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
- Diseases
- Psoriasis, Psoriatic arthritis
- 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
Sites (82)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Frederiksberg Hospital Coordinator of this site? Confirm its status | Frederiksberg | Denmark | Unknown status |
| Rigshospitalet Glostrup Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
| Køge Sygehus Region Sjaelland Coordinator of this site? Confirm its status | Køge | Denmark | Unknown status |
| Silkeborg Hospital Coordinator of this site? Confirm its status | Silkeborg | Denmark | Unknown status |
| Vejle Sygehus Coordinator of this site? Confirm its status | Vejle | Denmark | Unknown status |
| Hosp Univ A Coruna Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hosp. Univ. Germans Trias I Pujol Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. de Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Unknown status |
| Hosp Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hosp. Univ. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Corporacio Sanitari Parc Tauli Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
| Hosp. Clinico Univ. de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hosp. Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hosp. Infanta Luisa Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hosp. Ntra. Sra. de Valme Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| Hôpital Larrey - CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CHU Trousseau - Service de Rhumatologie Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Obudai Egeszsegugyi Centrum Kft Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház Coordinator of this site? Confirm its status | Gyula | Hungary | Unknown status |
| Complex Rendelo Med Zrt. Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Unknown status |
| Vital Medical Center Coordinator of this site? Confirm its status | Veszprém | Hungary | Unknown status |
| Azienda Ospedaliero - Universitaria di Cagliari Coordinator of this site? Confirm its status | Cagliari | Italy | Unknown status |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Arcispedale Santa Maria Nuova - IRCCS Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| Policlinico Universitario Agostino Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| A.O.U.Policlinico Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Università Campus Biomedico di Roma Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| AO Ordine Mauriziano Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Centrum Kliniczno-Badawcze Coordinator of this site? Confirm its status | Elblag | Poland | Unknown status |
| Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna Coordinator of this site? Confirm its status | Lódz | Poland | Unknown status |
| NZOZ Lecznica MAK MED S C Coordinator of this site? Confirm its status | Nadarzyn | Poland | Unknown status |
| Centrum Medyczne Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Centrum Medyczne AMED Targowek Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Medycyna Kliniczna Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| WroMedica I Bielicka A Strzalkowska s c Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Kemerovo State Medical University Coordinator of this site? Confirm its status | Kemerovo | Russia | Unknown status |
| LLL Medical Center Revma-Med Coordinator of this site? Confirm its status | Kemerovo | Russia | Unknown status |
| LLC Family Outpatient Clinic # 4 Coordinator of this site? Confirm its status | Korolyov | Russia | Unknown status |
| GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi' Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Orenburg State Medical Academy Coordinator of this site? Confirm its status | Orenburg | Russia | Unknown status |
| Rostov Regional Clinical Dermatovenerological Dispensary Coordinator of this site? Confirm its status | Rostov-on-Don | Russia | Unknown status |
| Ryazan Regional Clinical Dermatovenerological Dispensary Coordinator of this site? Confirm its status | Ryazan | Russia | Unknown status |
| X7 Clinical Research Company Limited Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Smolensk regional hospital on Smolensk railway station Coordinator of this site? Confirm its status | Smolensk | Russia | Unknown status |
| Republican Clinical Hospital - G.G. Kuvatov Coordinator of this site? Confirm its status | Ufa | Russia | Unknown status |
| Clinical Hospital #3 Coordinator of this site? Confirm its status | Yaroslavl | Russia | Unknown status |
| Skånes universitetssjukhus Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| Karolinska Universitetssjukhuset Solna Coordinator of this site? Confirm its status | Solna | Sweden | Unknown status |
| Municipal Institution Regional hospital-center of emergency care and disasters medicine Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| State Institution Institute of therapy named after L.T.Malaya AMS Ukraine Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway' Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil Coordinator of this site? Confirm its status | Poltava | Ukraine | Unknown status |
| Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital' Coordinator of this site? Confirm its status | Ternopil | Ukraine | Unknown status |
| MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council Coordinator of this site? Confirm its status | Uzhhorod | Ukraine | Unknown status |
| Health Clinic Limited Liability Company Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| Medical Center LLC 'Modern Clinic' Coordinator of this site? Confirm its status | Zaporizhzhya | Ukraine | Unknown status |
| HARAC Research Corp Coordinator of this site? Confirm its status | Avon Park | United States | Unknown status |
| Bay Pines VA Healthcare System Coordinator of this site? Confirm its status | Bay Pines | United States | Unknown status |
| NYU Langone Ambulatory Care Brooklyn Heights Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Omega Research Consultants Coordinator of this site? Confirm its status | DeBary | United States | Unknown status |
| Great Lakes Center of Rheumatology Coordinator of this site? Confirm its status | Lansing | United States | Unknown status |
| Atlanta Research Center for Rheumatology Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| South Coast Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| NYU School of Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Advanced Clinical Research of Orlando Coordinator of this site? Confirm its status | Ocoee | United States | Unknown status |
| Millennium Research Coordinator of this site? Confirm its status | Ormond Beach | United States | Unknown status |
| Arizona Arthritis and Rheumatology Research PLLC 1 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Arizona Arthritis and Rheumatology Research PLLC Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Trinity Universal Research Associates, LLC Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Unity Health-White County Medical Center Coordinator of this site? Confirm its status | Searcy | United States | Unknown status |
| Swedish Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Clinvest Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Jacobi Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| DM Clinical Research Coordinator of this site? Confirm its status | Tomball | United States | Unknown status |
| STAT Research, Inc. Coordinator of this site? Confirm its status | Vandalia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.