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NCT04929210Active, not recruitingPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
411 (actual)
First submitted
11 Jun 2021
Start date
30 Aug 2021
Primary completion date
1 Apr 2027
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04929210
EU CT number
2023-504716-15-00
EudraCT number
2021-000465-32

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 411
  • From 30 Aug 2021 to the primary completion date, 1 Apr 2027
  • 222 sites in 26 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (222)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cosultorios Reumatologógicos Pampa
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Buenos AiresArgentinaUnknown status
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaUnknown status
Centro Privado de Medicina Familiar
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Buenos AiresArgentinaUnknown status
Hospital Italiano La Plata
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La PlataArgentinaUnknown status
MR Medicina Reumatologica
Coordinator of this site? Confirm its status
San FernandoArgentinaUnknown status
Centro Medico Privado de Reumatologia
Coordinator of this site? Confirm its status
San Miguel de TucumánArgentinaUnknown status
Emeritus Research
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CamberwellAustraliaUnknown status
Southern Clinical Research
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HobartAustraliaUnknown status
Liverpool Hospital
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LiverpoolAustraliaUnknown status
Rheumatology Research Unit
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MaroochydoreAustraliaUnknown status
Skin Health Institute Inc.
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MelbourneAustraliaUnknown status
Eastern Health - Box Hill Hospital
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MelbourneAustraliaUnknown status
Medical Center Exacta Medica OOD
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PlevenBulgariaActive, not recruiting
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
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PlevenBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment Kaspela EOOD
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PlovdivBulgariaActive, not recruiting
Medical center "Artmed" LTD
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PlovdivBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
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SofiaBulgariaActive, not recruiting
Mbal Lyulin EAD
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SofiyaBulgariaActive, not recruiting
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
Eastern Regional Health Authority St Clares Mercy Hospital
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St. John'sCanadaUnknown status
Toronto Western Hospital
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TorontoCanadaUnknown status
Skin Care Centre
Coordinator of this site? Confirm its status
VancouverCanadaUnknown status
Revmacentrum MUDr Mostera s r o
Coordinator of this site? Confirm its status
Brno-ŽideniceCzechiaActive, not recruiting
L.K.N. Arthrocentrum, s.r.o.
Coordinator of this site? Confirm its status
HlučínCzechiaActive, not recruiting
Revimex pro s.r.o.
Coordinator of this site? Confirm its status
KarvinaCzechiaActive, not recruiting
MUDr. Rosypalova s.r.o.
Coordinator of this site? Confirm its status
PorubaCzechiaActive, not recruiting
Revmatologicky Ustav
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Prague 2CzechiaActive, not recruiting
MEDICAL PLUS s.r.o.
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Uherské HradištěCzechiaActive, not recruiting
ISA - Interdisciplinary Study Association GmbH
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BerlinGermanyCompleted
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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HerneGermanyCompleted
Frederiksberg Hospital
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FrederiksbergDenmarkCompleted
Region Sjaelland
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KoegeDenmarkCompleted
Lillebaelt Hospital
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VejleDenmarkCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital Universitario de Cruces
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BarakaldoSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitario Basurto
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BilbaoSpainActive, not recruiting
Hospital General Universitario Reina Sofia
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CórdobaSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Parc Tauli Hospital Universitari
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SabadellSpainActive, not recruiting
Clínica Gaias - Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Quironsalud Sagrado Corazon
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SevillaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Royal Free London NHS Foundation Trust
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BarnetUnited KingdomUnknown status
St. Lukes Hospital
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BradfordUnited KingdomUnknown status
University Hospital Coventry & Warwickshire NHS Trust
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CoventryUnited KingdomUnknown status
Chapel Allerton Hospital
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LeedsUnited KingdomUnknown status
Central Manchester University Hospitals Nhs Foundation Trust
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ManchesterUnited KingdomUnknown status
North Tyneside General Hospital
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NewcastleUnited KingdomUnknown status
Haywood Hospital
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Stoke-on-TrentUnited KingdomUnknown status
Ltd Health Center
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BatumiGeorgiaUnknown status
LTD Clinic LJ
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KutaisiGeorgiaUnknown status
LTD "New Hospitals"
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TbilisiGeorgiaUnknown status
Tbilisi Heart and Vascular Clinic LTD
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TbilisiGeorgiaUnknown status
LTD MediClub Georgia
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TbilisiGeorgiaUnknown status
JSC K. Eristavi National Center of Experimental and Clinical Surgery
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TbilisiGeorgiaUnknown status
Ltd American Hospital Network
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TbilisiGeorgiaUnknown status
LTD The First Medical Center
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TbilisiGeorgiaUnknown status
TSMU The First University Clinic
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TbilisiGeorgiaUnknown status
Clinic on Mtskheta Street
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TbilisiGeorgiaUnknown status
LTD Aversi Clinic
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TbilisiGeorgiaUnknown status
LTD Helsicore
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TbilisiGeorgiaUnknown status
Consilium Medulla-multiprofile clinic Ltd
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TbilisiGeorgiaUnknown status
Aleksandre Aladashvili Clinic LLC
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TbilisiGeorgiaUnknown status
JSC Evex Hospitals
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TnilisiGeorgiaUnknown status
Prince of Wales Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Qualiclinic Kft.
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BudapestHungaryCompleted
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
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Budapest IIHungaryCompleted
Obudai Egeszseguegyi Centrum Kft.
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Budapest IIIHungaryCompleted
Bekes Varmegyei Koezponti Korhaz
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GyulaHungaryCompleted
Vasarhelyi Sarkanyfu Kft.
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HódmezővásárhelyHungaryCompleted
Kistarcsai Flor Ferenc Korhaz
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KistarcsaHungaryCompleted
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
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SzekesfehervarHungaryCompleted
Vital-Medicina Kft.
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VeszpremHungaryCompleted
Bnai Zion Medical Center
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HaifaIsraelUnknown status
Carmel Medical Center
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HaifaIsraelUnknown status
Wolfson Medical Center
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HolonIsraelUnknown status
Meir Medical Center
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Kfar SabaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyCompleted
Azienda Ospedaliero - Universitaria di Cagliari
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CagliariItalyCompleted
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyCompleted
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyCompleted
Humanitas Research Hospital
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RozzanoItalyCompleted
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyCompleted
Hospital Selayang
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Batu CavesMalaysiaUnknown status
Hospital Pulau Pinang
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George TownMalaysiaUnknown status
Hospital Sultan Ismail
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Johor BahruMalaysiaUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Hospital Tuanku Jaafar
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SerembanMalaysiaUnknown status
Cebu Doctors University Hospital
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Cebu CityPhilippinesUnknown status
Davao Doctors Hospital
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Davao CityPhilippinesUnknown status
Lipa Medix Medical Hospital
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LipaPhilippinesUnknown status
Philippine General Hospital
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ManilaPhilippinesUnknown status
ManilaMed Medical Center Manila
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ManilaPhilippinesUnknown status
St. Luke's Medical Center
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Quezon CityPhilippinesUnknown status
Ilocos Training and Regional Medical Center
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San Fernando CityPhilippinesUnknown status
Clinicmed Daniluk Nowak Sp. k.
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BialystokPolandActive, not recruiting
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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BydgoszczPolandActive, not recruiting
Niepubliczny Zaklad Opieki Zdrowotnej Bif Med
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BytomPolandActive, not recruiting
Malopolskie Badania Kliniczne Sp. z o.o.
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CracowPolandActive, not recruiting
Ambulatorium Sp. z o.o.
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ElblagPolandActive, not recruiting
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandActive, not recruiting
Futuremeds Sp. z o.o.
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LodzPolandActive, not recruiting
DERMED Centrum Medyczne Sp. z o.o.
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LodzPolandActive, not recruiting
Reumed Sp. z o.o.
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LublinPolandActive, not recruiting
Pro Life Medica Sp. z o.o.
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LublinPolandActive, not recruiting
Velocity Nova Sp. z o.o.
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LublinPolandActive, not recruiting
NZOZ Lecznica MAK MED S C
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NadarzynPolandActive, not recruiting
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
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Nowa SolPolandActive, not recruiting
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
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PoznanPolandActive, not recruiting
Reumedika Sp. z o.o.
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PoznanPolandActive, not recruiting
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
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ŚwidnikPolandActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandActive, not recruiting
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
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WarsawPolandActive, not recruiting
Centrum Medyczne Amed Sp. z o.o.
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WarsawPolandActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
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WarsawPolandActive, not recruiting
Klinika Reuma Park Sp. z o.o. S.K.
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WarsawPolandActive, not recruiting
Rheuma Medicus Sp z o o
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WarsawPolandActive, not recruiting
WroMedica I Bielicka A Strzalkowska s c
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WroclawPolandActive, not recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalCompleted
Unidade Local De Saude Da Guarda E.P.E.
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GuardaPortugalCompleted
Instituto Portugues de Reumatologia
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LisbonPortugalCompleted
Unidade Local De Saude De Lisboa Ocidental E.P.E.
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LisbonPortugalCompleted
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalCompleted
Unidade Local De Saude Do Alto Minho E.P.E.
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Ponte De LimaPortugalCompleted
Unidade Local de Saude de Sao Joao E.P.E.
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PortoPortugalCompleted
Altay Medical State University
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BarnaulRussiaUnknown status
Chelyabinck Regional Clinical Hospital
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ChelyabinskRussiaUnknown status
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
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ChelyabinskRussiaUnknown status
Regional Clinical Diagnostic Center of Udmurtia Region
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IzhevskRussiaUnknown status
LLL Medical Center Revma-Med
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KemerovoRussiaUnknown status
LLC Family Outpatient Clinic # 4
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KorolyovRussiaUnknown status
Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
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KrasnoyarskRussiaUnknown status
Clinical-Diagnostic Center Euromedservice, JSC
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MoscowRussiaUnknown status
FGBU Research Institute of Rheumatology named V.A.Nasonova
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MoscowRussiaUnknown status
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
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MoscowRussiaUnknown status
Llc Ultramed
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OmskRussiaUnknown status
GBOU VPO Orenburg State Medical University
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OrenburgRussiaUnknown status
GBUZ Perm Regional Clinical Hospital
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PermRussiaUnknown status
Republican Hospital n.a.V.A.Baranov
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PetrozavodskRussiaUnknown status
Rostov Regional Clinical Dermatovenerological Dispensary
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Rostov-on-DonRussiaUnknown status
St. Petersburg GBUZ Clinical Reumatological Hospital 25
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Saint PetersburgRussiaUnknown status
X7 Clinical Research Company Limited
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Saint PetersburgRussiaUnknown status
GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
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TolyattiRussiaUnknown status
Republican Clinical Hospital - G.G. Kuvatov
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UfaRussiaUnknown status
Clinical Hospital #3
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YaroslavlRussiaUnknown status
Sverdlovsk Regional Clinical Hospital N. 1
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YekaterinburgRussiaUnknown status
Karolinska University Hospital
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SolnaSwedenCompleted
Uppsala University Hospital
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UppsalaSwedenCompleted
MEDMAN s.r.o.
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MartinSlovakiaActive, not recruiting
Reum.hapi s.r.o.
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Nove Mesto Nad VahomSlovakiaActive, not recruiting
Thermium s.r.o.
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PiestanySlovakiaActive, not recruiting
REUMAMED POPRAD, s.r.o.
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PopradSlovakiaActive, not recruiting
Reumex S.R.O.
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Rimavská SobotaSlovakiaActive, not recruiting
Phramongkutklao Hospital and Medical College
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BangkokThailandUnknown status
Ramathibodi Hospital, Mahidol University
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BangkokThailandUnknown status
Chiang Mai University
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Chiang MaiThailandUnknown status
National Taiwan University Hospital
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HsinchuTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
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CherkasyUkraineUnknown status
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
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KharkivUkraineUnknown status
Khmelnitckiy regional hospital
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KhmelnytskyUkraineUnknown status
City Clinical Hospital No. 2
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Kryvyi RihUkraineUnknown status
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
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KyivUkraineUnknown status
Medical Center of 'Institute of Rheumatology', LLC
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KyivUkraineUnknown status
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
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KyivUkraineUnknown status
Volyn Regional Clinical Hospital
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LutskUkraineUnknown status
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
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OdesaUkraineUnknown status
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
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PoltavaUkraineUnknown status
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
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TernopilUkraineUnknown status
Health Clinic Limited Liability Company
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VinnytsiaUkraineUnknown status
Medical Center LLC 'Modern Clinic'
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ZaporizhzhyaUkraineUnknown status
Amarillo Center For Clinical Research
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AmarilloUnited StatesUnknown status
Austin Regional Clinic
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AustinUnited StatesUnknown status
Arizona Arthritis and Rheumatology Research PLLC 1
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AvondaleUnited StatesUnknown status
Johns Hopkins Bayview Medical
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BaltimoreUnited StatesUnknown status
Bay Pines VA Healthcare System
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Bay PinesUnited StatesUnknown status
Arizona Arthritis & Rheumatology Research, PLLC
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ChandlerUnited StatesUnknown status
Great Lakes Clinical Trials
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ChicagoUnited StatesUnknown status
Precision Comprehensive Clinical Research Solutions
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ColleyvilleUnited StatesUnknown status
Adriana Pop-Moody MD Clinic PA
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Corpus ChristiUnited StatesUnknown status
Clinical Research Center of Connecticut
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DanburyUnited StatesUnknown status
St. Paul Rheumatology P A
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EaganUnited StatesUnknown status
Kaiser Permanent Medical Center
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FontanaUnited StatesUnknown status
AARA Clinical Research Lone Star Arthritis and Rheumatology 1
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Fort WorthUnited StatesUnknown status
Klein and Associates, M.D., P.A.
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HagerstownUnited StatesUnknown status
UT Physicians Center for Autoimmunity
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HoustonUnited StatesUnknown status
Newport Huntington Medical Group
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Huntington BeachUnited StatesUnknown status
AARA Clinical Research Lone Star Arthritis and Rheumatology
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IrvingUnited StatesUnknown status
Kansas City Physician Partners
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Kansas CityUnited StatesUnknown status
University of California San Diego
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La JollaUnited StatesUnknown status
West Texas Clinical Research
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LubbockUnited StatesUnknown status
Arizona Arthritis and Rheumatology Research PLLC
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MesaUnited StatesUnknown status
SouthWest Rheumatology Research, LLC
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MesquiteUnited StatesUnknown status
Arizona Arthritis Research, PLC.
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PhoenixUnited StatesUnknown status
Integral Rheumatology And Immunology Specialists
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PlantationUnited StatesUnknown status
OHSU Rheumatology Clinic, Marquam Hill
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PortlandUnited StatesUnknown status
Epic Medical Research
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Red OakUnited StatesUnknown status
OrthoIllinois
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RockfordUnited StatesUnknown status
Clinical Research Institute of Michigan, LLC
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Saint Clair ShoresUnited StatesUnknown status
Rheumatology Center of San Diego
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San DiegoUnited StatesUnknown status
Unity Health-White County Medical Center
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SearcyUnited StatesUnknown status
Swedish Medical Center
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SeattleUnited StatesUnknown status
Clinvest
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SpringfieldUnited StatesUnknown status
Arizona Arthritis and Rheumatology Associates
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Sun CityUnited StatesUnknown status
DM Clinical Research
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TomballUnited StatesUnknown status
Southern Arizona VA Healthcare System
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TucsonUnited StatesUnknown status
STAT Research, Inc.
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VandaliaUnited StatesUnknown status
Willow Rheumatology and Wellness
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WillowbrookUnited StatesUnknown status
Florida Medical Clinic, P.A.
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ZephyrhillsUnited StatesUnknown status
Adana City Hospital
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AdanaTurkey (Türkiye)Unknown status
Gulhane Training and Research Hospital
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AnkaraTurkey (Türkiye)Unknown status
Hacettepe University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent City Hospital
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AnkaraTurkey (Türkiye)Unknown status
Akdeniz University Medical Faculty
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AntalyaTurkey (Türkiye)Unknown status
Uludag University Medical Faculty
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BursaTurkey (Türkiye)Unknown status
Marmara University Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Istanbul University Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Necmettin Erbakan University Meram Medical Faculty
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KonyaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.