Fact CheckerSign in

NCT05071664CompletedPhase 2

A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

A Phase 2a, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

Source: ClinicalTrials.gov · Last updated 23 Jul 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
91 (actual)
First submitted
6 Sept 2021
Start date
25 Oct 2021
Primary completion date
14 May 2024
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05071664
EudraCT number
2021-002012-31

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 91
  • From 25 Oct 2021 to the primary completion date, 14 May 2024
  • 82 sites in 10 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 prior treatment with golimumab or guselkumab or has documented intolerance to prior anti-TNF-alpha therapy in the participant history by the treating physician
  • Has received more than 2 prior anti-TNF-alpha agents (or biosimilars)

Other illness

  • Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr AxSpA), systemic lupus erythematosus, or lyme disease
  • Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies (mAb), or antibody fragments
  • Positive human immunodeficiency virus (HIV) antibody test

Who the study is looking for

  • Have a diagnosis of psoriatic arthritis (PsA) for greater than or equal to (\>=) 6 months prior to the first administration of study intervention and meet Classification criteria for PsA (CASPAR) criteria at screening
  • Have active PsA as defined by having at least 3 swollen joints and at least 3 tender joints at screening and at baseline
  • Have at least 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
  • Have active plaque psoriasis, with at least one psoriatic plaque of \>=2 centimeter (cm) diameter or nail changes consistent with psoriasis
  • Have an inadequate response (IR) to anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite treatment with either 1 or 2 prior anti-TNF-alpha agent(s) and the following: a. Lack of benefit to either 1 or 2 prior anti-TNF-alpha therapies, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, or any biosimilar of these 4 therapies. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; b. The last dose of anti-TNF-alpha therapy must have occurred greater than 5 half-lives of the drug prior to first study intervention administration (washout period)

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (82)

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

SiteCityCountrySite status
Frederiksberg Hospital
Coordinator of this site? Confirm its status
FrederiksbergDenmarkUnknown status
Rigshospitalet Glostrup
Coordinator of this site? Confirm its status
Glostrup MunicipalityDenmarkUnknown status
Køge Sygehus Region Sjaelland
Coordinator of this site? Confirm its status
KøgeDenmarkUnknown status
Silkeborg Hospital
Coordinator of this site? Confirm its status
SilkeborgDenmarkUnknown status
Vejle Sygehus
Coordinator of this site? Confirm its status
VejleDenmarkUnknown status
Hosp Univ A Coruna
Coordinator of this site? Confirm its status
A CoruñaSpainUnknown status
Hosp. Univ. Germans Trias I Pujol
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hosp. Univ. de Basurto
Coordinator of this site? Confirm its status
BilbaoSpainUnknown status
Hosp Reina Sofia
Coordinator of this site? Confirm its status
CórdobaSpainUnknown status
Hosp. Univ. 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Corporacio Sanitari Parc Tauli
Coordinator of this site? Confirm its status
SabadellSpainUnknown status
Hosp. Clinico Univ. de Santiago
Coordinator of this site? Confirm its status
Santiago de CompostelaSpainUnknown status
Hosp. Virgen Macarena
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Hosp. Infanta Luisa
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Hosp. Ntra. Sra. de Valme
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Centre Hospitalier Le Mans
Coordinator of this site? Confirm its status
Le MansFranceUnknown status
Hôpital Larrey - CHU de Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
CHU Trousseau - Service de Rhumatologie
Coordinator of this site? Confirm its status
ToursFranceUnknown status
Obudai Egeszsegugyi Centrum Kft
Coordinator of this site? Confirm its status
BudapestHungaryUnknown status
Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház
Coordinator of this site? Confirm its status
GyulaHungaryUnknown status
Complex Rendelo Med Zrt.
Coordinator of this site? Confirm its status
SzékesfehérvárHungaryUnknown status
Vital Medical Center
Coordinator of this site? Confirm its status
VeszprémHungaryUnknown status
Azienda Ospedaliero - Universitaria di Cagliari
Coordinator of this site? Confirm its status
CagliariItalyUnknown status
Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Coordinator of this site? Confirm its status
PaviaItalyUnknown status
Arcispedale Santa Maria Nuova - IRCCS
Coordinator of this site? Confirm its status
Reggio EmiliaItalyUnknown status
Policlinico Universitario Agostino Gemelli
Coordinator of this site? Confirm its status
RomaItalyUnknown status
A.O.U.Policlinico Tor Vergata
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Università Campus Biomedico di Roma
Coordinator of this site? Confirm its status
RomeItalyUnknown status
AO Ordine Mauriziano
Coordinator of this site? Confirm its status
TorinoItalyUnknown status
Centrum Kliniczno-Badawcze
Coordinator of this site? Confirm its status
ElblagPolandUnknown status
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
Coordinator of this site? Confirm its status
LódzPolandUnknown status
NZOZ Lecznica MAK MED S C
Coordinator of this site? Confirm its status
NadarzynPolandUnknown status
Centrum Medyczne
Coordinator of this site? Confirm its status
PoznanPolandUnknown status
Centrum Medyczne AMED Targowek
Coordinator of this site? Confirm its status
WarsawPolandUnknown status
Medycyna Kliniczna
Coordinator of this site? Confirm its status
WarsawPolandUnknown status
WroMedica I Bielicka A Strzalkowska s c
Coordinator of this site? Confirm its status
WroclawPolandUnknown 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
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
Orenburg State Medical Academy
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
Ryazan Regional Clinical Dermatovenerological Dispensary
Coordinator of this site? Confirm its status
RyazanRussiaUnknown status
X7 Clinical Research Company Limited
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Smolensk regional hospital on Smolensk railway station
Coordinator of this site? Confirm its status
SmolenskRussiaUnknown status
Republican Clinical Hospital - G.G. Kuvatov
Coordinator of this site? Confirm its status
UfaRussiaUnknown status
Clinical Hospital #3
Coordinator of this site? Confirm its status
YaroslavlRussiaUnknown status
Skånes universitetssjukhus
Coordinator of this site? Confirm its status
MalmöSwedenUnknown status
Karolinska Universitetssjukhuset Solna
Coordinator of this site? Confirm its status
SolnaSwedenUnknown status
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Coordinator of this site? Confirm its status
KharkivUkraineUnknown status
State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
Coordinator of this site? Confirm its status
KharkivUkraineUnknown status
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
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
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
Coordinator of this site? Confirm its status
PoltavaUkraineUnknown status
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Coordinator of this site? Confirm its status
TernopilUkraineUnknown status
MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
Coordinator of this site? Confirm its status
UzhhorodUkraineUnknown status
Health Clinic Limited Liability Company
Coordinator of this site? Confirm its status
VinnytsiaUkraineUnknown status
Medical Center LLC 'Modern Clinic'
Coordinator of this site? Confirm its status
ZaporizhzhyaUkraineUnknown status
HARAC Research Corp
Coordinator of this site? Confirm its status
Avon ParkUnited StatesUnknown status
Bay Pines VA Healthcare System
Coordinator of this site? Confirm its status
Bay PinesUnited StatesUnknown status
NYU Langone Ambulatory Care Brooklyn Heights
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status
Omega Research Consultants
Coordinator of this site? Confirm its status
DeBaryUnited StatesUnknown status
Great Lakes Center of Rheumatology
Coordinator of this site? Confirm its status
LansingUnited StatesUnknown status
Atlanta Research Center for Rheumatology
Coordinator of this site? Confirm its status
MariettaUnited StatesUnknown status
South Coast Research Center
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
NYU School of Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Advanced Clinical Research of Orlando
Coordinator of this site? Confirm its status
OcoeeUnited StatesUnknown status
Millennium Research
Coordinator of this site? Confirm its status
Ormond BeachUnited StatesUnknown status
Arizona Arthritis and Rheumatology Research PLLC 1
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Arizona Arthritis and Rheumatology Research PLLC
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Trinity Universal Research Associates, LLC
Coordinator of this site? Confirm its status
PlanoUnited StatesUnknown status
University of Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Unity Health-White County Medical Center
Coordinator of this site? Confirm its status
SearcyUnited StatesUnknown status
Swedish Medical Center
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Clinvest
Coordinator of this site? Confirm its status
SpringfieldUnited StatesUnknown status
Jacobi Medical Center
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status
DM Clinical Research
Coordinator of this site? Confirm its status
TomballUnited StatesUnknown status
STAT Research, Inc.
Coordinator of this site? Confirm its status
VandaliaUnited StatesUnknown status

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