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COMPLETED
NCT05071664
PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

91

Start Date

2021-10-25

Completion Date

2024-08-06

Last Updated

2026-07-23

Healthy Volunteers

No

Interventions

DRUG

Guselkumab

Guselkumab will be administered as a SC injection.

DRUG

Golimumab

Golimumab will be administered as a SC injection.

DRUG

Placebo

Placebo will be administered as a SC injection.

Locations (82)

Arizona Arthritis and Rheumatology Research PLLC

Phoenix, Arizona, United States

Arizona Arthritis and Rheumatology Research PLLC 1

Phoenix, Arizona, United States

Unity Health-White County Medical Center

Searcy, Arkansas, United States

HARAC Research Corp

Avon Park, Florida, United States

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Omega Research Consultants

DeBary, Florida, United States

South Coast Research Center

Miami, Florida, United States

Advanced Clinical Research of Orlando

Ocoee, Florida, United States

Millennium Research

Ormond Beach, Florida, United States

Atlanta Research Center for Rheumatology

Marietta, Georgia, United States

Great Lakes Center of Rheumatology

Lansing, Michigan, United States

Clinvest

Springfield, Missouri, United States

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, United States

NYU School of Medicine

New York, New York, United States

University of Rochester

Rochester, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

STAT Research, Inc.

Vandalia, Ohio, United States

Trinity Universal Research Associates, LLC

Plano, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Frederiksberg Hospital

Frederiksberg, Denmark

Rigshospitalet Glostrup

Glostrup Municipality, Denmark

Køge Sygehus Region Sjaelland

Køge, Denmark

Silkeborg Hospital

Silkeborg, Denmark

Vejle Sygehus

Vejle, Denmark

Centre Hospitalier Le Mans

Le Mans, France

Hopital Larrey CHU de Toulouse

Toulouse, France

CHU Trousseau - Service de Rhumatologie

Tours, France

Obudai Egeszsegugyi Centrum Kft

Budapest, Hungary

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, Hungary

Complex Rendelo Med Zrt

Székesfehérvár, Hungary

Vital Medical Center

Veszprém, Hungary

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, Italy

Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

Milan, Italy

Ospedale San Raffaele

Milan, Italy

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, Italy

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, Italy

A.O.U.Policlinico Tor Vergata

Roma, Italy

Policlinico Universitario Agostino Gemelli

Roma, Italy

Università Campus Biomedico di Roma

Rome, Italy

AO Ordine Mauriziano

Torino, Italy

Centrum Kliniczno Badawcze

Elblag, Poland

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, Poland

NZOZ Lecznica MAK MED S C

Nadarzyn, Poland

Centrum Medyczne

Poznan, Poland

Medycyna Kliniczna

Warsaw, Poland

Centrum Medyczne AMED Targowek

Warsaw, Poland

WroMedica I Bielicka A Strzalkowska s c

Wroclaw, Poland

Kemerovo State Medical University

Kemerovo, Russia

LLL Medical Center Revma-Med

Kemerovo, Russia

LLC Family Outpatient Clinic # 4

Korolyov, Russia

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

Moscow, Russia

Orenburg State Medical Academy

Orenburg, Russia

Rostov Regional Clinical Dermatovenerological Dispensary

Rostov-on-Don, Russia

Ryazan Regional Clinical Dermatovenerological Dispensary

Ryazan, Russia

X7 Clinical Research Company Limited

Saint Petersburg, Russia

Smolensk regional hospital on Smolensk railway station

Smolensk, Russia

Republican Clinical Hospital - G.G. Kuvatov

Ufa, Russia

Clinical Hospital #3

Yaroslavl, Russia

Hosp Univ A Coruna

A Coruña, Spain

Hosp. Univ. Germans Trias I Pujol

Barcelona, Spain

Hosp. Univ. de Basurto

Bilbao, Spain

Hosp Reina Sofia

Córdoba, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Corporacio Sanitari Parc Tauli

Sabadell, Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, Spain

Hosp. Virgen Macarena

Seville, Spain

Hosp. Infanta Luisa

Seville, Spain

Hosp. Ntra. Sra. de Valme

Seville, Spain

Skanes universitetssjukhus

Malmö, Sweden

Karolinska Universitetssjukhuset Solna

Solna, Sweden

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

Kharkiv, Ukraine

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

Kharkiv, Ukraine

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

Kyiv, Ukraine

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

Kyiv, Ukraine

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

Kyiv, Ukraine

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

Kyiv, Ukraine

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

Poltava, Ukraine

Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

Ternopil, Ukraine

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

Uzhhorod, Ukraine

Health Clinic Limited Liability Company

Vinnytsia, Ukraine

Medical Center LLC 'Modern Clinic'

Zaporizhzhya, Ukraine