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
- Diseases
- Psoriasis, Psoriatic arthritis
- 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
Sites (156)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OMI Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Central Militar Cirujano Mayor Dr Cosme Argerich Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Privado de Medicina Familiar Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Cosultorios Reumatologógicos Pampa Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CIPREC Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto de Reumatología Mendoza Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Centro de Investigaciones Medicas Tucuman Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Southern Clinical Research Coordinator of this site? Confirm its status | Hobart | Australia | Unknown status |
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Skin Health Institute Inc. Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Eastern Health - Box Hill Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Completed |
| UNIMED Medical Center EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment Kaspela EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Амбулатория За Специализирана Извънболнична Медицинска Помощ Ревматологичен Център Света Ирина ЕООD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Rheuma s.r.o. Coordinator of this site? Confirm its status | Břeclav | Czechia | Completed |
| L.K.N. Arthrocentrum, s.r.o. Coordinator of this site? Confirm its status | Hlučín | Czechia | Completed |
| ARTHROHELP s.r.o. Coordinator of this site? Confirm its status | Pardubice | Czechia | Completed |
| MUDr. Rosypalova s.r.o. Coordinator of this site? Confirm its status | Poruba | Czechia | Completed |
| Revmatologicky Ustav Coordinator of this site? Confirm its status | Prague 2 | Czechia | Completed |
| MEDICAL PLUS s.r.o. Coordinator of this site? Confirm its status | Uherské Hradiště | Czechia | Completed |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Completed |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Clínica Gaias - Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| Hospital Quironsalud Sagrado Corazon Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz Coordinator of this site? Confirm its status | Budapest II | Hungary | Completed |
| Uno Medical Trials Kft. Coordinator of this site? Confirm its status | Budapest XV | Hungary | Completed |
| Bekes Varmegyei Koezponti Korhaz Coordinator of this site? Confirm its status | Gyula | Hungary | Completed |
| Kistarcsai Flor Ferenc Korhaz Coordinator of this site? Confirm its status | Kistarcsa | Hungary | Completed |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Completed |
| Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Szekesfehervar | Hungary | Completed |
| Vital-Medicina Kft. Coordinator of this site? Confirm its status | Veszprem | Hungary | Completed |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Bnai Zion Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Hospital Selayang Coordinator of this site? Confirm its status | Batu Caves | Malaysia | Unknown status |
| Hospital Pulau Pinang Coordinator of this site? Confirm its status | George Town | Malaysia | Unknown status |
| Hospital Raja Permaisuri Bainun Coordinator of this site? Confirm its status | Ipoh | Malaysia | Unknown status |
| Hospital Tuanku Jaafar Coordinator of this site? Confirm its status | Seremban | Malaysia | Unknown status |
| Malopolskie Badania Kliniczne Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Malopolskie Centrum Kliniczne Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Coordinator of this site? Confirm its status | Elblag | Poland | Completed |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| DERMED Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| NZOZ Lecznica MAK MED S C Coordinator of this site? Confirm its status | Nadarzyn | Poland | Completed |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Nowa Sol | Poland | Completed |
| Ai Centrum Medyczne Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Klinika Reuma Park Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Rheuma Medicus Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| GCM Medical Group Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Mindful Medical Research Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| FDI Clinical Research Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Altay Medical State University Coordinator of this site? Confirm its status | Barnaul | Russia | Unknown status |
| Chelyabinck Regional Clinical Hospital Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| Chelyabinsk Regional Clinical Dermatovenerological Dispensary Coordinator of this site? Confirm its status | Chelyabinsk | Russia | 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 |
| Krasnodar Clinical Dermatovenerologic Dispensary Coordinator of this site? Confirm its status | Krasnodar | Russia | Unknown status |
| Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon Coordinator of this site? Confirm its status | Krasnoyarsk | Russia | Unknown status |
| GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi' Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Clinical-Diagnostic Center Euromedservice, JSC Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| FGBU Research Institute of Rheumatology named V.A.Nasonova Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| GBOU VPO Orenburg State Medical University 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 |
| X7 Clinical Research Company Limited Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| St. Petersburg GBUZ Clinical Reumatological Hospital 25 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Saratov regional clinical hospital Coordinator of this site? Confirm its status | Saratov | Russia | Unknown status |
| Smolensk regional hospital on Smolensk railway station Coordinator of this site? Confirm its status | Smolensk | Russia | Unknown status |
| GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5' Coordinator of this site? Confirm its status | Tolyatti | Russia | Unknown status |
| Tula Regional Clinical Dermatovenerological Dispensary Coordinator of this site? Confirm its status | Tula | Russia | Unknown status |
| Republican Clinical Hospital - G.G. Kuvatov Coordinator of this site? Confirm its status | Ufa | Russia | Unknown status |
| Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council Coordinator of this site? Confirm its status | Cherkasy | Ukraine | Unknown status |
| Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| Khmelnitckiy regional hospital Coordinator of this site? Confirm its status | Khmelnytsky | Ukraine | Unknown status |
| City Clinical Hospital No. 2 Coordinator of this site? Confirm its status | Kryvyi Rih | Ukraine | Unknown status |
| Kyiv City Clinical Hospital #3 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 |
| Medical Center LLC 'Harmony of Beauty' Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Medical Center 'Consylium Medical' Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Medical Center of 'Institute of Rheumatology', LLC Coordinator of this site? Confirm its status | Kyiv | 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 |
| Volyn Regional Clinical Hospital Coordinator of this site? Confirm its status | Lutsk | Ukraine | Unknown status |
| LLC Medical House Coordinator of this site? Confirm its status | Odesa | 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 |
| Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov 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 |
| Albuquerque Center for Rheumatology Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Arizona Arthritis and Rheumatology Research PLLC 2 Coordinator of this site? Confirm its status | Avondale | United States | Unknown status |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Bay Pines VA Healthcare System Coordinator of this site? Confirm its status | Bay Pines | United States | Unknown status |
| Rheumatology and Pulmonary Clinic Coordinator of this site? Confirm its status | Beckley | United States | Unknown status |
| DJL Clinical Research, PLLC Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Great Lakes Clinical Trials Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Clinical Research of West Florida Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Precision Comprehensive Clinical Research Solutions Coordinator of this site? Confirm its status | Colleyville | United States | Unknown status |
| Adriana Pop-Moody MD Clinic PA Coordinator of this site? Confirm its status | Corpus Christi | United States | Unknown status |
| Metroplex Clinical Research Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Clinical Research Center of Connecticut Coordinator of this site? Confirm its status | Danbury | United States | Unknown status |
| Omega Research Consultants Coordinator of this site? Confirm its status | DeBary | United States | Unknown status |
| St. Paul Rheumatology P A Coordinator of this site? Confirm its status | Eagan | United States | Unknown status |
| Arizona Arthritis and Rheumatology Research PLLC 3 Coordinator of this site? Confirm its status | Flagstaff | United States | Unknown status |
| Precision Comprehensive Clinical Research Solutions 1 Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Klein and Associates, M.D., P.A. Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Newport Huntington Medical Group Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Great Lakes Center of Rheumatology Coordinator of this site? Confirm its status | Lansing | United States | Unknown status |
| Arthritis and Osteoperosis Associates of New Mexico Coordinator of this site? Confirm its status | Las Cruces | United States | Unknown status |
| West Texas Clinical Research Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Dr. Ramesh Gupta Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Arizona Arthritis and Rheumatology Research PLLC Coordinator of this site? Confirm its status | Mesa | United States | Unknown status |
| SouthWest Rheumatology Research, LLC Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| The Arthritis and Diabetes Clinic Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| Arthritis Associates Coordinator of this site? Confirm its status | Mountain Brook | United States | Unknown status |
| Advanced Clinical Research of Orlando Coordinator of this site? Confirm its status | Ocoee | United States | Unknown status |
| Arthritis and Rheumatology Center of MI Coordinator of this site? Confirm its status | Okemos | United States | Unknown status |
| Rheumatology Associates of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Health Research of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Buffalo Rheumatology and Medicine, PLLC Coordinator of this site? Confirm its status | Orchard Park | United States | Unknown status |
| Arizona Arthritis and Rheumatology Research PLLC 1 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Texas Rheumatology Care Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Integral Rheumatology And Immunology Specialists Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Clinical Research Institute of Michigan, LLC Coordinator of this site? Confirm its status | Saint Clair Shores | United States | Unknown status |
| Unity Health-White County Medical Center Coordinator of this site? Confirm its status | Searcy | United States | Unknown status |
| Clinic of Robert Hozman Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Arthritis Northwest PLLC 1 Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Arthritis Consultants Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Arizona Arthritis and Rheumatology Associates Coordinator of this site? Confirm its status | Sun City | United States | Unknown status |
| Clinical Research of West Florida 1 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Advanced Rheumatology of Houston Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Medvin Clinical Research 2 Coordinator of this site? Confirm its status | Thousand Oaks | United States | Unknown status |
| DM Clinical Research Coordinator of this site? Confirm its status | Tomball | United States | Unknown status |
| Southern Arizona VA Healthcare System Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Medvin Clinical Research Coordinator of this site? Confirm its status | Tujunga | United States | Unknown status |
| STAT Research, Inc. Coordinator of this site? Confirm its status | Vandalia | United States | Unknown status |
| Arthritis Rheumatic And Back Disease Associates Coordinator of this site? Confirm its status | Voorhees Township | United States | Unknown status |
| Arthritis And Osteoporosis Clinic Coordinator of this site? Confirm its status | Waco | United States | Unknown status |
| Florida Medical Clinic, P.A. Coordinator of this site? Confirm its status | Zephyrhills | United States | Unknown status |
| Adana City Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Gulhane Egitim ve Arastirma Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara Bilkent City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Hacettepe University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Akdeniz Universitesi Hastanesi Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
| Bursa Uludag Universitesi Hastanesi Coordinator of this site? Confirm its status | Bursa | Turkey (Türkiye) | Unknown status |
| Pamukkale University Medical Faculty Coordinator of this site? Confirm its status | Denizli | Turkey (Türkiye) | Unknown status |
| Osmangazi University Medical Faculty Coordinator of this site? Confirm its status | Eskişehir | Turkey (Türkiye) | Unknown status |
| Marmara University Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Istanbul University Istanbul Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Kartal Dr Lutfi Kirdar Sehir Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Istanbul University Cerrahpasa Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Kocaeli University Medical Faculty Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
| Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.