Clinical trial NCT04929210: A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Arthritis, Psoriatic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-06-18
Enrollment: 405
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) axial disease by assessing reduction in axial symptoms and inflammation.

Detailed description: PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin (Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production. This study will consist of a screening phase (up to 6 weeks), a treatment phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up phase (up to Week 60). The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments will include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events. The overall duration of the study will be up to 14 months.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening
* Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
* Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac \[SI\] joints, shown by a Spondyloarthritis Research Consortium of Canada \[SPARCC\] score of \>= 3 in either the spine or the sacroiliac joints)
* Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale \[VAS\]) of at least 4
* Have active plaque psoriasis, with at least 1 psoriatic plaque of \>= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis

Exclusion Criteria:

* Has known allergies, hypersensitivity, or intolerance to guselkumab 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), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
* Has previously received any biologic treatment
* Has ever received a Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational 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: Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants with Investigator's Global Assessment (IGA) 0/1 Response at Week 24 among Participants with >= 3% Body Surface Area (BSA) Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
timeFrame: Week 24
measure: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants who Achieve a >= 50 % Improvement from Baseline in BASDAI Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants who Achieve ASDAS Clinically Important Improvement at Week 24
timeFrame: Week 24
measure: Percentage of Participants who Achieve Ankylosing Spondylitis Activity Score (ASAS) 40 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants who Achieve ASDAS Major Improvement at Week 24
timeFrame: Week 24
measure: Change from Baseline in SPARCC Score for MRI Spine at Week 24
timeFrame: Baseline and Week 24
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 60 weeks
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 60 weeks
measure: Number of Participants with Reasonably Related AEs
timeFrame: Up to 60 weeks
measure: Number of Participants with AEs Leading to Discontinuation of Study Intervention
timeFrame: Up to 60 weeks
measure: Number of Participants with Infections
timeFrame: Up to 60 weeks
measure: Number of participants with Injection-Site Reactions
timeFrame: Up to 60 weeks
measure: Number of Participants with Laboratory Abnormalities (Chemistry, Hematology) by Maximum Toxicity (Common Terminology Criteria for Adverse Events [CTCAE 5.0]) Grades
timeFrame: Up to 60 weeks
measure: Serum Guselkumab Concentration Over Time
timeFrame: Up to 60 weeks
measure: Number of Participants with Antibodies to Guselkumab
timeFrame: Up to 60 weeks
Other outcomes:
Locations:
city: Avondale
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Chandler
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis Research, PLC.
state: Arizona
city: Sun City
country: United States
facility: Arizona Arthritis and Rheumatology Associates
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Healthcare System
state: Arizona
city: Searcy
country: United States
facility: Unity Health-White County Medical Center
state: Arkansas
city: Fontana
country: United States
facility: Kaiser Permanent Medical Center
state: California
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group
state: California
city: La Jolla
country: United States
facility: University Of California San Diego
state: California
city: San Diego
country: United States
facility: Rheumatology Center of San Diego
state: California
city: Danbury
country: United States
facility: Clinical Research Center of Connecticut
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology And Immunology Specialists
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Rockford
country: United States
facility: OrthoIllinois
state: Illinois
city: Willowbrook
country: United States
facility: Willow Rheumatology and Wellness
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical
state: Maryland
city: Hagerstown
country: United States
facility: Klein And Associates M D P A
state: Maryland
city: Saint Clair Shores
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Eagan
country: United States
facility: St. Paul Rheumatology P A
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Physician Partners
state: Missouri
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: Vandalia
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Portland
country: United States
facility: OHSU Rheumatology Clinic, Marquam Hill
state: Oregon
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research
state: Texas
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Corpus Christi
country: United States
facility: Adriana Pop Moody MD Clinic PA
state: Texas
city: Fort Worth
country: United States
facility: AARA Clinical Research Lone Star Arthritis and Rheumatology
state: Texas
city: Houston
country: United States
facility: UT Physicians Center for Autoimmunity
state: Texas
city: Irving
country: United States
facility: AARA Clinical Research Lone Star Arthritis and Rheumatology
state: Texas
city: Lubbock
country: United States
facility: West Texas Clinical Research
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research LLC
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Buenos Aires
country: Argentina
facility: Cosultorios Reumatologógicos Pampa
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar
city: La Plata
country: Argentina
facility: Hospital Italiano La Plata
city: San Fernando
country: Argentina
facility: MR Medicina Reumatologica
city: San Miguel De Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
city: Camberwell
country: Australia
facility: Emeritus Research
city: Hobart
country: Australia
facility: Southern Clinical Research
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
city: Melbourne
country: Australia
facility: Skin Health Institute Inc.
city: Melbourne
country: Australia
facility: Eastern Health - Box Hill Hospital
city: Pleven
country: Bulgaria
facility: Exacta Medica
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: Medical Center Unimed Plovdiv
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela
city: Plovdiv
country: Bulgaria
facility: Medical Center Artmed
city: Sofia
country: Bulgaria
facility: MHAT 'Lyulin' EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital Sofiamed Sofia
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: UMHAT St. Ivan Rilski
city: Sofia
country: Bulgaria
facility: DCC Convex EOOD
city: Sofia
country: Bulgaria
facility: ASIMP Rheumatology Centre St Irina EOOD
city: Sofia
country: Bulgaria
facility: Medical Centre Synexus
city: Targovishte
country: Bulgaria
facility: DDC Sv. Ivan Rilski OOD
city: Vancouver
country: Canada
facility: Skin Care Centre
state: British Columbia
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: Quebec
country: Canada
facility: G R M O Groupe de recherche en maladies osseuses Inc
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: Karvina Frystat
country: Czechia
facility: Revimex Pro s r o
city: Ostrava
country: Czechia
facility: MUDr Rosypalova s r o
city: Pardubice
country: Czechia
facility: Arthrohelp S.R.O.
city: Praha
country: Czechia
facility: Revmatologicky ustav
city: Uherske Hradiste
country: Czechia
facility: Medical Plus S R O
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup
city: Køge
country: Denmark
facility: Køge Sygehus Region Sjaelland
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Batumi
country: Georgia
facility: Ltd Health Center
city: Kutaisi
country: Georgia
facility: LTD Clinic LJ
city: T'bilisi
country: Georgia
facility: Ltd American Hospital Network
city: T'bilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic Ltd
city: T'bilisi
country: Georgia
facility: LTD 'Aversi Clinic'
city: T'bilisi
country: Georgia
facility: Clinic on Mtskheta Street
city: Tbilisi
country: Georgia
facility: Aleksandre Aladashvili Clinic LLC
city: Tbilisi
country: Georgia
facility: LTD Helsicore
city: Tbilisi
country: Georgia
facility: Ltd New Hospitals
city: Tbilisi
country: Georgia
facility: TSMU The First University Clinic
city: Tbilisi
country: Georgia
facility: JSC K Eristavi National Center of experimental and Clinical surgery
city: Tbilisi
country: Georgia
facility: LTD MediClub Georgia
city: Tbilisi
country: Georgia
facility: LTD The First Medical Center
city: Tbilisi
country: Georgia
facility: Consilium Medulla-multiprofile clinic Ltd
city: Tnilisi
country: Georgia
facility: JSC Evex Hospitals
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Hamburg
country: Germany
facility: Hamburger Rheuma Forschungszentrum II
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen
city: Hong Kong
country: Hong Kong
facility: Prince Of Wales Hospital
city: Budapest
country: Hungary
facility: Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: Qualiclinic Kft
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Hodmezovasarhely
country: Hungary
facility: Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
city: Kistarcsa
country: Hungary
facility: Kistarcsai Flor Ferenc Korhaz
city: Székesfehérvár
country: Hungary
facility: Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
city: Veszprem
country: Hungary
facility: Vital Medical Center Orvosi es Fogaszati Kozpont
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Hifa
country: Israel
facility: Carmel Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Kfar-Sava
country: Israel
facility: Meir Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Ancona
country: Italy
facility: A.O. Universitaria Ospedali Riuniti di Ancona
city: Monserrato
country: Italy
facility: Azienda Ospedaliero-Universitaria di Cagliari
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova - IRCCS
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Rozzano (MI)
country: Italy
facility: Humanitas Hospital
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
city: Cebu City
country: Philippines
facility: Cebu Doctors' University Hospital
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Lipa
country: Philippines
facility: Lipa Medix Medical Hospital
city: Manila
country: Philippines
facility: ManilaMed Medical Center Manila
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: San Fernando
country: Philippines
facility: Ilocos Training and Regional Medical Center
city: Bialystok
country: Poland
facility: ClinicMed Daniluk Nowak Spolka Komandytowa
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela
city: Bytom
country: Poland
facility: Nzoz Bif Med
city: Elblag
country: Poland
facility: Ambulatorium sp. z o.o.
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze
city: Krakow
country: Poland
facility: Malopolskie Badania Kliniczne Sp z o o
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp z o o
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
city: Lodz
country: Poland
facility: Centrum Medyczne AMED oddzial w Lodzi
city: Lublin
country: Poland
facility: Velocity Lublin
city: Lublin
country: Poland
facility: Reumed Zespol Poradni Specjalistycznych Filia nr 1
city: Lublin
country: Poland
facility: Pro Life Medica Sp. z o.o.
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK MED S C
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
city: Poznan
country: Poland
facility: Twoja Przychodnia PCM
city: Poznan
country: Poland
facility: Reumedika s c Wieslawa Porawska Lukasz Porawski
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun
city: Warsaw
country: Poland
facility: MICS Centrum Medyczne Warszawa
city: Warsaw
country: Poland
facility: Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
city: Warszawa
country: Poland
facility: Rheuma Medicus Sp z o o
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park
city: Warszawa
country: Poland
facility: ETG Warszawa
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Targowek
city: Wroclaw
country: Poland
facility: WroMedica I Bielicka A Strzalkowska s c
city: Braga
country: Portugal
facility: Uls Braga - Hosp. Braga
city: Guarda
country: Portugal
facility: Ulsg - Hosp. Sousa Martins
city: Lisboa
country: Portugal
facility: Ipr Inst Port de Reumatologia
city: Lisboa
country: Portugal
facility: Uls Lisboa Ocidental - Hosp. Egas Moniz
city: Lisboa
country: Portugal
facility: Hosp. Cuf Tejo
city: Lisboa
country: Portugal
facility: Uls Santa Maria - Hosp. Santa Maria
city: Ponte de Lima
country: Portugal
facility: Ulsam - Hosp. Conde de Bertiandos
city: Porto
country: Portugal
facility: Uls Sao Joao - Hosp. Sao Joao
city: Barnaul
country: Russian Federation
facility: Altay Medical State University
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinck Regional Clinical Hospital
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Dermatovenerological Dispensary
city: Ekaterinbourg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital N. 1
city: Izhevsk
country: Russian Federation
facility: Regional Clinical Diagnostic Center of Udmurtia Region
city: Kemerovo
country: Russian Federation
facility: LLL Medical Center Revma-Med
city: Korolev
country: Russian Federation
facility: LLC Family Outpatient Clinic # 4
city: Krasnoyarsk
country: Russian Federation
facility: Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
city: Moscow
country: Russian Federation
facility: Clinical-Diagnostic Center Euromedservice, JSC
city: Moscow
country: Russian Federation
facility: FGBU Research Institute of Rheumatology named V.A.Nasonova
city: Moscow
country: Russian Federation
facility: GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
city: Omsk
country: Russian Federation
facility: Llc Ultramed
city: Orenburg
country: Russian Federation
facility: GBOU VPO Orenburg State Medical University
city: Perm
country: Russian Federation
facility: GBUZ Perm Regional Clinical Hospital
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital n.a.V.A.Baranov
city: Rostov
country: Russian Federation
facility: Rostov Regional Clinical Dermatovenerological Dispensary
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg GBUZ Clinical Reumatological Hospital 25
city: St. Petersburg
country: Russian Federation
facility: X7 Clinical Research Company Limited
city: Tolyatti
country: Russian Federation
facility: GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
city: Ufa
country: Russian Federation
facility: Republican Clinical Hospital - G.G. Kuvatov
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital #3
city: Martin
country: Slovakia
facility: Reumatologicka ambulancia
city: Nove Mesto nad Vahom
country: Slovakia
facility: Reumatologicka ambulancia
city: Piestany
country: Slovakia
facility: Reumatologická ambulancia Thermium s.r.o.
city: Poprad
country: Slovakia
facility: REUMAMED POPRAD, s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: Reumex s.r.o
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Barakaldo
country: Spain
facility: Hosp. Univ. de Cruces
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Bilbao
country: Spain
facility: Hosp. Univ. de Basurto
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Málaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Santiago de Compostela
country: Spain
facility: Clinica Gaias
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Sevilla
country: Spain
facility: Hosp. Quiron Sagrado Corazon
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Hsin Chu
country: Taiwan
facility: National Taiwan University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital and Medical College
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital Mahidol University
city: Chiangmai
country: Thailand
facility: Chiang Mai University
city: Adana
country: Turkey
facility: Adana City Hospital
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Marmara University Medical Faculty
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medical Faculty
city: Cherkasy
country: Ukraine
facility: Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
city: Kharkiv
country: Ukraine
facility: Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
city: Khmelnytsky
country: Ukraine
facility: Khmelnitckiy regional hospital
city: Kryvyi Rih
country: Ukraine
facility: City Clinical Hospital No. 2
city: Kyiv
country: Ukraine
facility: Medical Center of 'Institute of Rheumatology', LLC
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
city: Kyiv
country: Ukraine
facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
city: Lutsk
country: Ukraine
facility: Volyn Regional Clinical Hospital
city: Odessa
country: Ukraine
facility: Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
city: Poltava
country: Ukraine
facility: ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
city: Ternopil
country: Ukraine
facility: Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
city: Vinnytsia
country: Ukraine
facility: Health Clinic Limited Liability Company
city: Zaporizhzhya
country: Ukraine
facility: Medical Center LLC 'Modern Clinic'
city: Barnet
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: Bradford
country: United Kingdom
facility: St. Lukes Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry & Warwickshire NHS Trust
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: North Tyneside General Hospital
city: Stoke on Trent
country: United Kingdom
facility: Haywood Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Gladman DD, Mease PJ, Bird P, Soriano ER, Chakravarty SD, Shawi M, Xu S, Quinn ST, Gong C, Leibowitz E, Poddubnyy D, Tam LS, Helliwell PS, Kavanaugh A, Deodhar A, Ostergaard M, Baraliakos X. Efficacy and safety of guselkumab in biologic-naive patients with active axial psoriatic arthritis: study protocol for STAR, a phase 4, randomized, double-blinded, placebo-controlled trial. Trials. 2022 Sep 5;23(1):743. doi: 10.1186/s13063-022-06589-y.