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NCT03104374CompletedPhase 3

A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug

A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)

Source: ClinicalTrials.gov · Last updated 11 Sept 2025

Brief summary (registry, in English)

This is a Phase 3 multicenter study that included two periods. Period 1 was designed to compare the safety, tolerability, and efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who had an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluated the safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in subjects with PsA who completed Period 1.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
642 (actual)
First submitted
4 Apr 2017
Start date
1 May 2017
Primary completion date
23 Jul 2019
Lead sponsor
AbbVie
NCT number
NCT03104374
EudraCT number
2016-004152-30

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 642
  • From 1 May 2017 to the primary completion date, 23 Jul 2019
  • 165 sites in 19 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

  • Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
  • Current treatment with \> 2 non-biologic DMARDs or use of DMARDs other than Methotrexate (MTX), Sulfasalazine (SSZ), Leflunomide (LEF), apremilast, Hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
  • History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

Who the study is looking for

  • Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
  • Participant has active disease at Baseline defined as \>= 3 tender joints (based on 68 joint counts) and \>= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
  • Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
  • Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) or intolerance to treatment with at least 1 bDMARD.

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

Full criteria on ClinicalTrials.gov

Sites (165)

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

SiteCityCountrySite status
Emeritus Research Sydney /ID# 166751
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BotanyAustraliaUnknown status
Box Hill Hospital /ID# 166752
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Box HillAustraliaUnknown status
Heidelberg Repatriation Hospital /ID# 167441
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Heidelberg WestAustraliaUnknown status
The Queen Elizabeth Hospital /ID# 200840
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Woodville SouthAustraliaUnknown status
ReumaClinic /ID# 164214
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GenkBelgiumUnknown status
UZ Gent /ID# 164210
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GhentBelgiumUnknown status
CIP - Centro Internacional de Pesquisa /ID# 161808
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GoiâniaBrazilUnknown status
LMK Sevicos Medicos S/S /ID# 161806
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Porto AlegreBrazilUnknown status
Hospital de Clinicas de Porto Alegre /ID# 161795
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Porto AlegreBrazilUnknown status
Duplicate_Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 163317
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Ribeirão PretoBrazilUnknown status
Faculdade de Medicina do ABC /ID# 163489
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Santo AndréBrazilUnknown status
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 161793
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São PauloBrazilUnknown status
Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794
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UberlândiaBrazilUnknown status
The Waterside Clinic /ID# 157838
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OrilliaCanadaUnknown status
Groupe de Recherche en Maladies Osseuses Inc /ID# 157836
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Sainte-FoyCanadaUnknown status
Centre de Recherche Musculo-Squelettique /ID# 163557
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Trois-RivièresCanadaUnknown status
Percuro Clinical Research, Ltd /ID# 157835
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VictoriaCanadaUnknown status
CIADS Research Co Ltd /ID# 157843
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WinnipegCanadaUnknown status
CTR Estudios Clinicos /ID# 206038
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ProvidenciaChileUnknown status
Duplicate_Centro Internacional de Estudios Clinicos /ID# 169543
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SantiagoChileUnknown status
Duplicate_Clinica Dermacross /ID# 169537
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SantiagoChileUnknown status
Prosalud Ltda. /ID# 169542
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SantiagoChileUnknown status
Revmatologie Bruntal, s.r.o /ID# 159632
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ProstějovCzechiaUnknown status
Medical Plus, s.r.o. /ID# 159631
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Uherské HradištěCzechiaUnknown status
Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 161019
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A CoruñaSpainUnknown status
Duplicate_Hospital Universitario Reina Sofia /ID# 170764
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CórdobaSpainUnknown status
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 163138
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El PalmarSpainUnknown status
Hospital Campus de la Salud /ID# 170768
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GranadaSpainUnknown status
Hospital Universitario Ramon y Cajal /ID# 161020
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MadridSpainUnknown status
CHRU Tours - Hopital Trousseau /ID# 163772
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Chambray-lès-ToursFranceUnknown status
Duplicate_CHU-Hospital Henri Mondor /ID# 163895
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CréteilFranceUnknown status
Centre Hospitalier du Mans /ID# 163746
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Le MansFranceUnknown status
Hopital Saint Joseph /ID# 163755
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MarseilleFranceUnknown status
Duplicate_AP-HP - Hopital Lariboisiere /ID# 163773
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ParisFranceUnknown status
CHU Toulouse /ID# 163743
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ToulouseFranceUnknown status
Royal United Hospitals Bath /ID# 161054
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BathUnited KingdomUnknown status
Duplicate_NHS Greater Glasgow and Clyde /ID# 162712
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GlasgowUnited KingdomUnknown status
Barts Health NHS Trust /ID# 161053
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LondonUnited KingdomUnknown status
Guys and St Thomas NHS Foundation Trust /ID# 161063
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LondonUnited KingdomUnknown status
Duplicate_Bedfordshire Hospitals NHS Foundation Trust /ID# 162713
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LutonUnited KingdomUnknown status
Duplicate_Christchurch University Hospitals Dorset NHS University Hospitals Dors /ID# 162711
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PooleUnited KingdomUnknown status
General Hospital of Athens Laiko /ID# 163474
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AthensGreeceUnknown status
Naval Hospital of Athens /ID# 163495
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AthensGreeceUnknown status
Reg Gen Univ Hosp Larissa /ID# 163493
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LarissaGreeceUnknown status
Revita Reumatologiai Rendelo /ID# 162575
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BudapestHungaryUnknown status
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 170911
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BudapestHungaryUnknown status
Obudai Egeszsegugyi Centrum Kft. /ID# 162576
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BudapestHungaryUnknown status
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 162572
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DebrecenHungaryUnknown status
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 162573
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GyőrHungaryUnknown status
MÁV Kórház /ID# 162574
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SzolnokHungaryUnknown status
Vital Medicina Kft /ID# 162571
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VeszprémHungaryUnknown status
Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 162748
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AnconaItalyUnknown status
Duplicate_A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 164126
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CataniaItalyUnknown status
Duplicate_AOU Arcispedale Sant Anna di /ID# 164127
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ConaItalyUnknown status
ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 164125
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MilanItalyUnknown status
Azienda Ospedaliera Universitaria Federico II /ID# 202410
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NaplesItalyUnknown status
Duplicate_Azienda Unita Sanitaria Locale/IRCCS /ID# 162751
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Reggio EmiliaItalyUnknown status
Duplicate_Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 164123
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RomeItalyUnknown status
Duplicate_Fondazione PTV Policlinico Tor Vergata /ID# 162749
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RomeItalyUnknown status
Asahikawa Medical University Hospital /ID# 200684
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Asahikawa-shiJapanUnknown status
Juntendo University Hospital /ID# 162089
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Bunkyo-kuJapanUnknown status
St.Luke's International Hospital /ID# 162013
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Chuo-kuJapanUnknown status
Fukuoka University Hospital /ID# 161774
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FukuokaJapanUnknown status
Kansai Medical University Hospital /ID# 162081
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Hirakata-shiJapanUnknown status
National Hospital Organization Osaka Minami Medical Center /ID# 162589
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Kawachinagano ShiJapanUnknown status
Duplicate_Kitakyushu Municipal Medical Center /ID# 163516
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Kitakyushu-shiJapanUnknown status
Hospital of the University of Occupational and Environmental Health, Japan /ID# 161472
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Kitakyushu-shiJapanUnknown status
Daido Hospital /ID# 163639
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NagoyaJapanUnknown status
Nagoya City University Hospital /ID# 162563
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NagoyaJapanUnknown status
Oribe Clinic of Rheumatism and Medicine /ID# 163704
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ŌitaJapanUnknown status
Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773
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OsakaJapanUnknown status
Osaka Metropolitan University Hospital /ID# 162082
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OsakaJapanUnknown status
Tohoku University Hospital /ID# 164035
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SendaiJapanUnknown status
Keio University Hospital /ID# 162130
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Shinjuku-kuJapanUnknown status
Mie University Hospital /ID# 162085
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TsuJapanUnknown status
Duplicate_Inha University Hospital /ID# 163892
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JungguSouth KoreaUnknown status
Duplicate_Ajou University Hospital /ID# 163893
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SuwonSouth KoreaUnknown status
Medisch Centrum Leeuwarden /ID# 163049
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LeeuwardenNetherlandsUnknown status
Maasstad Ziekenhuis /ID# 163050
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RotterdamNetherlandsUnknown status
Duplicate_Erasmus Medisch Centrum /ID# 163052
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RotterdamNetherlandsUnknown status
Sint Maartenskliniek /ID# 163703
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UbbergenNetherlandsUnknown status
Waikato Hospital /ID# 166412
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HamiltonNew ZealandUnknown status
Porter Rheumatology Ltd /ID# 200422
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NelsonNew ZealandUnknown status
Duplicate_Middlemore Hospital /ID# 166411
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OtahuhuNew ZealandUnknown status
Timaru Medical Specialists Ltd /ID# 166410
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TimaruNew ZealandUnknown status
Alma M. Cruz Santana, MD-Private practice /ID# 163308
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CarolinaPuerto RicoUnknown status
Ponce Medical School Foundation /ID# 163918
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PoncePuerto RicoUnknown status
GCM Medical Group PSC /ID# 163716
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San JuanPuerto RicoUnknown status
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 165896
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LisbonPortugalUnknown status
Instituto Portugues De Reumatologia /ID# 165894
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LisbonPortugalUnknown status
Unidade Local de Saude de Santa Maria, EPE /ID# 165895
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LisbonPortugalUnknown status
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 165898
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Ponte de LimaPortugalUnknown status
Duplicate_Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 165897
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Vila Nova de GaiaPortugalUnknown status
Center for Rheumatology LLP /ID# 167046
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AlbanyUnited StatesUnknown status
Arthritis Clinic of N. VA, P.C /ID# 159858
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ArlingtonUnited StatesUnknown status
Tekton Research, Inc. /ID# 160008
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AustinUnited StatesUnknown status
Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 161409
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AventuraUnited StatesUnknown status
Diagnostic Group /ID# 161406
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BeaumontUnited StatesUnknown status
Osteoporosis Medical Center /ID# 161411
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Beverly HillsUnited StatesUnknown status
DJL Clinical Research, PLLC /ID# 161414
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CharlotteUnited StatesUnknown status
Great Lakes Clinical Trials /ID# 163438
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ChicagoUnited StatesUnknown status
Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 163439
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College StationUnited StatesUnknown status
Adriana Pop-Moody MD Clinic PA /ID# 160009
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Corpus ChristiUnited StatesUnknown status
Covina Arthritis Clinic /ID# 159919
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CovinaUnited StatesUnknown status
Metroplex Clinical Research /ID# 159818
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DallasUnited StatesUnknown status
International Medical Research /ID# 160051
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Daytona BeachUnited StatesUnknown status
Jefrey D. Lieberman, MD, P.C. /ID# 159842
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DecaturUnited StatesUnknown status
Denver Arthritis Clinic /ID# 159899
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DenverUnited StatesUnknown status
Altoona Ctr Clinical Res /ID# 159861
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DuncansvilleUnited StatesUnknown status
Triwest Research Associates /ID# 159915
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El CajonUnited StatesUnknown status
Arthritis Treatment Center /ID# 160053
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FrederickUnited StatesUnknown status
Duplicate_Providence Medical Foundation /ID# 160005
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FullertonUnited StatesUnknown status
Physicians East, PA /ID# 159898
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GreenvilleUnited StatesUnknown status
C.V. Mehta MD, Med Corporation /ID# 161192
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HemetUnited StatesUnknown status
Accurate Clinical Research /ID# 160052
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HoustonUnited StatesUnknown status
Rheumatic Disease Clin Res Ctr /ID# 161252
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HoustonUnited StatesUnknown status
Care Access Research, Huntington Beach /ID# 160049
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Huntington BeachUnited StatesUnknown status
Rheumatology Consultants, PLLC /ID# 161408
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KnoxvilleUnited StatesUnknown status
Colorado Arthritis Associates /ID# 159856
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LakewoodUnited StatesUnknown status
Purushotham & Akther Kotha MD, Inc /ID# 159834
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La MesaUnited StatesUnknown status
Duplicate_Arthritis and Osteo Assoc /ID# 160015
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Las CrucesUnited StatesUnknown status
Deerbrook Medical Associates /ID# 159815
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LibertyvilleUnited StatesUnknown status
P&I Clinical Research /ID# 159837
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LufkinUnited StatesUnknown status
Atlanta Research Center for Rheumatology /ID# 161201
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MariettaUnited StatesUnknown status
Dr. Ramesh Gupta /ID# 160067
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MemphisUnited StatesUnknown status
Velocity Clinical Research - Boise /ID# 159922
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MeridianUnited StatesUnknown status
Arizona Arthritis & Rheumatology Research, PLLC /ID# 160047
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MesaUnited StatesUnknown status
SW Rheumatology Res. LLC /ID# 160014
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MesquiteUnited StatesUnknown status
Precision Research Organization /ID# 161293
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Miami LakesUnited StatesUnknown status
Trinity Health Med Arts Clinic /ID# 159811
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MinotUnited StatesUnknown status
Alabama Medical Group, PC /ID# 159836
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MobileUnited StatesUnknown status
The Arthritis & Diabetes Clinic, Inc. /ID# 161294
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MonroeUnited StatesUnknown status
Duplicate_Suncoast Clinical Research /ID# 161417
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New Port RicheyUnited StatesUnknown status
Health Research of Oklahoma /ID# 159913
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Oklahoma CityUnited StatesUnknown status
Westroads Clinical Research /ID# 160004
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OmahaUnited StatesUnknown status
Millennium Research /ID# 159833
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Ormond BeachUnited StatesUnknown status
Arthritis Center, Inc. /ID# 163463
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Palm HarborUnited StatesUnknown status
Gulf Region Clinical Res Inst /ID# 159860
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PensacolaUnited StatesUnknown status
Sun Valley Arthritis Center Ltd. /ID# 161203
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PeoriaUnited StatesUnknown status
Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 160006
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PhoenixUnited StatesUnknown status
University of Pittsburgh MC /ID# 161193
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PittsburghUnited StatesUnknown status
St. Lawrence Health System /ID# 159857
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PotsdamUnited StatesUnknown status
Shanahan Rheuma & Immuno /ID# 160012
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RaleighUnited StatesUnknown status
Sarasota Arthritis Center /ID# 159854
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SarasotaUnited StatesUnknown status
Duplicate_Swedish Medical Center /ID# 159918
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SeattleUnited StatesUnknown status
Duplicate_Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 160068
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SkokieUnited StatesUnknown status
Clinvest Research LLC /ID# 161208
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SpringfieldUnited StatesUnknown status
Stanford University School of Med /ID# 161402
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StanfordUnited StatesUnknown status
BayCare Medical Group /ID# 161405
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St. PetersburgUnited StatesUnknown status
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462
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SummervilleUnited StatesUnknown status
West Broward Rheumatology Associates /ID# 161412
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TamaracUnited StatesUnknown status
BayCare Medical Group, Inc. /ID# 159912
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TampaUnited StatesUnknown status
USF Health Morsani Center for /ID# 161291
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TampaUnited StatesUnknown status
Clinical Research of West Florida, Inc /ID# 159840
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TampaUnited StatesUnknown status
Clinical Research of West Florida - Tampa /ID# 160069
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TampaUnited StatesUnknown status
DM Clinical Research - Tomball /ID# 161753
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TomballUnited StatesUnknown status
Atlantic Coast Research /ID# 159810
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Toms RiverUnited StatesUnknown status
Inland Rheum Clin Trials Inc. /ID# 159839
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UplandUnited StatesUnknown status
STAT Research, Inc. /ID# 161416
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VandaliaUnited StatesUnknown status
Arthritis & Osteoporosis Clinic /ID# 161400
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WacoUnited StatesUnknown status
The Center for Rheumatology and Bone Research /ID# 159900
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WheatonUnited StatesUnknown status
Medvin Clinical Research /ID# 160045
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WhittierUnited StatesUnknown status
PMG Research of Wilmington LLC /ID# 161403
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WilmingtonUnited StatesUnknown status
Clinical Pharmacology Study Group /ID# 158712
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WorcesterUnited StatesUnknown status
Florida Medical Clinic /ID# 160013
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ZephyrhillsUnited StatesUnknown status

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