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New drug combo shows promise for Tough-to-Treat psoriatic arthritis

NCT ID NCT05071664

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tested whether combining two drugs (guselkumab and golimumab) works better than one drug alone for people with active psoriatic arthritis who didn't get enough relief from previous TNF-alpha blockers. 91 adults took part. The goal was to see if the combo could help more people reach a state of minimal disease activity, meaning fewer joint and skin symptoms, less pain, and better daily function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

91 people

The number who actually took part.

Started

Oct 2021

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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) * Positive human immunodeficiency virus (HIV) antibody test

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Conditions

The condition(s) this trial relates to.

psoriatic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthritis, psoriatic

Contacts and locations

Locations

  • A.O.U.Policlinico Tor Vergata

    Roma, 00133, Italy

  • AO Ordine Mauriziano

    Torino, 10128, Italy

  • Advanced Clinical Research of Orlando

    Ocoee, Florida, 34761, United States

  • Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, 42123, Italy

  • Arizona Arthritis and Rheumatology Research PLLC

    Phoenix, Arizona, 85032, United States

  • Arizona Arthritis and Rheumatology Research PLLC 1

    Phoenix, Arizona, 85037, United States

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia, 30060, United States

  • Azienda Ospedaliero-Universitaria di Cagliari

    Cagliari, 09124, Italy

  • Bay Pines VA Healthcare System

    Bay Pines, Florida, 33744, United States

  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700, Hungary

  • CHU Trousseau - Service de Rhumatologie

    Tours, 37044, France

  • Centre Hospitalier Le Mans

    Le Mans, 72037, France

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

    Milan, 20122, Italy

  • Centrum Kliniczno Badawcze

    Elblag, 82-300, Poland

  • Centrum Medyczne

    Poznan, 61 113, Poland

  • Centrum Medyczne AMED Targowek

    Warsaw, 03 291, Poland

  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz, 90-242, Poland

  • Clinical Hospital #3

    Yaroslavl, 150007, Russia

  • Clinvest

    Springfield, Missouri, 65807, United States

  • Complex Rendelo Med Zrt

    Székesfehérvár, 8000, Hungary

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208, Spain

  • DM Clinical Research

    Tomball, Texas, 77375, United States

  • Frederiksberg Hospital

    Frederiksberg, 2000, Denmark

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

    Moscow, 129110, Russia

  • Great Lakes Center of Rheumatology

    Lansing, Michigan, 48911, United States

  • HARAC Research Corp

    Avon Park, Florida, 33825, United States

  • Health Clinic Limited Liability Company

    Vinnytsia, 21009, Ukraine

  • Hopital Larrey CHU de Toulouse

    Toulouse, 31059, France

  • Hosp Reina Sofia

    Córdoba, 14004, Spain

  • Hosp Univ A Coruna

    A Coruña, 15006, Spain

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706, Spain

  • Hosp. Infanta Luisa

    Seville, 41010, Spain

  • Hosp. Ntra. Sra. de Valme

    Seville, 41014, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Barcelona, 08916, Spain

  • Hosp. Univ. de Basurto

    Bilbao, 48013, Spain

  • Hosp. Virgen Macarena

    Seville, 41009, Spain

  • IRCCS Policlinico San Matteo, Università degli studi di Pavi

    Pavia, 27100, Italy

  • Jacobi Medical Center

    The Bronx, New York, 10461, United States

  • Karolinska Universitetssjukhuset Solna

    Solna, 171 76, Sweden

  • Kemerovo State Medical University

    Kemerovo, 650000, Russia

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

    Kyiv, 03049, Ukraine

  • Køge Sygehus Region Sjaelland

    Køge, 4600, Denmark

  • LLC Family Outpatient Clinic # 4

    Korolyov, 141060, Russia

  • LLL Medical Center Revma-Med

    Kemerovo, 650070, Russia

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

    Poltava, 36011, Ukraine

  • MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

    Uzhhorod, 88000, Ukraine

  • Medical Center LLC 'Modern Clinic'

    Zaporizhzhya, 69600, Ukraine

  • Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud

    Kyiv, 03037, Ukraine

  • Medycyna Kliniczna

    Warsaw, 00-874, Poland

  • Millennium Research

    Ormond Beach, Florida, 32174, United States

  • Municipal Institution Regional hospital-center of emergency care and disasters medicine

    Kharkiv, 61204, Ukraine

  • Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'

    Kyiv, 04107, Ukraine

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

    Ternopil, 46002, Ukraine

  • NYU Langone Ambulatory Care Brooklyn Heights

    Brooklyn, New York, 11201, United States

  • NYU School of Medicine

    New York, New York, 10016, United States

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05-830, Poland

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036, Hungary

  • Omega Research Consultants

    DeBary, Florida, 32713, United States

  • Orenburg State Medical Academy

    Orenburg, 460000, Russia

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • Republican Clinical Hospital - G.G. Kuvatov

    Ufa, 450005, Russia

  • Rigshospitalet Glostrup

    Glostrup Municipality, 2600, Denmark

  • Rostov Regional Clinical Dermatovenerological Dispensary

    Rostov-on-Don, 344007, Russia

  • Ryazan Regional Clinical Dermatovenerological Dispensary

    Ryazan, 390046, Russia

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

    Kyiv, 03680, Ukraine

  • STAT Research, Inc.

    Vandalia, Ohio, 45377, United States

  • Silkeborg Hospital

    Silkeborg, 8600, Denmark

  • Skanes universitetssjukhus

    Malmö, 205 02, Sweden

  • Smolensk regional hospital on Smolensk railway station

    Smolensk, 214025, Russia

  • South Coast Research Center

    Miami, Florida, 33136, United States

  • State Institution Institute of therapy named after L.T.Malaya AMS Ukraine

    Kharkiv, 61039, Ukraine

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Trinity Universal Research Associates, LLC

    Plano, Texas, 75024, United States

  • Unity Health-White County Medical Center

    Searcy, Arkansas, 72143, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • Università Campus Biomedico di Roma

    Rome, 00128, Italy

  • Vejle Sygehus

    Vejle, 7100, Denmark

  • Vital Medical Center

    Veszprém, 8200, Hungary

  • WroMedica I Bielicka A Strzalkowska s c

    Wroclaw, 51 685, Poland

  • X7 Clinical Research Company Limited

    Saint Petersburg, 194156, Russia

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Other studies related to the condition(s) this trial covers.