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ACTIVE NOT RECRUITING
NCT04929210
PHASE4

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.

Official title: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

411

Start Date

2021-08-30

Completion Date

2027-04-13

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Guselkumab

Guselkumab will be administered as subcutaneous injection.

DRUG

Placebo

Matching placebo will be administered as subcutaneous injection.

Locations (240)

Arizona Arthritis and Rheumatology Research PLLC 1

Avondale, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Chandler, Arizona, United States

Arizona Arthritis and Rheumatology Research PLLC

Mesa, Arizona, United States

Arizona Arthritis Research, PLC.

Phoenix, Arizona, United States

Arizona Arthritis and Rheumatology Associates

Sun City, Arizona, United States

Southern Arizona VA Healthcare System

Tucson, Arizona, United States

Unity Health-White County Medical Center

Searcy, Arkansas, United States

Kaiser Permanent Medical Center

Fontana, California, United States

Newport Huntington Medical Group

Huntington Beach, California, United States

University Of California San Diego

La Jolla, California, United States

Rheumatology Center of San Diego

San Diego, California, United States

Clinical Research Center of Connecticut

Danbury, Connecticut, United States

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Integral Rheumatology And Immunology Specialists

Plantation, Florida, United States

Florida Medical Clinic, P.A.

Zephyrhills, Florida, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

OrthoIllinois

Rockford, Illinois, United States

Willow Rheumatology and Wellness

Willowbrook, Illinois, United States

Johns Hopkins Bayview Medical

Baltimore, Maryland, United States

Klein And Associates M D P A

Hagerstown, Maryland, United States

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, United States

St. Paul Rheumatology P A

Eagan, Minnesota, United States

Kansas City Physician Partners

Kansas City, Missouri, United States

Clinvest

Springfield, Missouri, United States

STAT Research, Inc.

Vandalia, Ohio, United States

OHSU Rheumatology Clinic, Marquam Hill

Portland, Oregon, United States

Amarillo Center for Clinical Research

Amarillo, Texas, United States

Austin Regional Clinic

Austin, Texas, United States

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States

Adriana Pop Moody MD Clinic PA

Corpus Christi, Texas, United States

AARA Clinical Research Lone Star Arthritis and Rheumatology 1

Fort Worth, Texas, United States

UT Physicians Center for Autoimmunity

Houston, Texas, United States

AARA Clinical Research Lone Star Arthritis and Rheumatology

Irving, Texas, United States

West Texas Clinical Research

Lubbock, Texas, United States

Southwest Rheumatology Research LLC

Mesquite, Texas, United States

Epic Medical Research

Red Oak, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Cosultorios Reumatologógicos Pampa

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Centro Privado de Medicina Familiar

Buenos Aires, Argentina

Hospital Italiano La Plata

La Plata, Argentina

MR Medicina Reumatologica

San Fernando, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Argentina

Emeritus Research

Camberwell, Australia

Southern Clinical Research

Hobart, Australia

Liverpool Hospital

Liverpool, Australia

Rheumatology Research Unit

Maroochydore, Australia

Skin Health Institute Inc.

Melbourne, Australia

Eastern Health - Box Hill Hospital

Melbourne, Australia

Exacta Medica

Pleven, Bulgaria

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, Bulgaria

Medical Center Unimed Plovdiv

Plovdiv, Bulgaria

UMHAT Kaspela

Plovdiv, Bulgaria

Medical Center Artmed

Plovdiv, Bulgaria

MHAT 'Lyulin' EAD

Sofia, Bulgaria

University Multiprofile Hospital Sofiamed Sofia

Sofia, Bulgaria

Military Medical Academy

Sofia, Bulgaria

UMHAT St. Ivan Rilski

Sofia, Bulgaria

DCC Convex EOOD

Sofia, Bulgaria

ASIMP Rheumatology Centre St Irina EOOD

Sofia, Bulgaria

Medical Centre Synexus

Sofia, Bulgaria

DDC Sv. Ivan Rilski OOD

Targovishte, Bulgaria

Skin Care Centre

Vancouver, British Columbia, Canada

Eastern Regional Health Authority St Clares Mercy Hospital

St. John's, Newfoundland and Labrador, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

G R M O Groupe de recherche en maladies osseuses Inc

Québec, Quebec, Canada

Revmaclinic

Brno, Czechia

Revmatologie s r o

Brno, Czechia

Revmacentrum MUDr Mostera s r o

Brno-Židenice, Czechia

L K N Arthrocentrum

Hlučín, Czechia

Revimex Pro s r o

Karvina Frystat, Czechia

MUDr Rosypalova s r o

Ostrava, Czechia

Arthrohelp S.R.O.

Pardubice, Czechia

Revmatologicky ustav

Prague, Czechia

Medical Plus S R O

Uherské Hradiště, Czechia

Frederiksberg Hospital

Frederiksberg, Denmark

Rigshospitalet Glostrup

Glostrup Municipality, Denmark

Køge Sygehus Region Sjaelland

Køge, Denmark

Vejle Sygehus

Vejle, Denmark

Ltd Health Center

Batumi, Georgia

LTD Clinic LJ

Kutaisi, Georgia

Aleksandre Aladashvili Clinic LLC

Tbilisi, Georgia

Ltd American Hospital Network

Tbilisi, Georgia

LTD Helsicore

Tbilisi, Georgia

Ltd New Hospitals

Tbilisi, Georgia

TSMU The First University Clinic

Tbilisi, Georgia

JSC K Eristavi National Center of experimental and Clinical surgery

Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic Ltd

Tbilisi, Georgia

LTD 'Aversi Clinic'

Tbilisi, Georgia

LTD MediClub Georgia

Tbilisi, Georgia

Clinic on Mtskheta Street

Tbilisi, Georgia

LTD The First Medical Center

Tbilisi, Georgia

Consilium Medulla-multiprofile clinic Ltd

Tbilisi, Georgia

JSC Evex Hospitals

Tnilisi, Georgia

ISA - Interdisciplinary Study Association GmbH

Berlin, Germany

Hamburger Rheuma Forschungszentrum II

Hamburg, Germany

Rheumazentrum Ruhrgebiet

Herne, Germany

Rheumazentrum Ratingen

Ratingen, Germany

Prince Of Wales Hospital

Hong Kong, Hong Kong

And 140 more locations on ClinicalTrials.gov