A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants With Active Psoriatic Arthritis

Who is this study for? Patients with active psoriatic arthritis
What treatments are being studied? Guselkumab
Status: Active_not_recruiting
Location: See all (261) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy

• Have a diagnosis of 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 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 \>= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read

• Have at least one 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

Locations
United States
Alabama
Rheumatology Associates
Birmingham
Arizona
Arizona Arthritis and Rheumatology Research PLLC
Flagstaff
Arizona Arthritis & Rheumatology Associates PC
Glendale
Arizona Arthritis & Rheumatology Research, PLLC
Tucson
California
Advanced Medical Research
La Palma
Rheumatology Center of San Diego
San Diego
Medvin Clinical Research, Inc.
Whittier
Florida
Heuer M.D. Research
Orlando
The Arthritis Center, Inc.
Palm Harbor
Forcare Clinical Research Inc
Tampa
Maryland
Klein And Associates M D P A
Hagerstown
Michigan
Advanced Rheumatology
Lansing
Missouri
Arthritis Consultants
St Louis
Montana
Glacier View Research Institute
Kalispell
North Carolina
PMG Research of Salisbury
Salisbury
New York
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn
Ohio
STAT Research, Inc.
Springboro
Pennsylvania
Altoona Center For Clinical Research
Duncansville
Tennessee
Dr. Ramesh Gupta
Memphis
Texas
Austin Regional Clinic
Austin
Adriana Pop Moody MD Clinic PA
Corpus Christi
Southwest Rheumatology Research LLC
Mesquite
Arthritis And Osteoporosis Clinic
Waco
Other Locations
Australia
The Queen Elizabeth Hospital
Adelaide
Southern Clinical Research
Hobart
Eastern Health - Box Hill Hospital
Melbourne
Emeritus Research
Melbourne
Rheumatology Research Unit
Sunshine Coast
Bosnia and Herzegovina
University Clinical center Republic of Srpska
Banja Luka
Health center Gradiska
Gradiška
Clinical hospital Mostar
Mostar
Clinical Center University of Sarajevo
Sarajevo
Bulgaria
Medical Center Unimed Plovdiv
Plovdiv
MHAT Trimantium
Plovdiv
Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
Plovdiv
UMHAT Kaspela
Plovdiv
Medical Center Teodora
Rousse
Medical Center Medconsult-Pleven
Sevlievo
DCC Convex EOOD
Sofia
DCC XVII-Sofia EOOD
Sofia
Medical Center Hera EOOD
Sofia
St Ivan Rilski University Multiprofile Hospital For Active Treatment
Sofia
UMHAT St. Ivan Rilski
Sofia
UMHAT Sv. Ivan Rilski
Sofia
Canada
Group De Recherche En Rhumatologie Et Maladies Osseuses
Québec
Eastern Regional Health Authority St Clares Mercy Hospital
St. John's
Toronto Western Hospital
Toronto
Centre de Recherche Musculo Squelettique
Trois-rivières
China
Affiliated Hospital of Hebei University
Baoding
The First Affiliated Hospital of Baotou Medical University
Baotou
Peking Union Medical College Hospital
Beijing
Peking University First Hospital
Beijing
Peking University Third Hospital
Beijing
The Affiliated Hospital of Bengbu Medical College
Bengbu
The First Bethune Hospital of Jilin University
Changchun
Changzhou No 2 Peoples Hospital
Changzhou
West China Hospital of Sichuan University
Chengdu
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Guangzhou First Municipal People's Hospital
Guangzhou
the 3rd Affiliated Hospital,Sun Yansen University
Guangzhou
The Affiliated Hospital of Guizhou Medical University
Guiyang
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou
Linyi City People Hospital
Linyi
The First Affiliated Hospital of NanChang University
Nanchang
The Second Affiliated Hospital of Nanchang University
Nanchang
Nanjing Drum Tower Hospital
Nanjing
Pingxiang People's Hospital
Pingxiang
Huashan Hospital Fudan University
Shanghai
Shanghai skin disease hospital
Shanghai
Shengjing Hospital Of China Medical University
Shenyang
The hospital of Shanxi Universtidy
Taiyuan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Croatia
Ch Osijek
Osijek
KBC Rijeka
Rijeka
University Hospital Center Split
Split
Klinicki bolnicki centar Zagreb
Zagreb
Medicinski centar Kuna & Peric
Zagreb
University Hospital Sveti Duh
Zagreb
Estonia
North Estonia Medical Centre
Tallinn
OU Innomedica
Tallinn
Sihtasutus Tartu Ulikooli Kliinikum - Nahahaiguste Kliinik
Tartu
Georgia
LTD Unimed Adjara
Batumi
LTD Clinic LJ
Kutaisi
Aleksandre Aladashvili Clinic LLC
Tbilisi
Aleksandre Aladashvili Clinic LLC
Tbilisi
Consilium Medulla-multiprofile clinic Ltd
Tbilisi
J S C K Eristavi National Cen
Tbilisi
JSC Evex Hospitals
Tbilisi
LTD MediClub Georgia
Tbilisi
Ltd Medicore
Tbilisi
LTD The First Medical Center
Tbilisi
Raymann Ltd
Tbilisi
Tbilisi Heart and Vascular Clinic Ltd
Tbilisi
Germany
Rheumatologische Schwerpunktpraxis
Berlin
Hamburger Rheuma Forschungszentrum II
Hamburg
Praxis fur Klinische Studien und Praxis fur Orthopadie
Hamburg
Rheumazentrum Ruhrgebiet
Herne
Institut Fur Praventive Medizin Klinische Forschung GbR
Magdeburg
Gemeinschaftspraxis Dres. Quist
Mainz
Rheumazentrum Ratingen
Ratingen
Greece
Hippokration Hospital
Athens
Laiko General Hospital of Athens
Athens
Naval Hospital of Athens
Athens
University Hospital Of Larissa, Biopolis
Larissa
Democritus University of Thrace
Xánthi
Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest
Qualiclinic Kft
Budapest
Revita Rendelo
Budapest
Uno Medical Trials Ltd.
Budapest
Debreceni Egyetem Klinikai Kozpont
Debrecen
Synexus Magyarorszag Kft
Gyula
Pest Megyei Flor Ferenc Korhaz
Kistarcsa
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
Szeged
Csongrád Megyei Dr. Bugyi István Kórház
Szentes
MAV Korhaz es Rendelointezet
Szolnok
Synexus Magyarorszag Kft
Zalaegerszeg
Israel
Barzilai Medical Center
Ashkelon
Bnai Zion Medical Center
Haifa
Rambam Health Care Campus
Haifa
Meir Medical Center
Kfar Saba
Rabin Medical Center Beilinson Campus
Petah Tikva
The Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania
Ospedale San Raffaele, IRCCS
Milan
AOU Università degli Studi della Campania L. Vanvitelli
Napoli
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo
Università di Roma La Sapienza
Roma
Complesso Integrato Columbus
Rome
A.O.U. Città della Salute e della Scienza
Torino
Azienda Ospedaliera Universitaria Integrata Verona
Verona
Latvia
M & M Centrs Ltd
Ādaži
J Kisis Ltd
Riga
Orto Clinic Ltd
Riga
P. Stradina Clinical University Hospital
Riga
Riga 1st Hospital
Riga
Riga East Clinical University Hospital
Riga
Lithuania
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas
Practice Dr Pociene Gilvina
Kaunas
Klaipeda University Hospital
Klaipėda
Siauliai Republican Hospital, Public Institution
Šiauliai
JSC Inlita, Santaros KTC
Vilnius
Malaysia
Hospital Selayang
Batu Caves
Hospital Raja Permaisuri Bainun
Ipoh
University Malaya Medical Centre
Kuala Lumpur
Hospital Melaka
Malacca
Sunway Medical Centre
Petaling Jaya
Hospital Tuanku Jaafar
Seremban
Philippines
Angeles University Foundation Medical Center
Angeles
Cebu Doctors' University Hospital
Cebu
De La Salle University Medical Center
Dasmariñas
Davao Doctors Hospital
Davao City
Southern Philippines Medical Center
Davao City
University of Perpetual Help Dalta Medical Center, Inc
Las Piñas
Manila Doctors Hospital
Manila
Medical Center Manila
Manila
Philippine General Hospital
Manila
Poland
ClinicMed Badurski i Wspolnicy Spolka Jawna
Bialystok
Osteo-Medic s.c A. Racewicz, J Supronik
Bialystok
Nasz Lekarz Przychodnie Medyczne
Bydgoszcz
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz
Ambulatorium Barbara Bazela
Elblag
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag
Medica Pro Familia sp z o o S K A
Gdynia
Pratia MCM Krakow
Krakow
REUMED Zespol Poradni Specjalistycznych Filia nr 2
Lublin
NZOZ Lecznica Mak-Med sc
Nadarzyn
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól
Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj
Poznan
Nasz Lekarz Przychodnie Medyczne
Torun
Medycyna Kliniczna
Warsaw
Reumatika-Centrum Reumatologii, NZOZ
Warsaw
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw
DERMMEDICA Sp.z o.o.
Wroclaw
Republic of Korea
Soonchunhyang University Cheonan Hospital
Cheonan-si
Chonnam National University Hospital
Gwangju
Asan Medical Center
Seoul
Hanyang University Hospital
Seoul
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital
Seoul
Ajou University Hospital
Suwon
Russian Federation
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk
LLC Aliance Biomedical-Ural group
Izhevsk
State Budgetary Educational Institution of High Professional Education
Kazan'
Medical Center LLC Maxsimum Zdoroviya
Kemerovo
FGBU Research Institute of Rheumatology named V.A.Nasonova
Moscow
GU Moscow Regional Research Clinical Institute n.a. M.F.Vla
Moscow
GUZ of Moscow City Clinical Hospital # 1 n.a.N.I.Pirogov
Moscow
LLC Family Outpatient Clinic # 4
Moscow
LLC Consultative and Diagnostic Center of Rheumatology Heal
Novosibirsk
GBUZ Orenburg Clinical Regional Hospital
Orenburg
Republican Hospital n.a.V.A.Baranov
Petrozavodsk
Ryazan Regional Clinical Cardiology Center
Ryazan
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan
Ryazan Regional Clinical Hospital
Ryazan
Federal North-West Medical Research Centre
Saint Petersburg
LLC Sanavita
Saint Petersburg
Northen-Western State Medical University n.a. I.I. Mechnikov
Saint Petersburg
Sararov Regional Clinical Hospital
Saratov
Ulyanovsk Regional Clinical Hospital
Ulyanovsk
State Budget Healthcare Institution of Vladimir Region Regional Clinical Hospital
Vladimir
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl
Clinical Hospital #3
Yaroslavl
Serbia
Institute of Rheumatology
Belgrade
Military Medical Academy
Belgrade
University Clinical Center Kragujevac
Kragujevac
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja
Special Hospital for Rheumatic Diseases
Novi Sad
Slovakia
Paediatric University Hospital
Košice
Reumatologicka ambulancia
Martin
Chiremed, s.r.o.
Púchov
Reumex s.r.o
Rimavská Sobota
Slovenia
Splosna bolnisnica Izola
Izo
Bolnica Dr. Petra Drzaja
Ljubljana
UKC Maribor Dermatology clinic
Maribor
Spain
Hosp Univ A Coruna
A Coruña
Hosp Reina Sofia
Córdoba
Hosp. Univ. 12 de Octubre
Madrid
Hosp Regional Univ de Malaga
Málaga
Hosp. Univ. de Mostoles
Móstoles
Hosp. Univ. Virgen de La Arrixaca
Murcia
Hosp. Univ. Infanta Sofia
San Sebastián De Los Reyes
Complejo Hospitalario Universitario de Santiago. Servicio de Aparato Digestivo
Santiago De Compostela
Hosp. Clinico Univ. de Santiago
Santiago De Compostela
Hosp. Nuestra Senora de La Esperanza
Santiago De Compostela
Hosp. Infanta Luisa
Seville
Hosp. Virgen Macarena
Seville
Taiwan
Chang Gung Medical Foundation
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
China Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan District
National Taiwan University Hospital
Taoyuan District
Chi Mei Medical Center Yong Kang
Yung-kang
Turkey
Akdeniz University Medical Faculty
Istanbul
Izmir Katip Celebi University
Izmir
Kocaeli University Medical Faculty
Kocaeli
Selcuk University Medical Faculty
Konya
Ukraine
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy
Derzhavna ustanova Natsionalnyi instytut terapii imeni L.T.Maloi NAMN Ukrainy viddil klinichnoi
Kharkiv
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv
Khmelnitska oblasna likarnia
Khmelnitsky
TOV Revmocentr
Kiev
Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi rady
Kryvyi Rih
Center of Family Medicine Plus LLC
Kyiv
Kyiv Railway Station Clinical Hospital #2
Kyiv
Kyivska oblasna klinichna likarnia
Kyiv
Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
Kyiv
Olexandrivska Clinical Hospital of Kyiv City
Kyiv
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv
State Institution Railway clinical Hospital 2
Kyiv
Multidisciplinary Medical Center of Odessa National Medical University
Odesa
Odeska oblasna klinichna likarnia
Odesa
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
Poltava
Sumska oblasna klinichna likarnia
Sumy
Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
Ternopil
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
Vinnytsia
Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
Vinnytsia
Zhytomyr Central City Hospital #1
Zhytomyr
Time Frame
Start Date: 2021-06-17
Completion Date: 2028-05-19
Participants
Target number of participants: 1054
Treatments
Experimental: Group 1: Guselkumab and Placebo
Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.
Experimental: Group 2: Guselkumab
Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Experimental: Group 3: Placebo Followed by Guselkumab
Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov