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NCT06104124CompletedPhase 3

A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity. Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS. 2. To evaluate the safety and tolerability of dazodalibep in participants with SS

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
651 (actual)
First submitted
23 Oct 2023
Start date
24 Jan 2024
Primary completion date
23 Jul 2026
Lead sponsor
Amgen
NCT number
NCT06104124
EU CT number
2023-503904-10-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 651
  • From 24 Jan 2024 to the primary completion date, 23 Jul 2026
  • 226 sites in 28 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

  • Individuals with a history of more than one episode of herpes zoster and/or any opportunistic infection in the last 12 months, and active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
  • Individuals who have received a live (attenuated) vaccine within the 4 weeks prior to randomization or plan to receive a live vaccine during their participation in the study.
  • Last administration of experimental or investigational biologic or oral agents \< 6 months prior to screening.
  • Individuals who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, ofatumumab, or ianalumab) within 12 months or other B-cell-targeting therapy (eg, belimumab) \< 3 months prior to screening.

Other illness

  • Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
  • Active malignancy or history of malignancy within the last 5 years, except in situ carcinoma of cervix treated with apparent success with curative therapy \> 12 months prior to screening OR cutaneous basal cell carcinoma following presumed curative therapy.
  • Individuals with any severe or life-threatening cardiovascular (including vasculitis), respiratory, endocrine, gastrointestinal, hematological, psychiatric, or systemic disorder or any other condition that would place the individual at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of participant safety or study results.

Lab values

  • Individuals who have a positive test for hepatitis B, hepatitis C, or HIV infection. A positive test for hepatitis B at screening is defined as: (1) positive for HBsAg OR (2) positive for either HBcAb or HBsAb and HBV DNA detected above the LLOQ by reflex testing by the central laboratory at screening.

Other

  • Active TB or untreated (per local guidelines) latent TB

Who the study is looking for

  • Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.
  • Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of \>= 5 despite symptomatic or local therapy at screening.
  • Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).

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

Full criteria on ClinicalTrials.gov

Sites (226)

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

SiteCityCountrySite status
DOM Centro de Reumatología
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Buenos AiresArgentinaUnknown status
Hospital General de Agudos Dr. José María Ramos Mejia
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Buenos AiresArgentinaUnknown status
Centro Privado de Medicina Familiar
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Buenos AiresArgentinaUnknown status
Aprillus Asistencia e Investigacion de Arcis Salud SRL
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Buenos AiresArgentinaUnknown status
Centro Médico Arsema
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Buenos AiresArgentinaUnknown status
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
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Buenos AiresArgentinaUnknown status
Expertia S.A- Mautalén Salud e Investigación
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Buenos AiresArgentinaUnknown status
Sanatorio Agote - Swiss Medical Group - PPDS
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Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Sanatorio Allende S.A.
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CórdobaArgentinaUnknown status
Framingham Centro Medico
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La PlataArgentinaUnknown status
Instituto CER S.A.
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QuilmesArgentinaUnknown status
Instituto de Investigaciones Clinicas Quilmes SRL
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QuilmesArgentinaUnknown status
MR Medicina Reumatologica
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San FernandoArgentinaUnknown status
Centro Polivalente de Asistencia E Investigacion Clinica Cer San Juan
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San JuanArgentinaUnknown status
Centro de Investigaciones Reumatológicas
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San Miguel de TucumánArgentinaUnknown status
Clinica Mayo de U.M.C.B. S.R.L
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San Miguel de TucumánArgentinaUnknown status
Centro de Investigaciones Médicas Tucumán - PPDS
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San Miguel de TucumánArgentinaUnknown status
The Queen Elizabeth Hospital
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Woodville SouthAustraliaUnknown status
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS
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Belo HorizonteBrazilUnknown status
AES - AS - L2IP - Instituto de Pesquisas Clínicas LTDA Brasilia
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BrasíliaBrazilUnknown status
Centro de Estudos em Terapias Inovadoras
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CuritibaBrazilUnknown status
LMK Servicos Medicos SS
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Porto AlegreBrazilUnknown status
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
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SalvadorBrazilUnknown status
Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille
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Trois-RivièresCanadaUnknown status
Enroll SpA - Dr. Manuel Barros Borgono - PPDS
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ProvidenciaChileUnknown status
Biocinetic Ltda
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SantiagoChileUnknown status
Centro de especialidades médicas Vanguardia
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TemucoChileUnknown status
Clinical Research Chile SpA - PPDS
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ValdiviaChileUnknown status
Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas
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Viña del MarChileUnknown status
BIOMEDRO Biomedizinische Forschung und Entwicklung GmbH
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Bad DoberanGermanyCompleted
Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus Sachsen GmbH
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ChemnitzGermanyCompleted
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyCompleted
Rheumazentrum Greifswald
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GreifswaldGermanyCompleted
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
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HamburgGermanyCompleted
University Medical Center Hamburg-Eppendorf
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HamburgGermanyCompleted
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyCompleted
Klinikverbund St. Antonius und St. Josef GmbH
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WuppertalGermanyCompleted
Odense University Hospital
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Odense CDenmarkCompleted
Lillebaelt Hospital
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VejleDenmarkCompleted
Hospital Universitario Basurto
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BilbaoSpainCompleted
Hospital Universitario Reina Sofia
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CórdobaSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Infanta Leonor
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Regional de Málaga
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MálagaSpainCompleted
Parc Tauli Hospital Universitari
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SabadellSpainCompleted
University Hospital Of Canary Islands
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San Cristobal De La LagunaSpainCompleted
Fundacio Hospital de l'Esperit Sant
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Santa Coloma de GramenetSpainCompleted
Hospital Universitario Hospiten Rambla de Tenerife
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Santa Cruz de TenerifeSpainCompleted
Hospital Quironsalud Infanta Luisa
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SevillaSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Hospital Universitario Virgen De Valme
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SevillaSpainCompleted
Hospital Universitario Araba
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VitoriaSpainCompleted
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceCompleted
Centre Hospitalier Regional Et Universitaire De Brest
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Brest Cedex 2FranceCompleted
Bicetre Hospital
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Le Kremlin Bicetre CedexFranceCompleted
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
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MulhouseFranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceCompleted
Chapel Allerton Hospital - PPDS
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LeedsUnited KingdomUnknown status
William Harvey Research Institute - PPDS
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LondonUnited KingdomUnknown status
Royal Victoria Infirmary
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Newcastle upon TyneUnited KingdomUnknown status
Queen Alexandra Hospital
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PortsmouthUnited KingdomUnknown status
Laiko General Hospital of Athens
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AthensGreeceCompleted
Athens Naval Hospital
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AthensGreeceCompleted
General University Hospital of Larissa
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LarissaGreeceCompleted
Olympion Therapeftirio General Clinic Of Patras S.A.
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PatraGreeceCompleted
Euromedica Kyanous Stavros
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ThessalonikiGreeceCompleted
Poliklinika BONIFARM
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Grad ZagrebCroatiaCompleted
KBC Zagreb
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Grad ZagrebCroatiaCompleted
Klinički bolnički centar Osijek
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OsijekCroatiaCompleted
KBC Split
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SplitCroatiaCompleted
University Hospital Sveti Duh
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ZagrebCroatiaCompleted
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
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Budapest IXHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Bekes Varmegyei Koezponti Korhaz
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GyulaHungaryCompleted
Vasarhelyi Sarkanyfu Kft.
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HódmezővásárhelyHungaryCompleted
Meir Medical Center
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Kfar SabaIsraelUnknown status
The Chaim Sheba Medical Center - PPDS
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Ramat GanIsraelUnknown status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyCompleted
Azienda Sanitaria Locale Roma 4
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CivitavecchiaItalyCompleted
Careggi University Hospital
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FlorenceItalyCompleted
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
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MilanItalyCompleted
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyCompleted
Azienda Ospedaliero Universitaria Pisana
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PisaItalyCompleted
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyCompleted
Fondazione Policlinico Universitario Campus Bio-Medico
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RomeItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyCompleted
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyCompleted
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyCompleted
Nippon Medical School Hospital
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Bunkyo-kuJapanUnknown status
St. Luke's International Hospital
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Chuo-kuJapanUnknown status
Hamamatsu University Hospital
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HamamatsuJapanUnknown status
Saitama Medical University Hospital
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Iruma-gunJapanUnknown status
Kanazawa Medical University Hospital
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KahokuJapanUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
Hospital of the University of Occupational and Environmental Health, Japan
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Kita Kyushu-shiJapanUnknown status
Kurashiki Medical Clinic
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Kurashiki-ShiJapanUnknown status
Kyoto University Hospital
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KyotoJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
Tokyo Medical Center
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Meguro-KuJapanUnknown status
Nagasaki University Hospital
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NagasakiJapanUnknown status
Japan Community Health Care Organization (JCHO) Chukyo Hospital
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NagoyaJapanUnknown status
Chubu Rosai Hospital
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NagoyaJapanUnknown status
Daido Clinic
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NagoyaJapanUnknown status
Hyogo Medical University Hospital
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Nishinomiya-shiJapanUnknown status
Hokkaido University Hospital
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SapporoJapanUnknown status
Sapporo Medical University Hospital
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SapporoJapanUnknown status
Sasebo Chuo Hospital
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Sasebo-ShiJapanUnknown status
Keio University Hospital
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Shinjuku-kuJapanUnknown status
Nihon University Itabashi Hospital
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tabashi CityJapanUnknown status
University of Tsukuba Hospital
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TsukubaJapanUnknown status
National Hospital Organization Yokohama Medical Center
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YokohamaJapanUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS
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GuadalajaraMexicoUnknown status
Centro de Estudios de Investigacion Basica Y Clinica SC
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GuadalajaraMexicoUnknown status
Centro de Investigacion Farmacologica Del Bajio Sc
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LeónMexicoUnknown status
Unidad de Atencion Medica e Investigacion en Salud
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MéridaMexicoUnknown status
Centro de Investigación en Artritis y Osteoporosis - PPDS
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MexicaliMexicoUnknown status
Consultorio de Reumatologia
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MéxicoMexicoUnknown status
Clinstile, S.A. de C.V.
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MéxicoMexicoUnknown status
Cryptex Investigación Clínica, S.A. de C.V.
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Mexico CityMexicoUnknown status
Hospital Universitario Dr. Jose Eleuterio González
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MonterreyMexicoUnknown status
Oaxaca Site Management Organization - Clinic - OSMO - PPDS
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Oaxaca CityMexicoUnknown status
Mediadvance Clinical S.A.P.I. de C.V.
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Parques de San FelipeMexicoUnknown status
ONCOR - Centro de Infusion e Investigación Oncologia de Saltillo S.C
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SaltilloMexicoUnknown status
Centro de Investigación y Tratamiento Reumatológico S.C
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San Miguel ChapultepecMexicoUnknown status
CIMAB SA de CV
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Torreón CentroMexicoUnknown status
Aotearoa Clinical Trials Trust
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AucklandNew ZealandUnknown status
Optimal Clinical Trials Ltd - PPDS
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AucklandNew ZealandUnknown status
Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital)
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HamiltonNew ZealandUnknown status
Hogar Clinica San Juan de Dios - Arequipa
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ArequipaPeruUnknown status
Hospital Militar Central Luis Arias Schereiber
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LimaPeruUnknown status
Instituto de Ginecologia y Reproduccion - PPDS
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LimaPeruUnknown status
Clínica Internacional San Borja-Avenida Guardia Civil 385
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LimaPeruUnknown status
Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada
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Pueblo LibrePeruUnknown status
Clinica San Juan Bautista
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San Juan de LuriganchoPeruUnknown status
Clinica San Antonio S.A.C
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TrujilloPeruUnknown status
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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BydgoszczPolandCompleted
MICS Centrum Medyczne Bydgoszcz
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BydgoszczPolandCompleted
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
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CracowPolandCompleted
Krakowskie Centrum Medyczne Sp. z o.o.
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CracowPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandCompleted
Promed P.Lach R.Glowacki Sp. j.
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CracowPolandCompleted
Malopolskie Centrum Kliniczne
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CracowPolandCompleted
Centrum Medyczne Pratia Katowice
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KatowicePolandCompleted
Futureme ds Łódź
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ŁódźPolandCompleted
ETG Lublin
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LublinPolandCompleted
Reumed Sp. z o.o.
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LublinPolandCompleted
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o. o
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MalborkPolandCompleted
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
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Nowa SolPolandCompleted
Med Polonia Sp z o.o.
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PoznanPolandCompleted
Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj
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PoznanPolandCompleted
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
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PoznanPolandCompleted
Pratia S.A.
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SkorzewoPolandCompleted
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
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WarsawPolandCompleted
MTZ Clinical Research powered by Pratia
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WarsawPolandCompleted
Futuremeds Sp. z o.o.
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WarsawPolandCompleted
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
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WarsawPolandCompleted
Etg Warszawa Sp. z o.o.
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WarsawPolandCompleted
MICS Centrum Medyczne Warszawa
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WarszawaPolandCompleted
FutureMeds Warszawa Centrum
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WarszawaPolandCompleted
Centrum Medyczne Reuma Park
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WarszawaPolandCompleted
Centrum Medyczne K2J2
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WołominPolandCompleted
Dolnośląski Szpital Specjalistyczny im. T. Marciniaka - Centrum Medycyny Ratunkowej
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WroclawPolandCompleted
Centrum Medyczne Oporow
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WroclawPolandCompleted
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandCompleted
FutureMeds Wrocław
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WrocławPolandCompleted
PRACOWNIA BADAŃ KLINICZNYCH SALUS
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WrocławPolandCompleted
GCM Medical Group, PSC -62 Calle Jose Marti
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San JuanPuerto RicoUnknown status
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalCompleted
Unidade Local De Saude De Lisboa Ocidental 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 Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalCompleted
Military Medical Academy
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BelgradeSerbiaUnknown status
Institute of Rheumatology - PPDS
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BelgradeSerbiaUnknown status
University Clinical Center of Serbia - Pasterova 2 - PPDS
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BelgradeSerbiaUnknown status
University Clinical Center Kragujevac
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KragujevacSerbiaUnknown status
Special Hospital For Rheumatic Diseases Novi Sad
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Novi SadSerbiaUnknown status
Clinical Centre of Vojvodina
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Novi SadSerbiaUnknown status
University Medical Center Ljubljana
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LjubljanaSloveniaCompleted
Univerzitetni klinični center Maribor
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MariborSloveniaCompleted
Chang Gung Memorial Hospital, Linkou
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Gui Shan QuTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
Taipei Medical University Hospital - PPDS
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TaipeiTaiwanUnknown status
Amarillo Center For Clinical Research
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AmarilloUnited StatesUnknown status
Augusta University Medical Center-Augusta-1120 15th St
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AugustaUnited StatesUnknown status
Tekton Research, LLC - W Gate Blvd - Austin - PPDS
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AustinUnited StatesUnknown status
Arizona Arthritis & Rheumatology Associates - Avondale
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AvondaleUnited StatesUnknown status
Accurate Clinical Management-Baytown
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BaytownUnited StatesUnknown status
Rheumatology and Pulmonary Clinic
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BeckleyUnited StatesUnknown status
Overlake Arthritis & Osteoporosis Center
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BellevueUnited StatesUnknown status
Massachusetts General Hospital (MGH) - Rheumatology Associates
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BostonUnited StatesUnknown status
Bradenton Research Center, Inc.
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BradentonUnited StatesUnknown status
NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center
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BrooklynUnited StatesUnknown status
Arizona Research Clinic PLLC
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ChandlerUnited StatesUnknown status
Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 801 E Morehead St
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CharlotteUnited StatesUnknown status
Clinical Research of West Florida, Inc. (Clearwater)
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ClearwaterUnited StatesUnknown status
Duke Early Phase Clinical Research Unit - PPDS
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DurhamUnited StatesUnknown status
Cedar Health Research - Arlington - PPDS
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EulessUnited StatesUnknown status
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
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FlagstaffUnited StatesUnknown status
Tekton Research, LLC - 2121 E Harmony Rd - PPDS
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Fort CollinsUnited StatesUnknown status
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
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GilbertUnited StatesUnknown status
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
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GlendaleUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
Kansas City Physician Partners-8350 N Saint Clair Ave
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Kansas CityUnited StatesUnknown status
R & H Clinical Research - Katy - 1531 Westborough Dr
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KatyUnited StatesUnknown status
UCSD Altman Clinical and Translational Research Institute Building
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La JollaUnited StatesUnknown status
Valley Arthritis Center
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McAllenUnited StatesUnknown status
Murfreesboro Medical Clinic Westlawn
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MurfreesboroUnited StatesUnknown status
Clinical Research Institute of Michigan, LLC-St. Claire Shores
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Saint Clair ShoresUnited StatesUnknown status
Onsite Clinical Solutions, LLC - Salisbury
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SalisburyUnited StatesUnknown status
University of Texas- San Antonio - Health Science Center - PPDS
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San AntonioUnited StatesUnknown status
Low Country Rheumatology PA-Summerville
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SummervilleUnited StatesUnknown status
West Broward Rheumatology Associates, Inc.
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TamaracUnited StatesUnknown status
BayCare Medical Group
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TampaUnited StatesUnknown status
University of Toledo Medical Center
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ToledoUnited StatesUnknown status
DM Clinical Research - Migraine and COPD - PPDS
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TomballUnited StatesUnknown status
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
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TucsonUnited StatesUnknown status
Inland Rheumatology Clinical Trials Incorporated
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UplandUnited StatesUnknown status
STAT Research-600 Aviator Ct
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VandaliaUnited StatesUnknown status
Arthritis, Rheumatic & Bone Disease Associates - Voorhees
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Voorhees TownshipUnited StatesUnknown status

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