatesUnknown status
Omega Research Consultants
Coordinator of this site? Confirm its status
DeBaryUnited StatesUnknown status
St. Paul Rheumatology P A
Coordinator of this site? Confirm its status
EaganUnited StatesUnknown status
Arizona Arthritis and Rheumatology Research PLLC 3
Coordinator of this site? Confirm its status
FlagstaffUnited StatesUnknown status
Precision Comprehensive Clinical Research Solutions 1
Coordinator of this site? Confirm its status
Fort WorthUnited StatesUnknown status
Klein and Associates, M.D., P.A.
Coordinator of this site? Confirm its status
HagerstownUnited StatesUnknown status
Newport Huntington Medical Group
Coordinator of this site? Confirm its status
Huntington BeachUnited StatesUnknown status
Great Lakes Center of Rheumatology
Coordinator of this site? Confirm its status
LansingUnited StatesUnknown status
Arthritis and Osteoperosis Associates of New Mexico
Coordinator of this site? Confirm its status
Las CrucesUnited StatesUnknown status
West Texas Clinical Research
Coordinator of this site? Confirm its status
LubbockUnited StatesUnknown status
Dr. Ramesh Gupta
Coordinator of this site? Confirm its status
MemphisUnited StatesUnknown status
Arizona Arthritis and Rheumatology Research PLLC
Coordinator of this site? Confirm its status
MesaUnited StatesUnknown status
SouthWest Rheumatology Research, LLC
Coordinator of this site? Confirm its status
MesquiteUnited StatesUnknown status
The Arthritis and Diabetes Clinic
Coordinator of this site? Confirm its status
MonroeUnited StatesUnknown status
Arthritis Associates
Coordinator of this site? Confirm its status
Mountain BrookUnited StatesUnknown status
Advanced Clinical Research of Orlando
Coordinator of this site? Confirm its status
OcoeeUnited StatesUnknown status
Arthritis and Rheumatology Center of MI
Coordinator of this site? Confirm its status
OkemosUnited StatesUnknown status
Rheumatology Associates of Oklahoma
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
Health Research of Oklahoma
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
Buffalo Rheumatology and Medicine, PLLC
Coordinator of this site? Confirm its status
Orchard ParkUnited StatesUnknown status
Arizona Arthritis and Rheumatology Research PLLC 1
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Texas Rheumatology Care
Coordinator of this site? Confirm its status
PlanoUnited StatesUnknown status
Integral Rheumatology And Immunology Specialists
Coordinator of this site? Confirm its status
PlantationUnited StatesUnknown status
Clinical Research Institute of Michigan, LLC
Coordinator of this site? Confirm its status
Saint Clair ShoresUnited StatesUnknown status
Unity Health-White County Medical Center
Coordinator of this site? Confirm its status
SearcyUnited StatesUnknown status
Clinic of Robert Hozman
Coordinator of this site? Confirm its status
SkokieUnited StatesUnknown status
Arthritis Northwest PLLC 1
Coordinator of this site? Confirm its status
SpokaneUnited StatesUnknown status
Arthritis Consultants
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Arizona Arthritis and Rheumatology Associates
Coordinator of this site? Confirm its status
Sun CityUnited StatesUnknown status
Clinical Research of West Florida 1
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Advanced Rheumatology of Houston
Coordinator of this site? Confirm its status
The WoodlandsUnited StatesUnknown status
Medvin Clinical Research 2
Coordinator of this site? Confirm its status
Thousand OaksUnited StatesUnknown status
DM Clinical Research
Coordinator of this site? Confirm its status
TomballUnited StatesUnknown status
Southern Arizona VA Healthcare System
Coordinator of this site? Confirm its status
TucsonUnited StatesUnknown status
Medvin Clinical Research
Coordinator of this site? Confirm its status
TujungaUnited StatesUnknown status
STAT Research, Inc.
Coordinator of this site? Confirm its status
VandaliaUnited StatesUnknown status
Arthritis Rheumatic And Back Disease Associates
Coordinator of this site? Confirm its status
Voorhees TownshipUnited StatesUnknown status
Arthritis And Osteoporosis Clinic
Coordinator of this site? Confirm its status
WacoUnited StatesUnknown status
Florida Medical Clinic, P.A.
Coordinator of this site? Confirm its status
ZephyrhillsUnited StatesUnknown status
Adana City Hospital
Coordinator of this site? Confirm its status
AdanaTurkey (Türkiye)Unknown status
Gulhane Egitim ve Arastirma Hastanesi
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent City Hospital
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Hacettepe University Medical Faculty
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Akdeniz Universitesi Hastanesi
Coordinator of this site? Confirm its status
AntalyaTurkey (Türkiye)Unknown status
Bursa Uludag Universitesi Hastanesi
Coordinator of this site? Confirm its status
BursaTurkey (Türkiye)Unknown status
Pamukkale University Medical Faculty
Coordinator of this site? Confirm its status
DenizliTurkey (Türkiye)Unknown status
Osmangazi University Medical Faculty
Coordinator of this site? Confirm its status
EskişehirTurkey (Türkiye)Unknown status
Marmara University Medical Faculty
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status
Istanbul University Istanbul Medical Faculty
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status
Kartal Dr Lutfi Kirdar Sehir Hastanesi
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status
Istanbul University Cerrahpasa Medical Faculty
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status
Kocaeli University Medical Faculty
Coordinator of this site? Confirm its status
KocaeliTurkey (Türkiye)Unknown status
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
Coordinator of this site? Confirm its status
KonyaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.