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NCT03915964CompletedPhase 4

A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis

A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

Source: ClinicalTrials.gov · Last updated 24 Jun 2026

Brief summary (registry, in English)

This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
2659 (actual)
First submitted
12 Apr 2019
Start date
25 Apr 2019
Primary completion date
28 May 2025
Lead sponsor
Eli Lilly and Company
NCT number
NCT03915964
EU CT number
2023-508022-10-00
EudraCT number
2018-003351-37

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 2659
  • From 25 Apr 2019 to the primary completion date, 28 May 2025
  • 246 sites in 24 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

  • Participant should have no reason to not take a TNF inhibitor.
  • Participants must not have had a live vaccine within four weeks of study start.

Other illness

  • Participants must not have cancer.
  • Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness.
  • Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.

Other

  • Participants must not be pregnant or breastfeeding.
  • Participants must not have had more than one VTE.
  • Participants must not have participated in any other clinical trial within four weeks of study start.

Who the study is looking for

  • Participants must have at least one of the following characteristics:
    • Documented evidence of a VTE prior to this study
    • At least 60 years of age
    • A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or
    • Age 50 to less than 60 years and BMI 25 to less than 30 kg/m².
  • Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drug (DMARD) (synthetic or biologic).

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

Full criteria on ClinicalTrials.gov

Sites (246)

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

SiteCityCountrySite status
Stadt Wien Wiener Gesundheitsverbund
Coordinator of this site? Confirm its status
ViennaAustriaCompleted
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Coordinator of this site? Confirm its status
ViennaAustriaCompleted
Optimus Clinical Research
Coordinator of this site? Confirm its status
BotanyAustraliaUnknown status
Emeritus Research
Coordinator of this site? Confirm its status
CamberwellAustraliaUnknown status
Southern Clinical Research
Coordinator of this site? Confirm its status
HobartAustraliaUnknown status
Rheumatology Research Unit
Coordinator of this site? Confirm its status
MaroochydoreAustraliaUnknown status
Genesis Research Services
Coordinator of this site? Confirm its status
NewcastleAustraliaUnknown status
Hopital Erasme
Coordinator of this site? Confirm its status
AnderlechtBelgiumCompleted
Het Ziekenhuisnetwerk Antwerpen
Coordinator of this site? Confirm its status
AntwerpBelgiumCompleted
ReumaClinic
Coordinator of this site? Confirm its status
GenkBelgiumCompleted
University Hospital Basel
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status
HFR Fribourg - Hôpital cantonal
Coordinator of this site? Confirm its status
FribourgSwitzerlandUnknown status
Cantonal Hospital St Gallen
Coordinator of this site? Confirm its status
Sankt GallenSwitzerlandUnknown status
Revmatologie s.r.o.
Coordinator of this site? Confirm its status
Brno-SeverCzechiaCompleted
Revmaclinic s.r.o.
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Brno-StredCzechiaCompleted
Revmacentrum MUDr Mostera s r o
Coordinator of this site? Confirm its status
Brno-ŽideniceCzechiaCompleted
INREA s.r.o.
Coordinator of this site? Confirm its status
OstravaCzechiaCompleted
ARTHROHELP s.r.o.
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PardubiceCzechiaCompleted
MuDr. Zuzana Stejfova
Coordinator of this site? Confirm its status
PragueCzechiaCompleted
Clintrial s.r.o.
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Prague 10CzechiaCompleted
Affidea Praha s.r.o.
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Prague 11CzechiaCompleted
Revmatologicky Ustav
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Prague 2CzechiaCompleted
MUDR. Zuzana URBANOVA
Coordinator of this site? Confirm its status
Prague 4CzechiaCompleted
Artroscan s.r.o.
Coordinator of this site? Confirm its status
TreboviceCzechiaCompleted
MEDICAL PLUS s.r.o.
Coordinator of this site? Confirm its status
Uherské HradištěCzechiaCompleted
PV Medical S R O
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ZlínCzechiaCompleted
BIOMEDRO Biomedizinische Forschung und Entwicklung GmbH
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Bad DoberanGermanyCompleted
Schlosspark-Klinik GmbH
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BerlinGermanyCompleted
University Hospital Cologne AöR
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CologneGermanyCompleted
Goethe University Frankfurt
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Frankfurt Am MainGermanyCompleted
Rheumapraxis Hamburg
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HamburgGermanyCompleted
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
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HamburgGermanyCompleted
Institut Fuer Praeventive Medizin & Klinische Forschung GbR
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MagdeburgGermanyCompleted
Rheumazentrum Ratingen
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RatingenGermanyCompleted
Region Midtjylland
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HerningDenmarkCompleted
Region Midtjylland
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SilkeborgDenmarkCompleted
Odense University Hospital
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SvendborgDenmarkCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Quirónsalud Barcelona
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Clinica Sagrada Familia
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BarcelonaSpainCompleted
Hospital Universitario Basurto
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BilbaoSpainCompleted
Hospital Universitario de Fuenlabrada
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FuenlabradaSpainCompleted
Hospital Universitario de Getafe
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GetafeSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Parc Tauli Hospital Universitari
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SabadellSpainCompleted
Clínica Gaias - Santiago
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Santiago de CompostelaSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
Hospital De Sant Joan Despi Moisés Broggi
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Sant Joan DespíSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Hospital Quironsalud Infanta Luisa
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SevillaSpainCompleted
Complexo Hospitalario Universitario De Vigo
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VigoSpainCompleted
Hospital Marina Baixa De La Vila Joiosa
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VillajoyosaSpainCompleted
Pellegrin Hospital
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BordeauxFranceCompleted
Ass Hospitaliere Protestante De Lyon
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Caluire-Et-CuireFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Centre Hospitalier Regional D'orleans
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Orleans Cedex 2FranceCompleted
University Hospitals Pitie Salpetriere - Charles Foix
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ParisFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
Mid Essex Hospital Services NHS Trust
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ChelmsfordUnited KingdomUnknown status
Christchurch Hospital
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ChristchurchUnited KingdomUnknown status
The Dudley Group Nhs Foundation Trust
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DudleyUnited KingdomUnknown status
Hull and East Yorkshire Hospitals NHS Trust
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HullUnited KingdomUnknown status
Aintree University Hospital NHS Foundation Trust
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LiverpoolUnited KingdomUnknown status
Royal Free London NHS Foundation Trust
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LondonUnited KingdomUnknown status
Barts Health NHS Trust - Whipps Cross University Hospital
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LondonUnited KingdomUnknown status
Northumbria Healthcare NHS Foundation Trust
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Newcastle upon TyneUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Queen Alexandra Hospital
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PortsmouthUnited KingdomUnknown status
King's Mill Hospital
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Sutton in AshfieldUnited KingdomUnknown status
Torbay Hospital
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TorquayUnited KingdomUnknown status
The Royal Cornwall Hospital
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TruroUnited KingdomUnknown status
New Cross Hospital
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WolverhamptonUnited KingdomUnknown status
University General Hospital of Alexandroupoli
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AlexandroupoliGreeceCompleted
University General Hospital Attikon
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AthensGreeceCompleted
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceCompleted
Revita Kft.
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Budapest IIHungaryCompleted
Clinexpert Kft.
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Budapest IIIHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
CRU Hungary Kft.
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EncsHungaryCompleted
Vital-Medicina Kft.
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VeszpremHungaryCompleted
Barzilai Medical Center
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AshkelonIsraelUnknown status
Carmel Hospital
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HaifaIsraelUnknown status
Rambam Health Care Campus
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HaifaIsraelUnknown status
Bnai Zion Medical Center
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HaifaIsraelUnknown status
Meir Medical Center
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Kfar SabaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Sourasky Medical Center
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Tel AvivIsraelUnknown status
Universita' Degli Studi G. D'annunzio Di Chieti
Coordinator of this site? Confirm its status
ChietiItalyCompleted
Careggi University Hospital
Coordinator of this site? Confirm its status
FlorenceItalyCompleted
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
Coordinator of this site? Confirm its status
NaplesItalyCompleted
Universita' Degli Studi Di Verona
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VeronaItalyCompleted
Republican Kaunas Hospital, Public Institution
Coordinator of this site? Confirm its status
KaunasLithuaniaCompleted
Republican Siauliai Hospital, Public Institution
Coordinator of this site? Confirm its status
SiauliaiLithuaniaCompleted
Center Outpatient Clinic, Public Institution
Coordinator of this site? Confirm its status
VilniusLithuaniaCompleted
PreCare Trial & Recruitment B.V.
Coordinator of this site? Confirm its status
Beek LbNetherlandsCompleted
Medisch Centrum Leeuwarden B.V.
Coordinator of this site? Confirm its status
LeeuwardenNetherlandsCompleted
Osteo Medic sc A. Racewicz, J. Supronik
Coordinator of this site? Confirm its status
BialystokPolandCompleted
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Coordinator of this site? Confirm its status
BydgoszczPolandCompleted
BIF-MED
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BytomPolandCompleted
Ambulatorium Sp. z o.o.
Coordinator of this site? Confirm its status
ElblagPolandCompleted
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandCompleted
Pratia S.A.
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KatowicePolandCompleted
NZOZ Lecznica MAK MED S C
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NadarzynPolandCompleted
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Coordinator of this site? Confirm its status
Nowa SolPolandCompleted
Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj
Coordinator of this site? Confirm its status
PoznanPolandCompleted
Ai Centrum Medyczne Sp. z o.o. S.K.
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PoznanPolandCompleted
Samodzielny Publiczny Zespół Opieki Zdrowotnej w Tomaszowie Lubelskim
Coordinator of this site? Confirm its status
Tomaszów LubelskiPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
Coordinator of this site? Confirm its status
TorunPolandCompleted
Sląskie Centrum Reumatologii Ortopedii I Rehabilitacji W Ustroniu Sp. z o.o.
Coordinator of this site? Confirm its status
UstronPolandCompleted
Centrum Medyczne Amed Sp. z o.o.
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WarsawPolandCompleted
Klinika Reuma Park Sp. z o.o. S.K.
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WarsawPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Etg Warszawa Sp. z o.o.
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WarsawPolandCompleted
Rheuma Medicus Sp z o o
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WarsawPolandCompleted
Centro Reumatologico Caguas
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CaguasPuerto RicoUnknown status
Ponce Medical School Foundation Inc.
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PoncePuerto RicoUnknown status
Latin Clinical Trial Center
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San JuanPuerto RicoUnknown status
GCM Medical Group, PSC - Hato Rey Site
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San JuanPuerto RicoUnknown status
Mindful Medical Research
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San JuanPuerto RicoUnknown status
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
Coordinator of this site? Confirm its status
Baia MareRomaniaCompleted
CMI Cristei Dorica
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BrăilaRomaniaCompleted
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
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BrasovRomaniaCompleted
Delta Health Care S.R.L
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BucharestRomaniaCompleted
Saint Maria Hospital
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BucharestRomaniaCompleted
Policlinica CCBR S.R.L.
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BucharestRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Sf. Apostol Andrei Galati
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GalatiRomaniaCompleted
Medaudio Optica S R L
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Râmnicu VâlceaRomaniaCompleted
Kursk Regional Clinical Hospital
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KurskRussiaUnknown status
M. F. Vladimirskiy Moscow Regional Research Clinical Institute
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MoscowRussiaUnknown status
Moscow Clinical Research Center
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MoscowRussiaUnknown status
First Moscow State Medical University I.M. Sechenov
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MoscowRussiaUnknown status
Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
Nizhny Novgorod City Clinical Hospital Number 5
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Nizhny NovgorodRussiaUnknown status
Karelia Republican Hospital V.A. Baranova
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PetrozavodskRussiaUnknown status
Ryazan Regional Clinical Cardiological Dispensary
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RyazanRussiaUnknown status
Clinical Rheumatology hospital #25
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Saint PetersburgRussiaUnknown status
North-Western State Medical University named after I.I. Mechnikov
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Saint PetersburgRussiaUnknown status
Gbuz Lokb
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Saint-PetersburgRussiaUnknown status
Regional Clinical Hospital of the Saratov Region
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SaratovRussiaUnknown status
Tula Regional Clinical Hospital
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TulaRussiaUnknown status
GUZ UOKB
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UlyanovskRussiaUnknown status
Research & Practice
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YaroslavlRussiaUnknown status
Artromac n.o.
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KošiceSlovakiaCompleted
Reumacentrum s.r.o.
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PartizánskeSlovakiaCompleted
Romjan s.r.o.
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PetrzalkaSlovakiaCompleted
Reumed s.r.o.
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Spišská Nová VesSlovakiaCompleted
LERAM s.r.o.
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TopoľčanySlovakiaCompleted
Albamed s.r.o.
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ZvolenSlovakiaCompleted
Albuquerque Clinical Trials, Inc.
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AlbuquerqueUnited StatesUnknown status
Albuquerque Center for Rheumatology
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AlbuquerqueUnited StatesUnknown status
Arthritis & Rheumatology of Georgia
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AtlantaUnited StatesUnknown status
Accurate Clinical Management
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BaytownUnited StatesUnknown status
East Penn Rheumatology Associates
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BethlehemUnited StatesUnknown status
Rheumatology Associates Of South Florida
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Boca RatonUnited StatesUnknown status
St. Luke's Intermountain Research Center
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BoiseUnited StatesUnknown status
University of Michigan
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BrightonUnited StatesUnknown status
CAMC Health Education and Research Institute Inc
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CharlestonUnited StatesUnknown status
Accellacare - Charlotte
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CharlotteUnited StatesUnknown status
Great Lakes Clinical Trials
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ChicagoUnited StatesUnknown status
Cincinnati Rheumatic Disease Study Group
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CincinnatiUnited StatesUnknown status
StudyMetrix Research
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City of Saint PetersUnited StatesUnknown status
Arthritis & Osteoporosis Clinic of Brazos Valley
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College StationUnited StatesUnknown status
Medvin Clinical Research - Covina
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CovinaUnited StatesUnknown status
Altoona Center For Clinical Research
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DuncansvilleUnited StatesUnknown status
M3-Emerging Medical Research, LLC
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DurhamUnited StatesUnknown status
Center For Arthritis and Osteoporosis
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ElizabethtownUnited StatesUnknown status
Qualmedica Research, LLC
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EvansvilleUnited StatesUnknown status
NECCR PrimaCare Research
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Fall RiverUnited StatesUnknown status
Arizona Arthritis & Rheumatology Research, PLLC
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FlagstaffUnited StatesUnknown status
St. Joseph Heritage Healthcare
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FullertonUnited StatesUnknown status
Arthritis Center of North Georgia
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GainesvilleUnited StatesUnknown status
Arthrocare, Arthritiscare & Research PC
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GilbertUnited StatesUnknown status
Arizona Arthritis & Rheumatology Research, PLLC
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GlendaleUnited StatesUnknown status
West Michigan Rheumatology
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Grand RapidsUnited StatesUnknown status
Piedmont Rheumatology, P.A.
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HickoryUnited StatesUnknown status
Research Physicians Network, LLC
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HoustonUnited StatesUnknown status
Accurate Clinical Management - Houston
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HoustonUnited StatesUnknown status
Accurate Clinical Research
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HoustonUnited StatesUnknown status
Biopharma Informatic, LLC
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HoustonUnited StatesUnknown status
Christine Thai, MD
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Huntington BeachUnited StatesUnknown status
Private Practice - Dr. Christine J. Leehealey
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IrvineUnited StatesUnknown status
Glacier View Research Institute
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KalispellUnited StatesUnknown status
Accurate Clinical Research
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Lake CharlesUnited StatesUnknown status
Accurate Clinical Research
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League CityUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
Cape Fear Arthritis Care
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LelandUnited StatesUnknown status
Physician Research Collaboration, LLC
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LincolnUnited StatesUnknown status
Marietta Memorial Hospital
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MariettaUnited StatesUnknown status
Arizona Arthritis & Rheumatology Research, PLLC
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MesaUnited StatesUnknown status
New Horizon Research Center
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MiamiUnited StatesUnknown status
Suncoast Research Group
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MiamiUnited StatesUnknown status
Paramount Medical Research & Consulting, LLC
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Middleburg HeightsUnited StatesUnknown status
Suncoast Clinical Research, Inc.
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New Port RicheyUnited StatesUnknown status
Advanced Rheumatology, PC
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OkemosUnited StatesUnknown status
Health Research of Oklahoma
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Oklahoma CityUnited StatesUnknown status
Oklahoma Medical Research Foundation
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Oklahoma CityUnited StatesUnknown status
Westroads Clinical Research, Inc.
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OmahaUnited StatesUnknown status
Hope Research Institute
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PeoriaUnited StatesUnknown status
Hope Research Institute
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PhoenixUnited StatesUnknown status
IRIS Research and Development LLC
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PlantationUnited StatesUnknown status
Desert Medical Advances
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Rancho MirageUnited StatesUnknown status
Regional Health Clinical Research
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Rapid CityUnited StatesUnknown status
Allied Clinical Research
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RenoUnited StatesUnknown status
PMG Research of Salisbury
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SalisburyUnited StatesUnknown status
Clinical Trials of Texas Inc
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San AntonioUnited StatesUnknown status
Accurate Clinical Research, Inc.
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San AntonioUnited StatesUnknown status
Rheumatology Center of San Diego
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San DiegoUnited StatesUnknown status
East Bay Rheumatology Medical Group, Inc
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San LeandroUnited StatesUnknown status
Santa Fe Rheumatology
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Santa FeUnited StatesUnknown status
Qps-Mra, Llc
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South MiamiUnited StatesUnknown status
Arthritis Northwest, PLLC
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SpokaneUnited StatesUnknown status
Clinvest Research, LLC
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SpringfieldUnited StatesUnknown status
Stamford Therapeutics Consortium
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StamfordUnited StatesUnknown status
Accurate Clinical Management
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Sugar LandUnited StatesUnknown status
ForCare Clinical Research
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TampaUnited StatesUnknown status
Dynamed Clinical Research, LP d/b/a DM Clinical Research
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TomballUnited StatesUnknown status
DM Clinical Research/Rheumatology Clinic of Houston
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TomballUnited StatesUnknown status
Arizona Arthritis & Rheumatology Research, PLLC
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TucsonUnited StatesUnknown status
Dan La, MD Inc
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TujungaUnited StatesUnknown status
Robin K. Dore MD, Inc
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TustinUnited StatesUnknown status
Inland Rheumatology & Osteoporosis Medical Group
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UplandUnited StatesUnknown status
The Vancouver Clinic
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VancouverUnited StatesUnknown status
Medvin Clinical Research - Weidmann
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Van NuysUnited StatesUnknown status
The Center For Rheumatology And Bone Research
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WheatonUnited StatesUnknown status
Medvin Clinical Research - Whittier
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WhittierUnited StatesUnknown status
Alliance for Multispecialty Research LLC
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WichitaUnited StatesUnknown status
PMG Research of Wilmington, LLC
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WilmingtonUnited StatesUnknown status
Clinical Research Center of Reading LLC
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WyomissingUnited StatesUnknown status
Pennsylvania Regional Center for Arthritis and Osteoporosis Research
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WyomissingUnited StatesUnknown status
FARMOVS
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BloemfonteinSouth AfricaUnknown status
IATROS International
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BloemfonteinSouth AfricaUnknown status
Arthritis Clinical Trial Centre
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Cape TownSouth AfricaUnknown status
Precise Clinical Solutions
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ChatsworthSouth AfricaUnknown status
Clinresco Centres
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Kempton ParkSouth AfricaUnknown status
Netcare Greenacres Hospital
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Port ElizabethSouth AfricaUnknown status
University of Pretoria - Faculty of Health Sciences
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PretoriaSouth AfricaUnknown status
Winelands Medical Research Centre
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StellenboschSouth AfricaUnknown status
Netcare Umhlanga Hospital
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UmhlangaSouth AfricaUnknown status
Trakya University
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EdirneTurkey (Türkiye)Unknown status
Eskisehir Osmangazi University
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EskişehirTurkey (Türkiye)Unknown status
Istanbul University Cerrahpasa Medical School Internal Diseases Institute
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IstanbulTurkey (Türkiye)Unknown status
Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
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IzmirTurkey (Türkiye)Unknown status
Necmettin Erbakan Meram Medical Fac.
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KonyaTurkey (Türkiye)Unknown status
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
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StanbulTurkey (Türkiye)Unknown status

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