A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice (PsABIOnd)
Last Updated   April 24, 2024 - 21:10
OVERVIEW
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Gender
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Age
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Phase
phase -
Sites
sites -
Status
Recruiting
SUMMARY
Psoriatic arthritis (PsA) is a seronegative inflammatory spondylarthritis associated with psoriasis (PsO), which can cause pain and swelling in the joints, sausage-shaped swelling of the fingers and toes (dactylitis), inflammation of the muscle- or tendon insertions at adjacent bone (enthesitis), as well as raised red patches or various other expressions of psoriasis on the skin. Guselkumab (TREMFYA) is a fully human immunoglobulin G1 lambda (IgG1) monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL) 23 with high specificity and affinity, blocking IL-23 binding. Binding of guselkumab to the IL-23p19 subunit blocks the subsequent binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling and subsequent activation and cytokine production. Participants with confirmed diagnosis of PsA who are starting guselkumab or any marketed interleukin-17 inhibitor (IL-17i) as a first, second, third, or fourth line of PsA biologic therapy per standard clinical practice will be enrolled in the main study. The aim of main study is to document the use of guselkumab and approved IL-17i therapies in routine clinical practice in patients with PsA who are starting guselkumab or an IL-17i as a first, second, third, or fourth line of biologic disease-modifying antirheumatic drugs (bDMARD) therapy. The overall duration of the main study, including recruitment and follow-up, is expected to be about 6 years. Participants who are starting guselkumab or an IL-17i treatment per routine clinical practice in the main study, and who meet the selection criteria for both the main study and substudy, will be consecutively offered entry into the substudy (a select number) at the time of enrollment into the main study. The substudy aims to collect additional data, continuously or with increased frequency, on the impact of guselkumab or IL-17i on patient mood, physical activity, sleep disturbance, disease symptoms, and health-related quality-of-life (HRQoL). Total duration of the substudy will be approximately 26-30 weeks consisting of a pre-treatment period of up to 14 days before the first dose of guselkumab or IL-17i in the main study and a 24-week (plus [+] up to 4 weeks follow-up) observation period.
CONDITIONS
- Arthritis, Psoriatic
ELIGIBILITY
Inclusion Criteria:
Main study:* Have a confirmed diagnosis of PsA as determined by a rheumatologist with reference to Classification criteria for Psoriatic Arthritis (CASPAR)
* Start guselkumab or any approved interleukin-17 inhibitor (IL-17i) as a first, second, third, or fourth line of biologic disease-modifying antirheumatic drugs (bDMARD) therapy for the indication of PsA as part of standard clinical practice (according to local label, local regulations, and/or reimbursement requirements) at the time of enrollment into the observational study or within a maximum of 2 months after the initial baseline visit or after repeated baseline data collection
* Sign a participation agreement/Informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
* Able to read, understand, and intend to comply with completion of all Electronic patient-reported outcome (ePRO) instruments
* The treatment decision must be taken by the participating rheumatologist prior to, and independently of the participant's inclusion into the study, following clinical practice in accordance with local and overarching guidelines and local regulationsSubstudy:* Must sign the substudy ICF allowing data collection in accordance with local requirements
* Is scheduled to receive guselkumab or IL-17i, per routine clinical practice, in the main study
* Currently using or is willing to use wearables and/or commercial applications to track their disease within the course of their normal daily activities
Exclusion Criteria:
Main study:* Start guselkumab or an IL-17i therapy as fifth or further line of biologic treatment
* Have already taken a specific IL-17i or IL-23i treatment and are planning on re-taking that specific treatment again
* Unwilling or unable to participate in long-term data collection
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study (that is, signing of informed consent)
* Currently enrolled in any interventional study or any Janssen-sponsored observational clinical study (contemporary participation into observational studies or registries not sponsored by Janssen is acceptable)Substudy:* Have an insufficient command of language to interact effectively with the smartphone application, in the opinion of the investigator at each site
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (example, compromise the well-being) or that could prevent, limit, or confound assessment
* Unwilling or unable to comply with substudy assessments
DETAILS
Psoriatic arthritis (PsA) is a seronegative inflammatory spondylarthritis associated with psoriasis (PsO), which can cause pain and swelling in the joints, sausage-shaped swelling of the fingers and toes (dactylitis), inflammation of the muscle- or tendon insertions at adjacent bone (enthesitis), as well as raised red patches or various other expressions of psoriasis on the skin. Guselkumab (TREMFYA) is a fully human immunoglobulin G1 lambda (IgG1) monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL) 23 with high specificity and affinity, blocking IL-23 binding. Binding of guselkumab to the IL-23p19 subunit blocks the subsequent binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling and subsequent activation and cytokine production. Participants with confirmed diagnosis of PsA who are starting guselkumab or any marketed interleukin-17 inhibitor (IL-17i) as a first, second, third, or fourth line of PsA biologic therapy per standard clinical practice will be enrolled in the main study. The aim of main study is to document the use of guselkumab and approved IL-17i therapies in routine clinical practice in patients with PsA who are starting guselkumab or an IL-17i as a first, second, third, or fourth line of biologic disease-modifying antirheumatic drugs (bDMARD) therapy. The overall duration of the main study, including recruitment and follow-up, is expected to be about 6 years. Participants who are starting guselkumab or an IL-17i treatment per routine clinical practice in the main study, and who meet the selection criteria for both the main study and substudy, will be consecutively offered entry into the substudy (a select number) at the time of enrollment into the main study. The substudy aims to collect additional data, continuously or with increased frequency, on the impact of guselkumab or IL-17i on patient mood, physical activity, sleep disturbance, disease symptoms, and health-related quality-of-life (HRQoL). Total duration of the substudy will be approximately 26-30 weeks consisting of a pre-treatment period of up to 14 days before the first dose of guselkumab or IL-17i in the main study and a 24-week (plus \[+\] up to 4 weeks follow-up) observation period.
LOCATIONS
Country (20) | City or Province (154) | Status |
United Kingdom | Aberdeen NHS Grampian - Aberdeen Royal Infirmary (ARI) |
RECRUITING
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United Kingdom | Abergavenny, MON Nevill Hall Hospital |
RECRUITING
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United Kingdom | Airdrie University Hospital Monklands |
RECRUITING
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United Kingdom | Bath Wolfson Centre Royal United Hospitals |
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United Kingdom | Glasgow Glasgow Royal Infirmary |
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United Kingdom | Hull Hull Royal Infirmary |
RECRUITING
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United Kingdom | Leeds, WYK Chapel Allerton Hospital |
RECRUITING
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United Kingdom | London Kings College Hospital |
RECRUITING
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United Kingdom | Manchester Central Manchester University Hospitals NHS Foundation Trust |
RECRUITING
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United Kingdom | Newcastle Upon Tyne The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit |
RECRUITING
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United Kingdom | Portsmouth Queen Alexandra Hospital |
RECRUITING
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United Kingdom | Salford Shirley Caldwell |
RECRUITING
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United Kingdom | Southampton Southampton General Hospital |
RECRUITING
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United Kingdom | Staffordshire Haywood Hospital |
RECRUITING
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United Kingdom | Stamford, LIN Stamford and Rutland hospital |
RECRUITING
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United Kingdom | Wishaw Wishaw General |
RECRUITING
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Taiwan | Kaohsiung Chang Gung Medical Foundation |
RECRUITING
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Taiwan | Kaohsiung Kaohsiung Veterans General Hospital |
RECRUITING
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Taiwan | Taichung Taichung Veterans General Hospital |
RECRUITING
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Switzerland | Fribourg, FR HFR Fribourg - Hôpital Cantonal |
RECRUITING
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Sweden | Göteborg Sahlgrenska Universitetssjukhuset |
RECRUITING
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Sweden | Lund Universitetssjukhuset i Lund |
RECRUITING
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Sweden | Orebro Universitetssjukhuset Orebro |
RECRUITING
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Sweden | Stockholm Akademiskt Specialistcentrum centrum för reumatologi |
RECRUITING
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Sweden | Uppsala Akademiska Sjukhuset |
RECRUITING
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Spain | A Coruna Hosp. Univ. A Coruna |
RECRUITING
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Spain | Algeciras / Cadiz Hosp. Punta de Europa |
RECRUITING
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Spain | Barcelona, BA Hosp. Clinic de Barcelona |
RECRUITING
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Spain | Barcelona, BA Hosp. Univ. Vall D Hebron |
RECRUITING
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Spain | Bilbao Hosp. Univ. de Basurto |
RECRUITING
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Spain | Cordoba Hosp. Reina Sofia |
RECRUITING
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Spain | Granada, GD Complejo hospitalario de Granada |
RECRUITING
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Spain | Madrid, MD Hosp. Univ. 12 de Octubre |
RECRUITING
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Spain | Madrid, MD Hosp. Univ. de Getafe |
RECRUITING
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Spain | Oviedo, AS Hosp. Univ. Central de Asturias |
RECRUITING
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Spain | Santiago de Compostela Hosp. Clinico Univ. de Santiago |
RECRUITING
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Spain | Sevilla Hosp. Virgen Del Rocio |
RECRUITING
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South Korea | Cheonan-si, 44 Soonchunhyang University Cheonan Hospital |
RECRUITING
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South Korea | Seongnam, 41 Seoul National University Bundang Hospital |
COMPLETED
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South Korea | Seoul Seoul Metropolitan Government Seoul National University Boramae Medical Center |
RECRUITING
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South Korea | Seoul Seoul National University Hospital |
RECRUITING
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Russia | Kemerovo SBEU HPE Kemerovo State Medical Academy |
TERMINATED
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Russia | Moscow Bakoulev Scientific Center For Cardiovascular Surgery Rams |
TERMINATED
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Russia | Moscow FGBU Research Institute of Rheumatology named V.A.Nasonova |
COMPLETED
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Russia | Tomsk City Hospital #3 |
TERMINATED
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Netherlands | Amsterdam Academisch Medisch Centrum Universiteit van Amsterdam |
RECRUITING
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Netherlands | Enschede, OV Medisch Spectrum Twente |
RECRUITING
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Netherlands | Groningen, GR Universitair Medisch Centrum Groningen |
RECRUITING
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Netherlands | Helmond Elkerliek Ziekenhuis |
RECRUITING
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Mexico | Merida Medical Care & Research SA de CV |
RECRUITING
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Mexico | Mexico Consultorio de Reumatologia |
RECRUITING
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Mexico | Zapopan, JAL Hospital Puerta de Hierro |
RECRUITING
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Japan | Hyogo, 28 Kita-harima Medical Center |
RECRUITING
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Japan | Meguro-ku, 13 Toho University Medical Center, Ohashi Hospital |
RECRUITING
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Japan | Osaka, 27 Osaka Metropolitan University Hospital |
RECRUITING
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Japan | Osaka, 27 Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital |
RECRUITING
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Japan | Sapporo, 01 Hokkaido University Hospital |
RECRUITING
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Japan | Tokyo, 13 Kyorin University Hospital |
RECRUITING
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Italy | Bari Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari |
RECRUITING
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Italy | Campobasso Ospedale Regionale Cardarelli-Università degli Studi del Mol |
RECRUITING
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Italy | Catanzaro Universita della Magna grecia |
RECRUITING
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Italy | Firenze AOU Careggi |
RECRUITING
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Italy | Napoli Azienda Ospedaliera Universitaria Federico II |
RECRUITING
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Italy | Napoli Seconda Univesità degli Studi di Napoli, AOU |
RECRUITING
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Italy | Palermo Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone |
RECRUITING
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Italy | Pisa Azienda Ospedaliero Universitaria Pisana |
RECRUITING
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Italy | Potenza Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale |
RECRUITING
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Italy | Rome Universita Cattolica del Sacro Cuore |
RECRUITING
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Italy | Rozzano Istituto Clinico Humanitas |
RECRUITING
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Italy | Torino Azienda Ospedaliera Città della Salute e della Scienza di Torino |
RECRUITING
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Italy | Udine Azienda Ospedaliero Universitaria S.Maria Della Misericordia |
RECRUITING
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Italy | Verona Azienda Ospedaliera Universitaria Integrata Verona |
RECRUITING
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Greece | Athens Athens Navy Hospital |
RECRUITING
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Greece | Athens Evangelismos General Hospital of Athens |
RECRUITING
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Greece | Athens General Hospital 'Gennimatas' |
RECRUITING
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Greece | Athens Hippokration General Hospital of Athens, B' Internal Medicine Clinic, |
RECRUITING
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Greece | Athens Laiko General Hospital of Athens |
RECRUITING
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Greece | Ioannina University Hospital of Ioannina |
RECRUITING
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Greece | Patra 'Agios Andreas' General Hospital of Patras |
RECRUITING
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Greece | Patras University General Hospital of Rio Patras |
RECRUITING
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Greece | Thessaloniki Ippokrateio Hospital |
RECRUITING
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Germany | Amberg, BY Praxis für Rheumatologie |
RECRUITING
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Germany | Bayreuth Rheuma-Praxis Bayreuth |
RECRUITING
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Germany | Berlin, BE Rheumatologische Schwerpunktpraxis |
RECRUITING
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Germany | Berlin, BE Rheumatologische Schwerpunktpraxis |
RECRUITING
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Germany | Dusseldorf Universitätsklinikum Düsseldorf |
RECRUITING
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Germany | Erfurt, TH Service Rheuma Erfurt |
COMPLETED
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Germany | Frankfurt, HE Universitatsklinikum Frankfurt |
RECRUITING
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Germany | Halle-Saale, ST Rheumapraxis Dr. Liebhaber |
RECRUITING
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Germany | Hamburg, HH Praxis fur Klinische Studien und Praxis fur Orthopadie |
RECRUITING
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Germany | Hamburg, HH Rheumatologie im Struenseehaus |
RECRUITING
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Germany | Herne, NW Rheumazentrum Ruhrgebiet |
RECRUITING
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Germany | Koln Krankenhaus Porz am Rhein |
RECRUITING
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Germany | Leipzig Rheumatologische Praxis |
RECRUITING
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Germany | Magdeburg Rheumatologische Praxis |
RECRUITING
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Germany | München Praxiszentrum St. Bonifatius |
COMPLETED
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Germany | Neubrandenburg, MV Praxis Thilo Klopsch |
RECRUITING
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Germany | Püttlingen, SL Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie |
RECRUITING
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Germany | Ratingen Rheumazentrum Ratingen |
RECRUITING
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Germany | Templin, BB Rheumatologisch-immunologische Arztpraxis |
RECRUITING
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Germany | Vogelsang-Gommern, ST Immunologisches Zentrum Vogelsang-Gommern GmbH |
RECRUITING
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France | Bobigny Hôpital Avicenne |
RECRUITING
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France | Cholet Centre Hospitalier de Cholet |
RECRUITING
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France | Clermont Ferrand Hôpital Gabriel Montpied |
RECRUITING
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France | Creteil Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor |
RECRUITING
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France | Echirolles CHU Grenoble |
RECRUITING
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France | Lille CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur |
RECRUITING
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France | Lyon Centre Orthopedique Santy |
RECRUITING
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France | Lyon Clinique de l'Infirmerie Protestante de Lyon |
RECRUITING
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France | Nice Hôpital Saint Roch |
RECRUITING
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France | Orléans CHR Orléans - Nouvel Hôpital Orléans La Source |
RECRUITING
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France | Paris Hopital Saint-Antoine |
RECRUITING
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France | Paris Hôpital Bichat |
RECRUITING
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France | Paris Hôpital Lariboisière - Centre Viggo Petersen |
RECRUITING
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France | Paris Hôpital Pitié-Salpétrière |
RECRUITING
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France | Strasbourg Cedex CHRU Hôpital de Hautepierre |
RECRUITING
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France | Toulouse Hopital Purpan |
RECRUITING
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Colombia | Bogota BIOMAB |
RECRUITING
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Colombia | Bucaramanga, SAN Servimed S A S |
RECRUITING
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Colombia | Medellin, ANT Clinisalud del Sur |
RECRUITING
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Colombia | Montería, COR Funcentra |
RECRUITING
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Canada | Dundas, ON Private Practice - Dr. Pauline Boulos |
RECRUITING
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Canada | Markham, ON Markham Rheumatology Hub |
RECRUITING
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Canada | Mississauga, ON Brandusa Florica Medicine Professional Corporation |
RECRUITING
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Canada | Montreal, QC CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont |
RECRUITING
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Canada | Orillia, ON The Waterside Clinic |
RECRUITING
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Canada | Ottawa, ON The Ottawa Hospital Research Institute |
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 | Rimouski, QC Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski |
RECRUITING
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Canada | Saskatoon, SK Community Rheumatology Care |
RECRUITING
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Canada | Saskatoon, SK Rheumatology Associates of Saskatoon |
COMPLETED
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Canada | Sherbrooke, QC Centre Hospitalier Universitaire de Sherbrooke |
RECRUITING
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Canada | Sydney, NS Riverside Professional Center |
RECRUITING
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Canada | Trois Rivieres, QC Centre de Recherche Musculo Squelettique |
RECRUITING
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Canada | Vancouver, BC Artus Health Centre |
RECRUITING
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Canada | Windsor, ON Dr. Sabeen Anwar Medicine Professional Corporation |
RECRUITING
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Canada | Winnipeg, MB Manitoba Clinic |
RECRUITING
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Belgium | Brugge AZ Sint-Jan |
RECRUITING
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Belgium | Brussel, BRU Hopital Erasme |
RECRUITING
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Belgium | Genk, VLI Reumaclinic Genk-Hasselt |
RECRUITING
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Belgium | Leuven UZ Leuven |
RECRUITING
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Belgium | Liège CHU de Liège - Domaine Universitaire du Sart Tilman |
RECRUITING
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Austria | Graz LKH-Univ. Klinikum Graz |
RECRUITING
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Austria | Linz Kepler Universitätsklinikum GmbH |
COMPLETED
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Austria | Vienna Medizinische Universitat Wien |
RECRUITING
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Austria | Wien Evang. Krankenhaus Gemein. Betriebgesm. Mbh |
COMPLETED
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Australia | Adelaide, SA The Queen Elizabeth Hospital |
RECRUITING
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Australia | Footscray, VIC Footscray Hospital, Western Health |
RECRUITING
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Australia | St Leonards, NSW Royal North Shore Hospital |
RECRUITING
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Argentina | Buenos Aires, B Hospital Italiano de Buenos Aires |
RECRUITING
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Argentina | Buenos Aires, B Hospital J. M. Ramos Mejía |
RECRUITING
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Argentina | Ciudad Autónoma de Buenos Aires, B OMI |
COMPLETED
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Argentina | Córdoba, X Hospital Cordoba |
RECRUITING
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Argentina | San Fernando Buenos Aires MR Medicina Reumatologica |
RECRUITING
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