New drug shows promise for Sjögren's syndrome in Long-Term safety trial
NCT ID NCT06747949
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at the long-term safety of a drug called dazodalibep for people with Sjögren's syndrome, an autoimmune disease that causes dry eyes and mouth. About 844 people who completed a prior phase 3 study will receive the drug for up to 48 more weeks. The main goal is to track side effects and how the body processes the drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 844 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: * Participant has provided informed consent before initiation of any study specific activities/procedures. * Must have been eligible to receive and have received IP (dazodalibep or placebo) and completed the study (through Week 48) in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303). * Must be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for the prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303). Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Clinically significant active infection at Day 1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication. * Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded. * Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with IP administration. * Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety. * Individuals who plan to receive live (attenuated) vaccine during the LTE study. * Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 weeks after the last dose of investigational product. * Female participants who are pregnant or lactating or planning to become pregnant during the study. * Participant has known sensitivity to any of the products or components to be administered during dosing. * Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge. * History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation.
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Sjögren's syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
174 sites in 26 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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A.O.U. Città della Salute e della Scienza di Torino
RECRUITINGTurin, Piedmont, 10126, Italy
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AP-HP - Hôpital Saint Antoine
RECRUITINGParis, 75012, France
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AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova
RECRUITINGReggio Emilia, 42123, Italy
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Accurate Clinical Management-Baytown
RECRUITINGBaytown, Texas, 77521-2279, United States
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Advanced Rheumatology of Houston
RECRUITINGThe Woodlands, Texas, 77382-2935, United States
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Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS
RECRUITINGPapatoetoe, 2025, New Zealand
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Aprillus Asistencia e Investigacion - Terrada 89
RECRUITINGBuenos Aires, 1406, Argentina
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Arizona Arthritis & Rheumatology Associates - Avondale
RECRUITINGAvondale, Arizona, 85392, United States
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Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
RECRUITINGFlagstaff, Arizona, 86001-6269, United States
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Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
RECRUITINGGilbert, Arizona, 85297-7336, United States
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Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
RECRUITINGGlendale, Arizona, 85306-9800, United States
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Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
RECRUITINGTucson, Arizona, 85704-1139, United States
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Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
RECRUITINGMiamisburg, Ohio, 45342-3585, United States
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Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd
RECRUITINGCharlotte, North Carolina, 28207-1100, United States
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Arthritis, Rheumatic & Bone Disease Associates - Voorhees
RECRUITINGVoorhees Township, New Jersey, 08043-4501, United States
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Azienda Ospedaliera Universitaria Integrata Di Verona
RECRUITINGVerona, Veneto, 37126, Italy
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Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
RECRUITINGPisa, 56126, Italy
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Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
RECRUITINGUdine, Friuli Venezia Giulia, 33100, Italy
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BIOCINETIC Ltda
RECRUITINGSantiago, 8350595, Chile
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BayCare Medical Group Primary Care and Rheumatology - Tampa
RECRUITINGTampa, Florida, 33614-7101, United States
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Bekes Varmegyei Kozponti Korhaz
RECRUITINGGyula, Bekes County, 5700, Hungary
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Biopharma Informatic - Ridge Road - PPDS
RECRUITINGMcAllen, Texas, 78503-1527, United States
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Bradenton Research Center Inc
RECRUITINGBradenton, Florida, 34205-1704, United States
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C.H. Regional Reina Sofia - PPDS
RECRUITINGCórdoba, Córdoba, 14004, Spain
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CHU de Bordeaux - Hôpital Saint-André
RECRUITINGBordeaux, 33000, France
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CHU de Brest - Hôpital La Cavale Blanche
RECRUITINGBrest, 29200, France
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Centro Medico Arsema
RECRUITINGBuenos Aires, C1427CCL, Argentina
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Centro Medico Privado de Reumatologia - PPDS
RECRUITINGSan Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
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Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
RECRUITINGSan Juan, J5402DIL, Argentina
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Centro de Estudios de Investigacion Basica Y Clinica SC
RECRUITINGGuadalajara, Jalisco, 44690, Mexico
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Centro de Estudos em Terapias Inovadoras
RECRUITINGCuritiba, Paraná, 80030-110, Brazil
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Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
RECRUITINGViña del Mar, Valparaiso, 2520000, Chile
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Centro de Investigaciones Reumatológicas
RECRUITINGSan Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
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Centro de Investigación en Artritis y Osteoporosis - PPDS
RECRUITINGMexicali, Estado de Baja California, 21200, Mexico
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Centro de Investigación y Tratamiento Reumatológico S.C
RECRUITINGMexico City, Mexico City, 11850, Mexico
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Centro de especialidades médicas Vanguardia
RECRUITINGTemuco, 4810345, Chile
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Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
RECRUITINGMalbork, Pomeranian Voivodeship, 82-200, Poland
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Centrum Medyczne K2J2 - Wołomin
RECRUITINGWołomin, Masovian Voivodeship, 05-200, Poland
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Centrum Medyczne Oporow
RECRUITINGWroclaw, Lower Silesian Voivodeship, 52-416, Poland
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Centrum Medyczne PROMED- Olszanska 5G
RECRUITINGKrakow, 31-513, Poland
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Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
RECRUITINGKrakow, 30-363, Poland
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Centrum Medyczne Pratia Katowice - PPDS
RECRUITINGKatowice, 40-081, Poland
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Centrum Medyczne Reuma Park
RECRUITINGWarsaw, Masovian Voivodeship, 02-665, Poland
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Chang Gung Memorial Hospital, Linkou
RECRUITINGTaoyuan, 33305, Taiwan
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Chapel Allerton Hospital - PPDS
RECRUITINGLeeds, LS7 4SA, United Kingdom
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Chubu Rosai Hospital
RECRUITINGNagoya-shi, Akita, 455-0018, Japan
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Clinica San Antonio S.A.C
RECRUITINGTrujillo, La Libertad, 13008, Peru
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Clinical Centre of Vojvodina
RECRUITINGNovi Sad, 21000, Serbia
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Clinical Research Chile SpA - PPDS
RECRUITINGValdivia, 5110683, Chile
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Clinical Research of West Florida Inc - Clearwater
RECRUITINGClearwater, Florida, 33765-2616, United States
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Clinique de Rhumatologie Du Centre Du Quebec
RECRUITINGTrois-Rivières, Quebec, G8Z 1Y2, Canada
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Clinstile, S.A. de C.V.
RECRUITINGMexico City, 6700, Mexico
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Clínica Mayo de U.M.C.B. S.R.L
RECRUITINGSan Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina
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Consultorio de Reumatologia
RECRUITINGMéxico, 7760, Mexico
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Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
RECRUITINGCiudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina
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Cryptex Investigación Clínica, S.A. de C.V.
RECRUITINGMexico City, Mexico City, 6100, Mexico
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DM Clinical Research - Migraine and COPD - PPDS
RECRUITINGTomball, Texas, 77375, United States
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DOM Centro de Reumatología
RECRUITINGBuenos Aires, Ciudad Autónoma de BuenosAires, C1111, Argentina
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Daido Clinic
RECRUITINGNagoya, Akita, 457-8511, Japan
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Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
RECRUITINGDebrecen, Hajdú-Bihar, 4032, Hungary
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Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7
RECRUITINGBudapest, 1097, Hungary
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Duke Early Phase Clinical Research Unit - PPDS
RECRUITINGDurham, North Carolina, 27710-0001, United States
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ETG Lublin - PPDS
RECRUITINGLublin, Lublin Voivodeship, 20-412, Poland
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ETG Warszawa - PPDS
RECRUITINGWarsaw, 02-677, Poland
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Enroll SpA - Dr. Manuel Barros Borgono - PPDS
RECRUITINGProvidencia, 7500000, Chile
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Euromedica Kianous Stavros
RECRUITINGThessaloniki, 546 36, Greece
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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITINGMilan, Lombardy, 20122, Italy
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Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
RECRUITINGRome, Lazio, 00168, Italy
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Fondazione Policlinico Universitario Campus Bio-Medico
RECRUITINGRome, Lazio, 128, Italy
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Framingham Centro Médico
RECRUITINGLa Plata, B1902COS, Argentina
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Fundacio Hospital de l'Esperit Sant
RECRUITINGSanta Coloma de Gramenet, Barcelona, 08923, Spain
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FutureMeds - Lodz - PPDS
RECRUITINGLodz, 91-363, Poland
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FutureMeds - Targowek - PPDS
RECRUITINGWarsaw, 03-291, Poland
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FutureMeds - Wroclaw - PPDS
RECRUITINGWroclaw, 53-673, Poland
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GHRMSA - Hôpital Emile Muller
RECRUITINGMulhouse, 68100, France
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Hamamatsu University Hospital
RECRUITINGHamamatsu, Shizuoka, 431-3192, Japan
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Health New Zealand - Te Whatu Ora - Waikato (Waikato Hospital)
RECRUITINGHamilton, 3240, New Zealand
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Hokkaido University Hospital
RECRUITINGSapporo, Hokkaidô, 060-8648, Japan
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Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
RECRUITINGPonte de Lima, 4990-150, Portugal
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Hospital General de Agudos Dr. José María Ramos Mejia
RECRUITINGBuenos Aires, C1121ADC, Argentina
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Hospital Militar Central Luis Arias Schereiber
RECRUITINGJesus Maria, 15001, Peru
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Hospital Quironsalud Infanta Luisa
RECRUITINGSeville, 41010, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, 28041, Spain
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Hospital Universitario Infanta Leonor
RECRUITINGMadrid, 28031, Spain
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Hospital Universitario de Basurto
RECRUITINGBilbao, Vizcaya, 48013, Spain
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Hospital Universitario de Valme
RECRUITINGSeville, 41014, Spain
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Hospital of the University of Occupational and Environmental Health, Japan
RECRUITINGKita Kyushu-shi, Hukuoka, 807-8556, Japan
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Houston Rheumatology & Arthritis Specialists - PLLC - PPDS
RECRUITINGKaty, Texas, 77494-1341, United States
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Hôpitaux Universitaires de Strasbourg
RECRUITINGStrasbourg, 67091, France
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Institute of Rheumatology - PPDS
RECRUITINGBelgrade, 11000, Serbia
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Instituto CER S.A.
RECRUITINGQuilmes, Buenos Aires, B1878DVB, Argentina
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Instituto de Ginecologia y Reproduccion - PPDS
RECRUITINGSantiago de Surco, 33, Peru
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Instituto de Investigaciones Clinicas Quilmes SRL
RECRUITINGQuilmes, Buenos Aires, B1878GEG, Argentina
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Japan Community Health Care Organization (JCHO) Chukyo Hospital
RECRUITINGNagoya-shi, Akita, 457-0866, Japan
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Kanazawa Medical University Hospital
RECRUITINGKahoku, Ishikawa-ken, 920-0293, Japan
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Kanazawa University Hospital
RECRUITINGKanazawa, Ishikawa-ken, 920-8641, Japan
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Kansas City Physician Partners-8350 N Saint Clair Ave
RECRUITINGKansas City, Missouri, 64151, United States
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Kaohsiung Medical University - Chung-Ho Memorial Hospital
RECRUITINGKaohsiung City, 80756, Taiwan
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Keio University Hospital
RECRUITINGShinjuku-Ku, Tokyo, 160-8582, Japan
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Klinika za Alergologiju i Imunologiju
RECRUITINGBelgrade, 112108, Serbia
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Kurashiki Medical Clinic
RECRUITINGKurashiki-Shi, Okayama-ken, 710-0824, Japan
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Kyoto University Hospital
RECRUITINGKyoto, Kyôto, 606-8507, Japan
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LMK Servicos Medicos SS
RECRUITINGPorto Alegre, Rio Grande do Sul, 90480-000, Brazil
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Laiko General Hospital of Athens
RECRUITINGAthens, Attica, 115 27, Greece
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MICS Centrum Medyczne Bydgoszcz
RECRUITINGBydgoszcz, 85-065, Poland
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MICS Centrum Medyczne Warszawa, Wronia - MICS
RECRUITINGWarsaw, Masovian Voivodeship, 00-874, Poland
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MR Medicina Reumatologica
RECRUITINGSan Fernando, Buenos Aires, B1646GHP, Argentina
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MTZ Clinical Research Powered by PRATIA - PPDS
RECRUITINGWarsaw, Masovian Voivodeship, 02-172, Poland
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MVZ Rheuma
RECRUITINGHamburg, 20095, Germany
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Malopolskie Centrum Kliniczne
RECRUITINGKrakow, Lesser Poland Voivodeship, 30-149, Poland
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Med-Polonia Sp. z o.o.
RECRUITINGPoznan, Greater Poland Voivodeship, 60-693, Poland
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Mediadvance Clinical S.A.P.I. de C.V.
RECRUITINGParques de San Felipe, Chihuahua, 31203, Mexico
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Medicentro Biociencias Peru S.R.L.
RECRUITINGPueblo Libre, Lima region, 1508, Peru
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Meir Medical Center
RECRUITINGKafr Saba, Central District, 4428164, Israel
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Mile End Hospital - PPDS
RECRUITINGLondon, E1 4DG, United Kingdom
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Military Medical Academy
RECRUITINGBelgrade, Belgrade, 11000, Serbia
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Murfreesboro Medical Clinic Westlawn
RECRUITINGMurfreesboro, Tennessee, 37128, United States
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Nagasaki University Hospital
RECRUITINGNagasaki, Nagasaki, 852-8501, Japan
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Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
RECRUITINGWarsaw, 02-637, Poland
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National Hospital Organization Yokohama Medical Center
RECRUITINGYokohama, Kanagawa, 245-8575, Japan
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Naval Hospital of Athens
RECRUITINGAthens, Attica, 115 21, Greece
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Nihon University Itabashi Hospital
RECRUITINGItabashi-Ku, Tokyo, 173-0032, Japan
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Onsite Clinical Solutions, LLC - Salisbury
RECRUITINGSalisbury, North Carolina, 28144, United States
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Optimal Clinical Trials Ltd - PPDS
RECRUITINGAuckland, North Island, 1003, New Zealand
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Polyclinic Bonifarm
RECRUITINGZagreb, City of Zagreb, 10000, Croatia
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Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3
RECRUITINGWroclaw, 53-034, Poland
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Pratia Poznan - PPDS
RECRUITINGPoznan, Greater Poland Voivodeship, 60-192, Poland
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Precision Comprehensive Clinical Research Solutions
RECRUITINGColleyville, Texas, 76034-5913, United States
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Prywatna Praktyka Lekarska Pawel Hrycaj
RECRUITINGPoznan, 61-397, Poland
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Queen Alexandra Hospital
RECRUITINGPortsmouth, Hampshire, PO6 3LY, United Kingdom
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R & H Clinical Research-777 S Fry Rd
RECRUITINGKaty, Texas, 77450-2297, United States
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Rheumatology and Pulmonary Clinic
RECRUITINGBeckley, West Virginia, 25801-2805, United States
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Rheumazentrum Greifswald
RECRUITINGGreifswald Hansestadt, Mecklenburg-Vorpommern, 17493, Germany
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Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan
RECRUITINGBad Doberan, Mecklenburg-Vorpommern, 18209, Germany
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SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
RECRUITINGSalvador, Estado de Bahia, 40150-150, Brazil
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STAT Research-600 Aviator Ct
RECRUITINGVandalia, Ohio, 45377-9474, United States
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Saitama Medical University Hospital
RECRUITINGIruma-Gun Moroyama-Machi, Saitama, 350-0451, Japan
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Samy Metyas MD Inc
RECRUITINGCovina, California, 91723, United States
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Sanatorio Agote - Swiss Medical Group - PPDS
RECRUITINGBuenos Aires, C1425EOE, Argentina
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Sanatorio Allende S.A.-Hipolito Yrigoyen 384
RECRUITINGCórdoba, X5000JHQ, Argentina
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Sapporo Medical University Hospital
RECRUITINGSapporo, Hokkaidô, 060-8543, Japan
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Sasebo Chuo Hospital
RECRUITINGSasebo-Shi, Nagasaki, 857-1165, Japan
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Shores Rheumatology
RECRUITINGSaint Clair Shores, Michigan, 48081-1274, United States
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Special Hospital For Rheumatic Diseases Novi Sad
RECRUITINGNovi Sad, 21000, Serbia
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St. Luke's International Hospital
RECRUITINGChuo-Ku, Tokyo, 104-0044, Japan
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Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
RECRUITINGBydgoszcz, 85-168, Poland
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Taichung Veterans General Hospital
RECRUITINGTaichung, 40705, Taiwan
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Taipei Medical University Hospital - PPDS
RECRUITINGTaipei, 11031, Taiwan
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Tekton Research, LLC - 2121 E Harmony Rd - PPDS
RECRUITINGFort Collins, Colorado, 80528-3400, United States
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The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITINGSeoul, Seoul Teugbyeolsi, 6591, South Korea
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The Chaim Sheba Medical Center - PPDS
RECRUITINGRamat Gan, Tel Aviv, 5262100, Israel
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The Queen Elizabeth Hospital
RECRUITINGWoodville South, South Australia, 5011, Australia
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Tokyo Medical Center
RECRUITINGMeguro-Ku, Tokyo, 152-0021, Japan
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Tufts University School of Dental Medicine
RECRUITINGBoston, Massachusetts, 02111-1527, United States
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Twoja Przychodnia PCM
RECRUITINGPoznan, 60-324, Poland
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UCSD Altman Clinical and Translational Research Institute Building
RECRUITINGLa Jolla, California, 92037-1337, United States
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ULS de Gaia/Espinho, EPE - Unidade I
RECRUITINGVila Nova de Gaia, 4434-502, Portugal
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ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
RECRUITINGLisbon, Lisbon District, 1349-019, Portugal
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ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
RECRUITINGLisbon, Lisbon District, 1649-035, Portugal
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UZ Gent
RECRUITINGGhent, 9000, Belgium
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Unidad de Atención Medica e Investigación en Salud
RECRUITINGMérida, 97000, Mexico
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University Clinic Heidelberg
RECRUITINGHeidelberg, Baden-Wurttemberg, 69120, Germany
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University Clinical Center Kragujevac
RECRUITINGKragujevac, 34000, Serbia
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University Clinical Centre Maribor
RECRUITINGMaribor, 2000, Slovenia
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University General Hospital of Larissa
RECRUITINGLarissa, Larisa, 411 10, Greece
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University Hospital of Split
RECRUITINGSplit, 21000, Croatia
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University Hospital, Kyoto Prefectural University of Medicine
RECRUITINGKyoto, Kyôto, 602-8566, Japan
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University of Toledo Medical Center
RECRUITINGToledo, Ohio, 43614-2595, United States
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University of Tsukuba Hospital
RECRUITINGTsukuba, Ibaraki, 305-8576, Japan
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Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213
RECRUITINGWroclaw, 50-556, Poland
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Vasarhelyi Sarkanyfu Kft.
RECRUITINGHódmezovásárhely, Csongrád megye, 6800, Hungary
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WIM-PIB, Centralny Szpital Kliniczny MON
RECRUITINGWarsaw, Masovian Voivodeship, 04-141, Poland
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Western Washington Medical Group, Bothell - Rheumatology
RECRUITINGBothell, Washington, 98021, United States
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Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4
RECRUITINGLublin, Lublin Voivodeship, 20-607, Poland
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