A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease (STAR)
Last Updated   April 24, 2024 - 21:02
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 4These studies are conducted after a drug or treatment is approved for use by regulatory authorities. Phase 4 studies gather additional information on the drug's effects and side effects. -
Sites
sites -
Status
Recruiting
SUMMARY
PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin (Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production. This study will consist of a screening phase (up to 6 weeks), a treatment phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up phase (up to Week 60). The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments will include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events. The overall duration of the study will be up to 14 months.
CONDITIONS
- Arthritis, Psoriatic
ELIGIBILITY
Inclusion Criteria:
* Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening
* Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
* Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac [SI] joints, shown by a Spondyloarthritis Research Consortium of Canada [SPARCC] score of >= 3 in either the spine or the sacroiliac joints)
* Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4
* Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
Exclusion Criteria:
* Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
* Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
* Has previously received any biologic treatment
* Has ever received a Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor
* Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
DETAILS
PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin (Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production. This study will consist of a screening phase (up to 6 weeks), a treatment phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up phase (up to Week 60). The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments will include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events. The overall duration of the study will be up to 14 months.
LOCATIONS
Country (26) | City or Province (223) | Status |
United States | Amarillo, TX Amarillo Center for Clinical Research |
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United States | Austin, TX Austin Regional Clinic |
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United States | Bay Pines, FL Bay Pines VA Healthcare System |
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United States | Chandler, AZ Arizona Arthritis & Rheumatology Research, PLLC |
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United States | Chicago, IL Great Lakes Clinical Trials |
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United States | Colleyville, TX Precision Comprehensive Clinical Research Solutions |
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United States | Corpus Christi, TX Adriana Pop Moody MD Clinic PA |
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United States | Danbury, CT Clinical Research Center of Connecticut |
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United States | Eagan, MN St. Paul Rhuematology P A |
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United States | Hagerstown, MD Klein And Associates M D P A |
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United States | Hinsdale, IL RC Research |
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United States | Houston, TX UT Physicians Center for Autoimmunity |
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United States | Huntington Beach, CA Newport Huntington Medical Group |
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United States | Lubbock, TX West Texas Clinical Research |
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United States | Mesa, AZ Arizona Arthritis and Rheumatology Research PLLC |
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United States | Mesquite, TX Southwest Rheumatology Research LLC |
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United States | Phoenix, AZ Arizona Arthritis Research, PLC. |
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United States | Phoenix, AZ Arizona Arthritis and Rheumatology Research PLLC |
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United States | Plantation, FL Integral Rheumatology And Immunology Specialists |
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United States | Portland, OR OHSU Rheumatology Clinic, Marquam Hill |
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United States | Red Oak, TX Epic Medical Research |
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United States | Rockford, IL OrthoIllinois |
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United States | Saint Clair Shores, MI Clinical Research Institute of Michigan, LLC |
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United States | Searcy, AR Unity Health-White County Medical Center |
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United States | Seattle, WA Swedish Medical Center |
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United States | Springfield, MO Clinvest |
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United States | Sun City, AZ Arizona Arthritis and Rheumatology Associates |
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United States | Tomball, TX DM Clinical Research |
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United States | Tucson, AZ Southern Arizona VA Healthcare System |
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United States | Vandalia, OH STAT Research, Inc. |
COMPLETED
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United States | Zephyrhills, FL Florida Medical Clinic, P.A. |
COMPLETED
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United Kingdom | Barnet Royal Free London NHS Foundation Trust |
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United Kingdom | Bradford, WYK St. Lukes Hospital |
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United Kingdom | Coventry, WMD University Hospital Coventry & Warwickshire NHS Trust |
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United Kingdom | Leeds, WYK Chapel Allerton Hospital |
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United Kingdom | Manchester Central Manchester University Hospitals NHS Foundation Trust |
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United Kingdom | Newcastle North Tyneside General Hospital |
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United Kingdom | Stoke on Trent Haywood Hospital |
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Ukraine | Cherkasy Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council |
TERMINATED
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Ukraine | Kharkiv Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital |
COMPLETED
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Ukraine | Khmelnytsky Khmelnitckiy regional hospital |
TERMINATED
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Ukraine | Kryvyi Rih City Clinical Hospital No. 2 |
TERMINATED
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Ukraine | Kyiv Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway' |
COMPLETED
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Ukraine | Kyiv Medical Center of 'Institute of Rheumatology', LLC |
TERMINATED
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Ukraine | Kyiv SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine |
COMPLETED
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Ukraine | Lutsk Volyn Regional Clinical Hospital |
COMPLETED
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Ukraine | Odessa Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council |
TERMINATED
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Ukraine | Poltava ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil |
TERMINATED
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Ukraine | Ternopil Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital' |
COMPLETED
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Ukraine | Vinnytsia Health Clinic Limited Liability Company |
TERMINATED
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Ukraine | Zaporizhzhya Medical Center LLC 'Modern Clinic' |
TERMINATED
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Turkey | Adana Adana City Hospital |
RECRUITING
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Turkey | Ankara Ankara Bilkent City Hospital |
COMPLETED
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Turkey | Ankara Gulhane Training and Research Hospital |
RECRUITING
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Turkey | Ankara Hacettepe University Medical Faculty |
COMPLETED
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Turkey | Antalya Akdeniz University Medical Faculty |
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Turkey | Bursa Uludag University Medical Faculty |
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Turkey | Istanbul Istanbul University Cerrahpasa Medical Faculty |
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Turkey | Istanbul Marmara University Medical Faculty |
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Turkey | Konya Necmettin Erbakan University Meram Medical Faculty |
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Thailand | Bangkok, 10 Phramongkutklao Hospital and Medical College |
RECRUITING
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Thailand | Bangkok, 10 Ramathibodi Hospital, Mahidol University |
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Thailand | Chiangmai, 50 Chiang Mai University |
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Taiwan | Hsin Chu National Taiwan University Hospital |
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Taiwan | Tainan National Cheng Kung University Hospital |
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Taiwan | Taoyuan Linkou Chang Gung Memorial Hospital |
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Sweden | Solna Karolinska Universitetssjukhuset |
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Sweden | Uppsala Akademiska Sjukhuset |
RECRUITING
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Spain | A Coruna Hosp. Univ. A Coruna |
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Spain | Barakaldo Hosp. Univ. de Cruces |
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Spain | Barcelona, BA Hosp. Clinic de Barcelona |
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Spain | Bilbao Hosp. Univ. de Basurto |
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Spain | Cordoba Hosp. Reina Sofia |
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Spain | Madrid, MD Hosp. Clinico San Carlos |
COMPLETED
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Spain | Málaga Hosp. Regional Univ. de Malaga |
RECRUITING
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Spain | Sabadell, BA Corporacio Sanitari Parc Tauli |
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Spain | Santiago de Compostela Clinica Gaias |
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Spain | Sevilla Hosp. Quiron Sagrado Corazon |
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Spain | Sevilla Hosp. Virgen Macarena |
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Spain | Valencia, VC Hosp. Univ. I Politecni La Fe |
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Slovakia | Martin Reumatologicka ambulancia |
RECRUITING
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Slovakia | Nove Mesto nad Vahom Reumatologicka ambulancia |
RECRUITING
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Slovakia | Piestany Reumatologická ambulancia Thermium s.r.o. |
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Slovakia | Poprad REUMAMED POPRAD, s.r.o. |
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Slovakia | Rimavska Sobota Reumex s.r.o |
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Russia | Barnaul Altay Medical State University |
COMPLETED
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Russia | Chelyabinsk Chelyabinck Regional Clinical Hospital |
TERMINATED
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Russia | Chelyabinsk Chelyabinsk Regional Clinical Dermatovenerological Dispensary |
COMPLETED
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Russia | Ekaterinbourg Sverdlovsk Regional Clinical Hospital N. 1 |
TERMINATED
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Russia | Izhevsk Regional Clinical Diagnostic Center of Udmurtia Region |
COMPLETED
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Russia | Kemerovo LLL Medical Center Revma-Med |
COMPLETED
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Russia | Korolev LLC Family Outpatient Clinic # 4 |
COMPLETED
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Russia | Krasnoyarsk Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon |
TERMINATED
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Russia | Moscow Clinical-Diagnostic Center Euromedservice, JSC |
COMPLETED
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Russia | Moscow FGBU Research Institute of Rheumatology named V.A.Nasonova |
COMPLETED
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Russia | Moscow GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi' |
COMPLETED
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Russia | Omsk Llc Ultramed |
COMPLETED
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Russia | Orenburg GBOU VPO Orenburg State Medical University |
TERMINATED
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Russia | Perm GBUZ Perm Regional Clinical Hospital |
TERMINATED
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Russia | Petrozavodsk Republican Hospital n.a.V.A.Baranov |
COMPLETED
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Russia | Rostov Rostov Regional Clinical Dermatovenerological Dispensary |
COMPLETED
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Russia | St. Petersburg St. Petersburg GBUZ Clinical Reumatological Hospital 25 |
COMPLETED
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Russia | St. Petersburg X7 Clinical Research Company Limited |
TERMINATED
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Russia | Tolyatti GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5' |
COMPLETED
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Russia | Ufa Republican Clinical Hospital - G.G. Kuvatov |
COMPLETED
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Russia | Yaroslavl Clinical Hospital #3 |
COMPLETED
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Portugal | Braga, Braga Ccab - Hosp. de Braga |
RECRUITING
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Portugal | Guarda Ulsg - Hosp. Sousa Martins |
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Portugal | Lisboa Chln - Hosp. Santa Maria |
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Portugal | Lisboa Chlo Hosp Egas Moniz |
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Portugal | Lisboa Hospital CUF Tejo |
COMPLETED
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Portugal | Lisboa Ipr - Inst. Port. de Reumatologia |
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Portugal | Ponte de Lima Ulsam - Hosp. Conde de Bertiandos |
RECRUITING
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Portugal | Porto Chsj - Hosp. Sao Joao |
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Poland | Bialystok ClinicMed Daniluk Nowak Spolka Komandytowa |
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Poland | Bydgoszcz Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy |
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Poland | Bytom Nzoz Bif Med |
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Poland | Elblag Ambulatorium sp. z o.o. |
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Poland | Elblag Centrum Kliniczno Badawcze |
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Poland | Krakow Centrum Medyczne Promed |
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Poland | Krakow Malopolskie Badania Kliniczne Sp z o o |
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Poland | Lodz Centrum Medyczne AMED oddzial w Lodzi |
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Poland | Lodz Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna |
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Poland | Lodz Dermed Centrum Medyczne Sp z o o |
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Poland | Lublin KO-MED Centra Kliniczne LUBLIN |
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Poland | Lublin Pro Life Medica Sp. z o.o. |
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Poland | Nadarzyn NZOZ Lecznica MAK MED S C |
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Poland | Nowa Sol Twoja Przychodnia - Centrum Medyczne Nowa Sol |
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Poland | Poznan Reumedika s c Wieslawa Porawska Lukasz Porawski |
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Poland | Poznan Twoja Przychodnia Poznanskie Centrum Medyczne |
RECRUITING
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Poland | Swidnik Lubelskie Centrum Diagnostyczne |
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Poland | Torun MICS Centrum Medyczne Torun |
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Poland | Warsaw MICS Centrum Medyczne Warszawa |
RECRUITING
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Poland | Warsaw Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher |
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Poland | Warszawa Centrum Medyczne AMED Targowek |
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Poland | Warszawa Centrum Medyczne Reuma Park |
RECRUITING
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Poland | Warszawa ETG Warszawa |
COMPLETED
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Poland | Warszawa Rheuma-Medicus Sp. z o.o. |
RECRUITING
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Poland | Wrocław WroMedica I.Bielicka, A.Strzałkowska s.c. |
RECRUITING
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Philippines | Cebu City, CEB Cebu Doctors' University Hospital |
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Philippines | Davao City, DSU Davao Doctors Hospital |
RECRUITING
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Philippines | Lipa, BTG Lipa Medix Medical Hospital |
RECRUITING
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Philippines | Manila ManilaMed Medical Center Manila |
RECRUITING
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Philippines | San Fernando, PMP Ilocos Training and Regional Medical Center |
RECRUITING
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Malaysia | Batu Caves, SL Hospital Selayang |
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Malaysia | George Town Hospital Pulau Pinang |
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Malaysia | Johor Bahru, JH Hospital Sultan Ismail |
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Malaysia | Kuala Lumpur University Malaya Medical Centre |
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Malaysia | Seremban, NS Hospital Tuanku Jaafar |
RECRUITING
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Italy | Ancona A.O. Universitaria Ospedali Riuniti di Ancona |
RECRUITING
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Italy | Monserrato Azienda Ospedaliero-Universitaria di Cagliari |
RECRUITING
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Italy | Reggio Emilia Arcispedale Santa Maria Nuova - IRCCS |
RECRUITING
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Italy | Roma Policlinico Tor Vergata |
RECRUITING
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Italy | Rozzano (MI) Humanitas Hospital |
RECRUITING
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Italy | Verona Azienda Ospedaliera Universitaria Integrata Verona |
RECRUITING
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Israel | Haifa, H Bnai Zion Medical Center |
RECRUITING
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Israel | Hifa, H Carmel Medical Center |
RECRUITING
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Israel | Kfar-Sava Meir Medical Center |
COMPLETED
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Israel | Ramat Gan Sheba Medical Center |
RECRUITING
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Hungary | Budapest Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz |
RECRUITING
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Hungary | Budapest Obudai Egeszsegugyi Centrum Kft |
RECRUITING
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Hungary | Budapest Qualiclinic Kft |
RECRUITING
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Hungary | Gyula Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz |
RECRUITING
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Hungary | Kistarcsa Kistarcsai Flor Ferenc Korhaz |
RECRUITING
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Hungary | Székesfehérvár Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz |
RECRUITING
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Hungary | Veszprem Vital Medical Center Orvosi es Fogaszati Kozpont |
RECRUITING
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Hong Kong | Hong Kong Prince Of Wales Hospital |
RECRUITING
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Germany | Berlin, BE ISA - Interdisciplinary Study Association GmbH |
RECRUITING
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Germany | Hamburg, HH Hamburger Rheuma Forschungszentrum II |
COMPLETED
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Germany | Herne, NW Rheumazentrum Ruhrgebiet |
RECRUITING
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Germany | Ratingen Rheumazentrum Ratingen |
COMPLETED
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Georgia | Kutaisi, IM LTD Clinic LJ |
RECRUITING
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Georgia | T'bilisi, TB Clinic on Mtskheta Street |
RECRUITING
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Georgia | T'bilisi, TB LTD 'Aversi Clinic' |
RECRUITING
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Georgia | T'bilisi, TB Ltd American Hospital Network |
RECRUITING
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Georgia | T'bilisi, TB Tbilisi Heart and Vascular Clinic Ltd |
RECRUITING
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Georgia | Tbilisi, TB Aleksandre Aladashvili Clinic LLC |
RECRUITING
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Georgia | Tbilisi, TB Consilium Medulla-multiprofile clinic Ltd |
RECRUITING
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Georgia | Tbilisi, TB LTD Helsicore |
RECRUITING
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Georgia | Tbilisi, TB LTD MediClub Georgia |
RECRUITING
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Georgia | Tbilisi, TB LTD The First Medical Center |
RECRUITING
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Georgia | Tbilisi, TB Ltd New Hospitals |
RECRUITING
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Georgia | Tbilisi, TB TSMU The First University Clinic |
RECRUITING
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Georgia | Tnilisi, TB JSC Evex Hospitals |
RECRUITING
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Denmark | Frederiksberg Frederiksberg Hospital |
RECRUITING
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Denmark | Glostrup Rigshospitalet Glostrup |
RECRUITING
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Denmark | Køge Køge Sygehus Region Sjaelland |
RECRUITING
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Denmark | Vejle Vejle Sygehus |
RECRUITING
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Czechia | Brno Revmaclinic |
COMPLETED
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Czechia | Brno Revmatologie s r o |
COMPLETED
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Czechia | Brno Zidenice Revmacentrum MUDr Mostera s r o |
RECRUITING
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Czechia | Hlucin L K N Arthrocentrum |
RECRUITING
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Czechia | Ostrava MUDr Rosypalova s r o |
RECRUITING
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Czechia | Pardubice Arthrohelp S.R.O. |
RECRUITING
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Czechia | Praha Revmatologicky ustav |
RECRUITING
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Czechia | Uherske Hradiste Medical Plus S R O |
RECRUITING
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Canada | Quebec, QC G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. |
RECRUITING
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Canada | St. John's, NL Eastern Regional Health Authority, St. Clare's Mercy Hospital |
RECRUITING
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Canada | Toronto, ON Toronto Western Hospital |
RECRUITING
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Canada | Vancouver, BC Skin Care Centre |
RECRUITING
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Bulgaria | Pleven Exacta Medica |
RECRUITING
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Bulgaria | Pleven UMHAT 'Dr. Georgi Stranski', EAD |
RECRUITING
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Bulgaria | Plovdiv Medical Center Artmed |
RECRUITING
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Bulgaria | Plovdiv Medical Center Unimed Plovdiv |
RECRUITING
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Bulgaria | Plovdiv UMHAT Kaspela |
RECRUITING
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Bulgaria | Sfia UMHAT St. Ivan Rilski |
RECRUITING
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Bulgaria | Sofia ASIMP Rheumatology Centre St Irina EOOD |
RECRUITING
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Bulgaria | Sofia DCC Convex EOOD |
RECRUITING
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Bulgaria | Sofia MHAT 'Lyulin' EAD |
RECRUITING
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Bulgaria | Sofia Medical Centre Synexus |
RECRUITING
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Bulgaria | Sofia Military Medical Academy |
RECRUITING
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Bulgaria | Sofia University Multiprofile Hospital Sofiamed Sofia |
COMPLETED
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Bulgaria | Targovishte DDC Sv. Ivan Rilski OOD |
RECRUITING
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Australia | Camberwell, VIC Emeritus Research |
COMPLETED
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Australia | Hobart, TAS Southern Clinical Research |
RECRUITING
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Australia | Liverpool, NSW Liverpool Hospital |
COMPLETED
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Australia | Maroochydore, QLD Rheumatology Research Unit |
TERMINATED
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Australia | Melbourne, VIC Eastern Health - Box Hill Hospital |
COMPLETED
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Australia | Melbourne, VIC Skin Health Institute Inc. |
TERMINATED
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Argentina | Buenos Aires, B Centro Privado de Medicina Familiar |
RECRUITING
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Argentina | Buenos Aires, B Cosultorios Reumatologógicos Pampa |
RECRUITING
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Argentina | Buenos Aires, B Hospital Italiano de Buenos Aires |
RECRUITING
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Argentina | La Plata Hospital Italiano La Plata |
RECRUITING
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