Clinical trial NCT04882098: A Study of Guselkumab in Participants With Active Psoriatic Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Arthritis, Psoriatic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 1054
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients
* Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease
* Has previously received any biologic treatment
* Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor
* Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention

Primary outcomes:
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24
timeFrame: Baseline and Week 24
measure: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability
timeFrame: Up to 168 weeks
measure: Number of Participants with AEs leading to Discontinuation of Study Intervention
timeFrame: Up to 168 weeks
measure: Number of Participants with Infections
timeFrame: Up to 168 weeks
measure: Number of Participants with AEs Temporally Associated With an Injection-site Reactions
timeFrame: Up to 168 weeks
measure: Number of Participants With Change from Baseline in Clinical Laboratory Abnormalities
timeFrame: Baseline, up to 168 weeks
measure: Number of Participants with Maximum Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade Laboratory Values
timeFrame: Up to 168 weeks
measure: Serum Guselkumab Concentration
timeFrame: Up to 168 weeks
measure: Number of Participants with Anti-guselkumab Antibodies
timeFrame: Up to 168 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Rheumatology Associates
state: Alabama
city: Flagstaff
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Associates PC
state: Arizona
city: Tucson
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: La Palma
country: United States
facility: Advanced Medical Research
state: California
city: San Diego
country: United States
facility: Rheumatology Center of San Diego
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research, Inc.
state: California
city: Orlando
country: United States
facility: Heuer M.D. Research
state: Florida
city: Palm Harbor
country: United States
facility: The Arthritis Center, Inc.
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research Inc
state: Florida
city: Hagerstown
country: United States
facility: Klein And Associates M D P A
state: Maryland
city: Lansing
country: United States
facility: Advanced Rheumatology
state: Michigan
city: Saint Louis
country: United States
facility: Arthritis Consultants
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute
state: Montana
city: Brooklyn
country: United States
facility: NYU Langone Ambulatory Care Brooklyn Heights
state: New York
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Springboro
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Memphis
country: United States
facility: Dr. Ramesh Gupta
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Corpus Christi
country: United States
facility: Adriana Pop Moody MD Clinic PA
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research LLC
state: Texas
city: Waco
country: United States
facility: Arthritis And Osteoporosis Clinic
state: Texas
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
city: Hobart
country: Australia
facility: Southern Clinical Research
city: Melbourne
country: Australia
facility: Emeritus Research
city: Melbourne
country: Australia
facility: Eastern Health - Box Hill Hospital
city: Sunshine Coast
country: Australia
facility: Rheumatology Research Unit
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical center Republic of Srpska
city: Gradiska
country: Bosnia and Herzegovina
facility: Health center Gradiska
city: Mostar
country: Bosnia and Herzegovina
facility: Clinical hospital Mostar
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela
city: Plovdiv
country: Bulgaria
facility: MHAT Trimantium
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Plovdiv
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
city: Plovdiv
country: Bulgaria
facility: Medical Center Unimed Plovdiv
city: Ruse
country: Bulgaria
facility: Medical Center Teodora
city: Sevlievo
country: Bulgaria
facility: Medical Center Medconsult-Pleven
city: Sofia
country: Bulgaria
facility: UMHAT Sv. Ivan Rilski
city: Sofia
country: Bulgaria
facility: UMHAT St. Ivan Rilski
city: Sofia
country: Bulgaria
facility: DCC XVII-Sofia EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: St Ivan Rilski University Multiprofile Hospital For Active Treatment
city: Sofia
country: Bulgaria
facility: DCC Convex EOOD
city: St Johns
country: Canada
facility: Eastern Regional Health Authority St Clares Mercy Hospital
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Trois Rivieres
country: Canada
facility: Centre de Recherche Musculo Squelettique
state: Quebec
city: Quebec
country: Canada
facility: Group De Recherche En Rhumatologie Et Maladies Osseuses
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Bengbu
country: China
facility: The Affiliated Hospital of Bengbu Medical College
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: Changzhou
country: China
facility: Changzhou No 2 Peoples Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Guangzhou
country: China
facility: the 3rd Affiliated Hospital,Sun Yansen University
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Linyi
country: China
facility: Linyi City People Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of NanChang University
city: Nanchang
country: China
facility: The Second Affiliatde Hospital To Nanchang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai skin disease hospital
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Taiyuan
country: China
facility: The hospital of Shanxi Universtidy
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Osijek
country: Croatia
facility: Ch Osijek
city: Rijeka
country: Croatia
facility: KBC Rijeka
city: Split
country: Croatia
facility: University Hospital Center Split
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb
city: Zagreb
country: Croatia
facility: Medicinski centar Kuna & Peric
city: Zagreb
country: Croatia
facility: University Hospital Sveti Duh
city: Brno Zidenice
country: Czechia
facility: Revmacentrum MUDr Mostera s r o
city: Brno
country: Czechia
facility: Revmaclinic
city: Brno
country: Czechia
facility: Revmatologie s r o
city: Hlucin
country: Czechia
facility: L K N Arthrocentrum
city: Ostrava
country: Czechia
facility: CCBR Ostrava s r o
city: Ostrava
country: Czechia
facility: MUDr Rosypalova s r o
city: Pardubice
country: Czechia
facility: CCBR Klinicka centra Czech, a.s.
city: Prague
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Praha
country: Czechia
facility: Revmatologicky institut
city: Praha
country: Czechia
facility: CCR Prague s.r.o.
city: Praha
country: Czechia
facility: Affidea Praha s r o
city: Uherske Hradiste
country: Czechia
facility: Medical Plus S R O
city: Zlin
country: Czechia
facility: PV Medical S R O
city: Tallinn
country: Estonia
facility: OU Innomedica
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre
city: Tartu
country: Estonia
facility: Sihtasutus Tartu Ulikooli Kliinikum - Nahahaiguste Kliinik
city: Batumi
country: Georgia
facility: LTD Unimed Adjara
city: Kutaisi
country: Georgia
facility: LTD Clinic LJ
city: Tbilisi
country: Georgia
facility: Aleksandre Aladashvili Clinic LLC
city: Tbilisi
country: Georgia
facility: Raymann Ltd
city: Tbilisi
country: Georgia
facility: J S C K Eristavi National Cen
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic Ltd
city: Tbilisi
country: Georgia
facility: LTD MediClub Georgia
city: Tbilisi
country: Georgia
facility: Consilium Medulla-multiprofile clinic Ltd
city: Tbilisi
country: Georgia
facility: Ltd Medicore
city: Tbilisi
country: Georgia
facility: Aleksandre Aladashvili Clinic LLC
city: Tbilisi
country: Georgia
facility: JSC Evex Hospitals
city: Tbilisi
country: Georgia
facility: LTD The First Medical Center
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis
city: Hamburg
country: Germany
facility: Hamburger Rheuma Forschungszentrum II
city: Hamburg
country: Germany
facility: Praxis fur Klinische Studien und Praxis fur Orthopadie
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Magdeburg
country: Germany
facility: Institut Fur Praventive Medizin Klinische Forschung GbR
city: Mainz
country: Germany
facility: Gemeinschaftspraxis Dres. Quist
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen
city: Athens
country: Greece
facility: Naval Hospital of Athens
city: Athens
country: Greece
facility: Hippokration Hospital
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Larissa
country: Greece
facility: University Hospital Of Larissa, Biopolis
city: Xanthi
country: Greece
facility: Democritus University of Thrace
city: Budapest
country: Hungary
facility: Revita Rendelo
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Uno Medical Trials Ltd.
city: Budapest
country: Hungary
facility: Qualiclinic Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Synexus Magyarorszag Kft
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
city: Szentes
country: Hungary
facility: Csongrád Megyei Dr. Bugyi István Kórház
city: Szolnok
country: Hungary
facility: MAV Korhaz es Rendelointezet
city: Zalaegerszeg
country: Hungary
facility: Synexus Magyarorszag Kft
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Beilinson Campus
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Catania
country: Italy
facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
city: Milano
country: Italy
facility: Ospedale San Raffaele, IRCCS
city: Napoli
country: Italy
facility: AOU Università degli Studi della Campania L. Vanvitelli
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Roma
country: Italy
facility: Università di Roma La Sapienza
city: Rome
country: Italy
facility: Complesso Integrato Columbus
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Cheonan-si
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
city: Gwangju-si
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Adazi
country: Latvia
facility: M & M Centrs Ltd
city: Riga
country: Latvia
facility: P. Stradina Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital
city: Riga
country: Latvia
facility: Riga 1st Hospital
city: Riga
country: Latvia
facility: J Kisis Ltd
city: Riga
country: Latvia
facility: Orto Clinic Ltd
city: Kaunas
country: Lithuania
facility: Practice Dr Pociene Gilvina
city: Kaunas
country: Lithuania
facility: Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Siauliai
country: Lithuania
facility: Siauliai Republican Hospital, Public Institution
city: Vilnius
country: Lithuania
facility: JSC Inlita, Santaros KTC
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Melaka
country: Malaysia
facility: Hospital Melaka
city: Petaling Jaya
country: Malaysia
facility: Sunway Medical Centre
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
city: Angeles
country: Philippines
facility: Angeles University Foundation Medical Center
city: Cebu
country: Philippines
facility: Cebu Doctors' University Hospital
city: Dasmarinas
country: Philippines
facility: De La Salle University Medical Center
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Davao
country: Philippines
facility: Southern Philippines Medical Center
city: Las Pinas
country: Philippines
facility: University of Perpetual Help Dalta Medical Center, Inc
city: Manila
country: Philippines
facility: Manila Doctors Hospital
city: Manila
country: Philippines
facility: Medical Center Manila
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Bialystok
country: Poland
facility: Osteo-Medic s.c A. Racewicz, J Supronik
city: Bialystok
country: Poland
facility: ClinicMed Badurski i Wspolnicy Spolka Jawna
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
city: Elblag
country: Poland
facility: Ambulatorium Barbara Bazela
city: Gdynia
country: Poland
facility: Medica Pro Familia sp z o o S K A
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Lublin
country: Poland
facility: REUMED Zespol Poradni Specjalistycznych Filia nr 2
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica Mak-Med sc
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj
city: Torun
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne
city: Warsaw
country: Poland
facility: Medycyna Kliniczna
city: Warszawa
country: Poland
facility: Rheuma Medicus Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Reumatika-Centrum Reumatologii, NZOZ
city: Wroclaw
country: Poland
facility: DERMMEDICA Sp.z o.o.
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Dermatovenerological Dispensary
city: Izhevsk
country: Russian Federation
facility: LLC Aliance Biomedical-Ural group
city: Kazan
country: Russian Federation
facility: State Budgetary Educational Institution of High Professional Education
city: Kemerovo
country: Russian Federation
facility: Medical Center LLC Maxsimum Zdoroviya
city: Moscow
country: Russian Federation
facility: LLC Family Outpatient Clinic # 4
city: Moscow
country: Russian Federation
facility: GUZ of Moscow City Clinical Hospital # 1 n.a.N.I.Pirogov
city: Moscow
country: Russian Federation
facility: GU Moscow Regional Research Clinical Institute n.a. M.F.Vla
city: Moscow
country: Russian Federation
facility: FGBU Research Institute of Rheumatology named V.A.Nasonova
city: Novosibirsk
country: Russian Federation
facility: LLC Consultative and Diagnostic Center of Rheumatology Heal
city: Orenburg
country: Russian Federation
facility: GBUZ Orenburg Clinical Regional Hospital
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital n.a.V.A.Baranov
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Dermatovenerological Dispensary
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Cardiology Center
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Hospital
city: Sankt-Petersburg.
country: Russian Federation
facility: LLC Sanavita
city: Saratov
country: Russian Federation
facility: Sararov Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Federal North-West Medical Research Centre
city: St.-Petersburg
country: Russian Federation
facility: Northen-Western State Medical University n.a. I.I. Mechnikov
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clinical Hospital
city: Vladimir
country: Russian Federation
facility: State Budget Healthcare Institution of Vladimir Region Regional Clinical Hospital
city: Yaroslavl
country: Russian Federation
facility: Clinical Emergency Hospital n.a. N.V. Solovyev
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital #3
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Niska Banja
country: Serbia
facility: Institute for Treatment and Rehabilitation Niska Banja
city: Novi Sad
country: Serbia
facility: Special Hospital for Rheumatic Diseases
city: Kosice
country: Slovakia
facility: Paediatric University Hospital
city: Martin
country: Slovakia
facility: Reumatologicka ambulancia
city: Puchov
country: Slovakia
facility: Chiremed, s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: Reumex s.r.o
city: Izo
country: Slovenia
facility: Splosna bolnisnica Izola
city: Ljubljana
country: Slovenia
facility: Bolnica Dr. Petra Drzaja
city: Maribor
country: Slovenia
facility: UKC Maribor Dermatology clinic
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Malaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Murcia
country: Spain
facility: Hosp. Univ. Virgen de La Arrixaca
city: Móstoles
country: Spain
facility: Hosp. Univ. de Mostoles
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago. Servicio de Aparato Digestivo
city: Santiago de Compostela
country: Spain
facility: Hosp. Nuestra Senora de La Esperanza
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Sevilla
country: Spain
facility: Hosp. Infanta Luisa
city: Hsin Chu
country: Taiwan
facility: National Taiwan University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Tao-Yuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Yung-Kang
country: Taiwan
facility: Chi Mei Medical Center Yong Kang
city: Istanbul
country: Turkey
facility: Akdeniz University Medical Faculty
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Konya
country: Turkey
facility: Selcuk University Medical Faculty
city: Cherkasy
country: Ukraine
facility: Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
city: Kharkiv
country: Ukraine
facility: Derzhavna ustanova Natsionalnyi instytut terapii imeni L.T.Maloi NAMN Ukrainy viddil klinichnoi
city: Kharkiv
country: Ukraine
facility: Municipal Institution Regional hospital-center of emergency care and disasters medicine
city: Khmelnitsky
country: Ukraine
facility: Khmelnitska oblasna likarnia
city: Kiev
country: Ukraine
facility: TOV Revmocentr
city: Kryvyi Rih
country: Ukraine
facility: Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi rady
city: Kyiv
country: Ukraine
facility: Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
city: Kyiv
country: Ukraine
facility: State Institution Railway clinical Hospital 2
city: Kyiv
country: Ukraine
facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: Olexandrivska Clinical Hospital of Kyiv City
city: Kyiv
country: Ukraine
facility: Kyivska oblasna klinichna likarnia
city: Kyiv
country: Ukraine
facility: Center of Family Medicine Plus LLC
city: Kyiv
country: Ukraine
facility: Kyiv Railway Station Clinical Hospital #2
city: Odessa
country: Ukraine
facility: Odeska oblasna klinichna likarnia
city: Odessa
country: Ukraine
facility: Multidisciplinary Medical Center of Odessa National Medical University
city: Poltava
country: Ukraine
facility: ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
city: Sumy
country: Ukraine
facility: Sumska oblasna klinichna likarnia
city: Ternopil
country: Ukraine
facility: Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
city: Vinnytsia
country: Ukraine
facility: Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
city: Vinnytsya
country: Ukraine
facility: Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
city: Zhytomyr
country: Ukraine
facility: Zhytomyr Central City Hospital #1
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: