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COMPLETED
NCT03158285
PHASE3

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

741

Start Date

2017-07-12

Completion Date

2020-11-10

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DRUG

Guselkumab

Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.

DRUG

Placebo

Participants will receive matching placebo as SC injection.

Locations (138)

Rheumatology Associates

Birmingham, Alabama, United States

Arizona Arthritis & Rheumatology Associates PC

Glendale, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, United States

Clinical Research Center of Connecticut

Danbury, Connecticut, United States

Dawes Fretzin Clinical Research Group LLC

Indianapolis, Indiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Arthritis Consultants

St Louis, Missouri, United States

Austin Regional Clinic

Austin, Texas, United States

Multiprofile Hospital for Active Treatment Plovdiv

Plovdiv, Bulgaria

Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

Plovdiv, Bulgaria

Medical Center Teodora

Rousse, Bulgaria

Diagnostic Consulting Center No 17

Sofia, Bulgaria

Military Medical Academy

Sofia, Bulgaria

Medical Centre Synexus

Sofia, Bulgaria

MHAT-Targovishte, AD

Targovishte, Bulgaria

Revmaclinic

Brno, Czechia

Revmacentrum MUDr Mostera s r o

Brno-Židenice, Czechia

MUDr Rosypalova s r o

Ostrava, Czechia

Revmatologicky institut

Prague, Czechia

Revmatologicka ambulance

Prague, Czechia

Medical Plus S R O

Uherské Hradiště, Czechia

PV Medical S R O

Zlín, Czechia

Parnu Hospital

Pärnu, Estonia

OU Innomedica

Tallinn, Estonia

East Tallinn Central Hospital

Tallinn, Estonia

Clinical Research Centre

Tartu, Estonia

Daugavpils Regional Hospital

Daugavpils, Latvia

Derma Clinic Riga

Riga, Latvia

J Kisis Ltd

Riga, Latvia

Orto Clinic Ltd

Riga, Latvia

Vakk, Jsc

Kaunas, Lithuania

Siauliai Republican Hospital, Public Institution

Šiauliai, Lithuania

Central Outpatient Clinic

Vilnius, Lithuania

National Osteoporosis Centre

Vilnius, Lithuania

Hospital Selayang

Batu Caves, Malaysia

Hospital Raja Permaisuri Bainun

Ipoh, Malaysia

Sarawak General Hospital

Kuching, Malaysia

Hospital Melaka

Malacca, Malaysia

Hospital Putrajaya

Putrajaya, Malaysia

Hospital Tuanku Jaafar

Seremban, Malaysia

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, Poland

NSZOZ Unica CR

Dąbrówka, Poland

Centrum Kliniczno Badawcze

Elblag, Poland

Centrum Badan Klinicznych PI House sp z o o

Gdansk, Poland

Centrum Badawcze Wspolczesnej Terapii

Lodz, Poland

Centrum Medyczne AMED oddzial w Lodzi

Lodz, Poland

NZOZ Lecznica MAK MED S C

Nadarzyn, Poland

Etyka Osrodek Badan Klinicznych

Olsztyn, Poland

Centrum Medyczne Hetmanska

Poznan, Poland

Lubelskie Centrum Diagnostyczne

Świdnik, Poland

Nasz Lekarz Przychodnie Medyczne

Torun, Poland

Medycyna Kliniczna

Warsaw, Poland

Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

Warsaw, Poland

Centrum Medyczne AMED Targowek

Warsaw, Poland

Wro Medica

Wroclaw, Poland

Biogenes Sp z o o

Wroclaw, Poland

Chelyabinsk Regional Clinical Dermatovenerological Dispensary

Chelyabinsk, Russia

Medical and Sanitary Unit ''Severstal''

Cherepovets, Russia

Regional Clinical Hospital for War Veterans

Kemerovo, Russia

Medical Centre Maximum Health

Kemerovo, Russia

Family polyclinic #4

Korolyov, Russia

Krasnodar Clinical Dermatovenerologic Dispensary

Krasnodar, Russia

Krasnoyarsk State Medical University

Krasnoyarsk, Russia

Lipetsk Regional Dermatovenerological Dispensary

Lipetsk, Russia

Moscow State Medical and Stomatological University

Moscow, Russia

Clinical Diagnostic Center 'Ultramed'

Omsk, Russia

Orenburg State Medical University

Orenburg, Russia

Republican Hospital n.a.V.A.Baranov

Petrozavodsk, Russia

Rostov Regional Clinical Dermatovenerological Dispensary

Rostov-on-Don, Russia

Ryazan Regional Clinical Dermatovenerological Dispensary

Ryazan, Russia

City Clinic №25 - City Rheumatology Centre

Saint Petersburg, Russia

Leningrad region clinical hospital

Saint Petersburg, Russia

Saratov Regional Clinical Hospital

Saratov, Russia

Smolensk regional hospital on Smolensk railway station

Smolensk, Russia

Tula Regional Clinical Dermatovenerological Dispensary

Tula, Russia

Regional Clinical Hospital

Tver', Russia

Republican Clinical Hospital - G.G. Kuvatov

Ufa, Russia

Clinical Emergency Hospital n.a. N.V. Solovyev

Yaroslavl, Russia

Clinical Hospital #3

Yaroslavl, Russia

Clinical Hospital #10

Yaroslavl, Russia

Research Institute of Dermatovenerology, Immunology

Yekaterinburg, Russia

Hosp Univ A Coruna

A Coruña, Spain

Hosp. Univ. de Cruces

Barakaldo, Spain

Hosp. Univ. de Basurto

Bilbao, Spain

Hosp Reina Sofia

Córdoba, Spain

Hosp. Univ. Infanta Leonor

Madrid, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Regional. Carlos Haya

Málaga, Spain

Hosp. de Merida

Mérida, Spain

H.U. Infanta Sofía

San Sebastián de los Reyes, Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, Spain

Hosp. Infanta Luisa

Seville, Spain

Hosp. Unv. de Valme

Seville, Spain

Hosp. Univ. Dr. Peset

Valencia, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Hosp. Do Meixoeiro

Vigo, Spain

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Chang Gung Memorial Hospital Kaohsiung Branch

Kaohsiung City, Taiwan

National Cheng Kung University Medical Center

Tainan, Taiwan

Chang Kung Memorial Hospital

Taipei, Taiwan

Chang-Gung Memorial Hospital, LinKou Branch

Taoyuan, Taiwan

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Uludag University Medical Faculty

Bursa, Turkey (Türkiye)

Osmangazi University Medical Faculty

Eskişehir, Turkey (Türkiye)

Bakirkoy Training and Research Hospital

Istanbul, Turkey (Türkiye)

Marmara University Medical Faculty

Istanbul, Turkey (Türkiye)

Dokuz Eylul Universitesi Tip Fakultesi

Izmir, Turkey (Türkiye)

Izmir Katip Celebi University Medical Faculty Ataturk Training and Research Hospital

Izmir, Turkey (Türkiye)

Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, Ukraine

Municipal health care institution Chernihiv Regional Hospital

Chernihiv, Ukraine

Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital

Ivano-Frankivsk, Ukraine

Communal Institution of Health Kharkiv City multifield hospital №18

Kharkiv, Ukraine

Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'

Kharkiv, Ukraine

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

Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'

Kherson, Ukraine

Khmelnitckiy regional hospital

Khmelnytsky, Ukraine

City Clinical Hospital No. 2

Kryvyi Rih, Ukraine

Kyiv City Clinical Hospital #3

Kyiv, Ukraine

Medical Center 'Consylium Medical'

Kyiv, Ukraine

Kyiv Regional Clinical Hospital

Kyiv, Ukraine

Kyiv Railway Station Clinical Hospital #2

Kyiv, Ukraine

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

Kyiv, Ukraine

Danylo Haytsky Lviv National Medical University, Lviv Regional Clinical Hospital

Lviv, Ukraine

Lviv Communcal City Clinical Hospital #4

Lviv, Ukraine

Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

Odesa, Ukraine

Multidisciplinary Medical Center of Odessa National Medical University

Odesa, Ukraine

Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy

Poltava, Ukraine

Sumy State University

Sumy, Ukraine

Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

Ternopil, Ukraine

Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

Ternopil, Ukraine

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

Uzhhorod, Ukraine

Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

Vinnytsia, Ukraine

VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council

Vinnytsia, Ukraine

Zaporizhzhya Regional Clinical Hospital

Zaporizhzhya, Ukraine

Municipal institution Central Clinical Hospital #1 Zhytomir

Zhytomyr, Ukraine