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NCT05946941Active, not recruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)

Source: ClinicalTrials.gov · Last updated 1 Apr 2026

Brief summary (registry, in English)

The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
774 (actual)
First submitted
7 Jul 2023
Start date
11 Sept 2023
Primary completion date
18 Nov 2026
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT05946941
EU CT number
2023-503327-26-00
EudraCT number
2023-503327-26

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 774
  • From 11 Sept 2023 to the primary completion date, 18 Nov 2026
  • 196 sites in 33 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

  • Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered.
  • Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds.

Other illness

  • Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus \[SLE\], systemic sclerosis).
  • Medical condition associated with sicca syndrome.

Other

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS at screening (score ≥ 4), and who have disease duration (from time of initial clinical SjS diagnosis) of at least 16 weeks prior to screening.
  • Have moderate to severe SjS ESSDAI ≥ 5.
  • Short duration of disease (≤ 10 years) before screening.
  • A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute).
  • Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening.

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

Full criteria on ClinicalTrials.gov

Sites (196)

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

SiteCityCountrySite status
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CABAArgentinaUnknown status
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CABAArgentinaUnknown status
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City of Buenos AiresArgentinaUnknown status
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Ciudad Autonoma de Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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QuilmesArgentinaUnknown status
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San IsidroArgentinaUnknown status
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San Miguel de TucumánArgentinaUnknown status
Medical University of Graz
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GrazAustriaRecruiting
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Woodville SouthAustraliaUnknown status
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
University Multiprofile Hospital For Active Treatment Kaspela EOOD
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PlovdivBulgariaRecruiting
Multispecialty hospital for active treatment Sveta Sofia EOOD
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SofiyaBulgariaRecruiting
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Belo HorizonteBrazilUnknown status
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Juiz de ForaBrazilUnknown status
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Porto AlegreBrazilUnknown status
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São PauloBrazilUnknown status
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UberlândiaBrazilUnknown status
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VitóriaBrazilUnknown status
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SherbrookeCanadaUnknown status
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TorontoCanadaUnknown status
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Trois-RivièresCanadaUnknown status
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VancouverCanadaUnknown status
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BernSwitzerlandUnknown status
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Sankt GallenSwitzerlandUnknown status
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SantiagoChileUnknown status
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SantiagoChileUnknown status
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SantiagoChileUnknown status
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Santiago de ChlieChileUnknown status
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ValdiviaChileUnknown status
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Viña del MarChileUnknown status
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BeijingChinaUnknown status
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BeijingChinaUnknown status
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BeijingChinaUnknown status
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ChangshaChinaUnknown status
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ChangshaChinaUnknown status
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ChengduChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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HangzhouChinaUnknown status
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HohhotChinaUnknown status
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NanchangChinaUnknown status
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NanchangChinaUnknown status
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NanjingChinaUnknown status
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NanjingChinaUnknown status
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NingboChinaUnknown status
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PingxiangChinaUnknown status
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ShanghaiChinaUnknown status
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ShanghaiChinaUnknown status
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Shanghai ShiChinaUnknown status
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ShenzhenChinaUnknown status
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SuzhouChinaUnknown status
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TaiyuanChinaUnknown status
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ÜrümqiChinaUnknown status
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WenzhouChinaUnknown status
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WuhanChinaUnknown status
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XiamenChinaUnknown status
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Xi'anChinaUnknown status
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ZhengzhouChinaUnknown status
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BarranquillaColombiaUnknown status
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Bogota D.CColombiaUnknown status
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ChíaColombiaUnknown status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
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HamburgGermanyRecruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyRecruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Universitario De Canarias
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La LagunaSpainRecruiting
Hospital de Mérida
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MéridaSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Clínica Gaias - Santiago
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Santiago de CompostelaSpainRecruiting
Hospital Quironsalud Infanta Luisa
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SevillaSpainRecruiting
HUS-Yhtymae
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HelsinkiFinlandRecruiting
Satucon Oy
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KuopioFinlandRecruiting
Turku University Hospital
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TurkuFinlandRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Groupe Hospitalier Du Havre
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Le Havre CedexFranceRecruiting
Bicetre Hospital
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Le Kremlin Bicetre CedexFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
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BirminghamUnited KingdomUnknown status
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CannockUnited KingdomUnknown status
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SouthamptonUnited KingdomUnknown status
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WolverhamptonUnited KingdomUnknown status
Laiko General Hospital of Athens
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AthensGreeceRecruiting
General University Hospital of Larissa
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LarissaGreeceRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
Bekes Varmegyei Koezponti Korhaz
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GyulaHungaryRecruiting
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Kfar SabaIsraelUnknown status
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Ramat GanIsraelUnknown status
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Fondazione Policlinico Universitario Campus Bio-Medico
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RomeItalyRecruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyRecruiting
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Bunkyo-kuJapanUnknown status
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Bunkyo-kuJapanUnknown status
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Chuo-kuJapanUnknown status
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HamamatsuJapanUnknown status
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Kahoku-gunJapanUnknown status
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KanazawaJapanUnknown status
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Kawasaki-shiJapanUnknown status
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Kitakyushu-shiJapanUnknown status
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KurashikiJapanUnknown status
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Meguro-kuJapanUnknown status
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Meguro-kuJapanUnknown status
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NagasakiJapanUnknown status
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NagoyaJapanUnknown status
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Nishinomiya-shiJapanUnknown status
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ŌtsuJapanUnknown status
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SapporoJapanUnknown status
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SapporoJapanUnknown status
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SaseboJapanUnknown status
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SendaiJapanUnknown status
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ShimotsugagunJapanUnknown status
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Shinagawa-kuJapanUnknown status
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ShinjukuJapanUnknown status
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tabashi CityJapanUnknown status
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Toyoake-shiJapanUnknown status
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TsukubaJapanUnknown status
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YokohamaJapanUnknown status
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GwangjuSouth KoreaUnknown status
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Seongdong-guSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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GuadalajaraMexicoUnknown status
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GuadalajaraMexicoUnknown status
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LeónMexicoUnknown status
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Mexico CityMexicoUnknown status
Universitair Medisch Centrum Groningen
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GroningenNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
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Jesus MariaPeruUnknown status
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LimaPeruUnknown status
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Santiago de SurcoPeruUnknown status
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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BydgoszczPolandRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
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BydgoszczPolandRecruiting
Centrum Medyczne Plejady Sp. z o.o. S.K.
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CracowPolandRecruiting
Pro Life Medica Sp. z o.o.
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LublinPolandRecruiting
Med Polonia Sp z o.o.
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PoznanPolandRecruiting
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
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WarsawPolandRecruiting
Rheuma Medicus Sp z o o
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WarsawPolandRecruiting
Klinika Reuma Park Sp. z o.o. S.K.
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WarsawPolandRecruiting
Futuremeds Sp. z o.o.
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WarsawPolandRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
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WarsawPolandRecruiting
Dolnośląski Szpital Specjalistyczny im. T. Marciniaka - Centrum Medycyny Ratunkowej
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WroclawPolandRecruiting
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o
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WroclawPolandRecruiting
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San JuanPuerto RicoUnknown status
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San JuanPuerto RicoUnknown status
Instituto Portugues de Reumatologia
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LisbonPortugalRecruiting
Hospital De Santa Maria E.P.E.
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LisbonPortugalRecruiting
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
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BrasovRomaniaRecruiting
Arensia Clinics S.R.L.
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BucharestRomaniaRecruiting
Spitalul Clinic Judetean De Urgenta Cluj
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Cluj-NapocaRomaniaRecruiting
Sahlgrenska University Hospital-Vastra Gotalandsregionen
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GoteborgSwedenRecruiting
Region Stockholm – SLSO
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StockholmSwedenRecruiting
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Kaohsiung CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TaichungTaiwanUnknown status
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TaipeiTaiwanUnknown status
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Taoyuan CityTaiwanUnknown status
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AlbuquerqueUnited StatesUnknown status
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AllenUnited StatesUnknown status
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AugustaUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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Baton RougeUnited StatesUnknown status
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BostonUnited StatesUnknown status
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ClearwaterUnited StatesUnknown status
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Cooper CityUnited StatesUnknown status
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DenverUnited StatesUnknown status
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DuncansvilleUnited StatesUnknown status
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EaganUnited StatesUnknown status
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FullertonUnited StatesUnknown status
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JacksonUnited StatesUnknown status
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Kansas CityUnited StatesUnknown status
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KatyUnited StatesUnknown status
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La PalmaUnited StatesUnknown status
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LawrencevilleUnited StatesUnknown status
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MineolaUnited StatesUnknown status
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MonroeUnited StatesUnknown status
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PlanoUnited StatesUnknown status
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SalisburyUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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Santa MonicaUnited StatesUnknown status
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SarasotaUnited StatesUnknown status
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SeattleUnited StatesUnknown status
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SkokieUnited StatesUnknown status
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SpokaneUnited StatesUnknown status
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SummitUnited StatesUnknown status
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AnkaraTurkey (Türkiye)Unknown status
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AntalyaTurkey (Türkiye)Unknown status
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IstanbulTurkey (Türkiye)Unknown status
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YenimahalleTurkey (Türkiye)Unknown status

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