An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Study Purpose
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will enroll participants who completed the treatment periods of either one of the parent studies. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is:
- - How many participants have adverse events and serious adverse events? Researchers will also learn about the effect litifilimab has on controlling symptoms of SLE and lowering its activity.
- - The Week 52 visit of studies 230LE303 and 230LE304 will be Day 1 of this study.
- - Participants who were receiving either a high or low dose of litifilimab in the parent studies will continue receiving the same doses.
- - Participants who were receiving placebo in the parent studies will be randomized to receive either a high or low dose of litifilimab.
- - All participants will receive litifilimab as injections under the skin once every 4 weeks.
- - Neither the researchers nor the participants will know which doses of litifilimab the participants are receiving.
- - There will be a follow-up safety period that lasts up to 24 weeks.
- - In total, participants will have up to 47 study visits.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Key
Inclusion Criteria:
- - Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52.
Exclusion Criteria:
- - Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52) - Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period) - Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose) - Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05352919 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Biogen |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Medical Director |
| Principal Investigator Affiliation | Biogen |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Enrolling by invitation |
| Countries | Argentina, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Czechia, France, Greece, Hungary, Israel, Italy, Japan, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Serbia, South Korea, Spain, Taiwan, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Systemic Lupus Erythematosus (SLE) |
This is an extension study for all participants who completed study 230LE303 (NCT04895241) and 230LE304 (NCT04961567) (parent phase 3 studies) through Week 52 and did not discontinue litifilimab or placebo. Eligible participants from parent phase 3 studies will be followed for up to 180 weeks. The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE). The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.
Arms
Experimental: Litifilimab Low Dose
Participants who are receiving background nonbiologic lupus standard of care (SOC) therapy and received litifilimab low dose, subcutaneously (SC), every 4 weeks (Q4W) during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2.
Experimental: Litifilimab High Dose
Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab high dose, SC, Q4W during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2.
Interventions
Drug: - Litifilimab
Administered as specified in the treatment arm.
Drug: - Litifilimab-matching placebo
Administered as specified in the treatment arm.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix 5308655, Arizona 5551752, 85037
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Address
Wallace Rheumatic Study Center
Beverly Hills 5328041, California 5332921, 90211
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Address
Care Access Research - Huntington Beach
Huntington Beach 5358705, California 5332921, 92648
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Address
Providence Facey Medical Foundation
Mission Hills 5373650, California 5332921, 91345
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Address
Inland Rheumatology Clinical Trials, Inc.
Upland 5404915, California 5332921, 91786
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Address
University of Colorado Denver
Aurora 5412347, Colorado 5417618, 80045
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Address
Georgetown University Hospital-Medstar
Washington D.C. 4140963, District of Columbia 4138106, 20007-2113
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Address
Arthritis & Rheumatic Disease Specialties
Aventura 4146429, Florida 4155751, 33180
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Address
Clinical Research of West Florida - Corporate
Clearwater 4151316, Florida 4155751, 33765
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Address
GNP Research at Mark Jaffe, MD
Cooper City 4151824, Florida 4155751, 33024
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Address
Omega Research Consultants
DeBary 4152926, Florida 4155751, 32713
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Address
Life Clinical Trials
Margate 4163407, Florida 4155751, 33063
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Address
Clinical Research of West Florida, Inc.
Tampa 4174757, Florida 4155751, 33606
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Address
AdventHealth Medical Group
Tampa 4174757, Florida 4155751, 33613
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Address
Arthritis Center of North Georgia
Gainesville 4196586, Georgia 4197000, 30501
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Address
University of Massachusetts Chan Medical School
Worcester 4956184, Massachusetts 6254926, 01655
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Address
AA MRC LLC Ahmed Arif Medical Research Center
Flint 4992982, Michigan 5001836, 48504
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Address
Saint Louis Rheumatology
St Louis 4407066, Missouri 4398678, 63119
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Address
NYU Langone Brooklyn
Brooklyn 5110302, New York 5128638, 11220
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Address
DJL Clinical Research, PLLC
Charlotte 4460243, North Carolina 4482348, 28210
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Address
University of Cincinnati
Cincinnati 4508722, Ohio 5165418, 45219
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Address
Paramount Medical Research & Consulting, LLC
Middleburg Heights 5162851, Ohio 5165418, 44130
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Address
West Tennessee Research Institute
Jackson 4632595, Tennessee 4662168, 38305
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Address
Ramesh C Gupta, MD
Memphis 4641239, Tennessee 4662168, 38119
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Address
Accurate Clinical Research
Baytown 4672731, Texas 4736286, 77521
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Address
Precision Comprehensive Clinical Research Solution
Colleyville 4682478, Texas 4736286, 76034-5913
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Address
Precision Comprehensive Clinical Research Solutions
Colleyville 4682478, Texas 4736286, 76034
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Address
Accurate Clinical Research, Inc.
Humble 4699442, Texas 4736286, 77338
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Address
Sun Research Institute, LLC
San Antonio 4726206, Texas 4736286, 78215
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Advanced Rheumatology of Houston
The Woodlands 4736476, Texas 4736286, 77382
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Address
Swedish Medical Center
Seattle 5809844, Washington 5815135, 98104
International Sites
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Organizacion Medica de Investigacion (OMI)
CABA, Buenos Aires 3435907, C1015ABO
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Address
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata 3430863, Buenos Aires 3435907, 7600
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Address
Policlìnica Red Omip S.A - Ensayos Clinicos GC
Mar del Plata 3430863, Buenos Aires 3435907, B7600GNY
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Centro Dermatologico Schejtman
San Miguel 7645166, Buenos Aires 3435907, B1663
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Centro Medico Barrio Parque
Buenos Aires 3435910, Ciudad Autonoma Buenos Aires, 1425
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Instituto CAICI
Rosario 3838583, Santa Fe Province 3836276, S2000PBJ
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Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucumán 3836873, Tucumán Province 3833578, 4000
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Address
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán 3836873, Tucumán Province 3833578, T4000AXL
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Address
Investigaciones Clinicas Tucuman
San Miguel de Tucumán 3836873, Tucumán Province 3833578, T4000ICL
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Hospital Italiano de La Plata
Buenos Aires 3435910, , 17251900
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Instituto de Investigaciones Clinicas Quilmes
Buenos Aires 3435910, , 3151878
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Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, , 1425
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STAT Research S.A.
Ciudad Autonoma Buenos Aires, , C1013AAB
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Sanatorio Allende
Córdoba 3860259, , 5000
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Instituto de Reumatologia
Mendoza 3844421, , 5500
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Address
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan 3837213, , 5400
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Address
Centre Hospitalier Universitaire de Liege
Liège 2792413, , 4000
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Address
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza 3399415, Ceará 3402362, 60430-372
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Address
CEDOES - Diagnóstico e Pesquisa
Vitória 3444924, Espírito Santo 3463930, 29055-450
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Address
Clínica SER da Bahia
Salvador 3450554, Estado de Bahia 3471168, 40150-150
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Address
L2IP - Instituto de Pesquisas Clínicas Ltda.
Brasília 3469058, Federal District 3463504, 70200-730
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Address
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Santo Ângelo, Mato Grosso 3457419, 78020-500
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Address
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte 3470127, Minas Gerais 3457153, 30150-221
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Address
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora 3459505, Minas Gerais 3457153, 36010-570
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CETI - Centro de Estudos em Terapias Inovadoras Ltda.
Curitiba 3464975, Paraná 3455077, 80030-110
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LMK Serviços Médicos S/S Ltda
Porto Alegre 3452925, Rio Grande do Sul 3451133, 90480-000
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Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Sao Jose Rio Preto, São Paulo 3448433, 15090-000
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Centro Multidisciplinar de Estudos Clínicos - CEMEC
São Bernardo do Campo 3449344, São Paulo 3448433, 09715-090
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CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
São Paulo 3448439, São Paulo 3448433, 01228-200
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MC Artmed OOD
Plovdiv 728193, , 4002
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UMHAT "Pulmed" OOD
Plovdiv 728193, , 4002
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UMHAT-Plovdiv AD
Plovdiv 728193, , 4003
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DCC 1 - Ruse, EOOD
Rousse 727523, , 7002
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DCC 'Alexandrovska', EOOD
Sofia 727011, , 1431
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DCC Focus 5 - MEOH OOD
Sofia 727011, , 1463
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Address
Military Medical Academy - MHAT - Sofia
Sofia 727011, , 1606
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Centro Medico Prosalud
Santiago 3871336, , 7500000
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CTR Estudios
Santiago 3871336, , 7500571
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Enroll Spa
Santiago 3871336, , 7500587
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Address
BioMedica Research Group
Santiago 3871336, , 7500710
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Address
Xuanwu Hospital Capital Medical University
Beijing 1816670, Beijing Municipality 2038349, 100053
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Address
Dongguan People's Hospital
Dongguan 1812545, Guangdong 1809935, 523059
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Address
Guangdong Second Provincial General Hospital
Guangzhou 1809858, Guangdong 1809935, 510317
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Address
Nanfang Hospital of Southern Medical University
Guangzhou 1809858, Guangdong 1809935, 510515
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Shenzhen People's Hospital
Shenzhen 1795565, Guangdong 1809935, 518020
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Address
Hainan General Hospital
Haikou 1809078, Hainan 1809054, 570311
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Address
Xiangya Hospital, Central South University
Changsha 1815577, Hu'nan, 410008
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Address
ZhuZhou Central Hospital
Zhuzhou 1783763, Hu'nan, 412000
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Address
Jiujiang No.1 People's Hospital
Jiujiang 1805179, Jiangxi 1806222, 332000
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Address
Pingxiang People's Hospital
Pingxiang 1798654, Jiangxi 1806222, 337055
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Address
Jilin Province People's Hospital
Changchun 2038180, Jilin 2036500, 130021
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Address
Binzhou Medical University Hospital
Binzhou 1816336, Shandong 1796328, 256603
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Address
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai 1796236, Shanghai Municipality 1796231, 200001
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Address
The First Affiliated Hospital of Ningbo University
Ningbo 1799397, Zhejiang 1784764, 315010
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The First Hospital of Jilin University
Changchun 2038180, , 130021
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Address
IPS Centro Medico Julian Coronel S.A.
Cali 3687925, Valle del Cauca Department 3666313, 760001
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Address
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla 3689147, , 080020
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Address
Clínica de la Costa S.A.S
Barranquilla 3689147, , 080020
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Address
Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
Bogotá 3688689, , 110221
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Address
Servimed S.A.S.
Bucaramanga 3688465, , 680003
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Address
Preventive Care Ltda
Chía 3686675, , 250001
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Address
Healthy Medical Center
Zipaquirá 3665542, , 250252
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Address
Revmatologie s.r.o.
Brno 3078610, , 63800
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Address
Fakultni nemocnice Olomouc
Olomouc 3069011, , 77520
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Address
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand 3024635, Drôme, 63003
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Address
NNA Hospital
Athens 264371, Attica 6692632, 11521
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Address
Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
Székesfehérvár 3044774, Fejér 3053028, 8000
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Address
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest 3054643, , 1097
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Address
Bekes Varmegyei Kozponti Korhaz
Gyula 720334, , 5700
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Address
Vital Medical Center
Veszprém 3042929, , 8200
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Address
Rambam Health Care Campus
Haifa 294801, , 3109601
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Address
Meir Medical Center
Kfar Saba 294514, , 44281
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Address
Tel Aviv Sourasky Medical Center Pt
Tel Aviv 293397, , 6423906
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Address
Azienda Ospedaliera San Camillo Forlanini
Roma 8957247, , 152
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Address
JCHO Chukyo Hospital
Nagoya 1856057, Aichi-ken 1865694, 457-8510
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Address
NHO Chibahigashi National Hospital
Chiba 2113015, Chiba 2113014, 260-8712
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Address
KKR Hamanomachi Hospital
Fukuoka 1863967, Fukuoka 1863958, 810-8539
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Address
NHO Kyushu Medical Center
Fukuoka 1863967, Fukuoka 1863958, 810-8563
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Address
Hiroshima University Hospital
Hiroshima 1862415, Hiroshima 1862413, 734-8551
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Address
Tonan Hospital
Sapporo 2128295, Hokkaido 2130037, 060-0004
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Address
Japanese Red Cross Society Himeji Hospital
Himeji-shi, Hyōgo 1862047, 670-8540
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Address
Kagawa University Hospital
Kita-gun, Kagawa-ken 1860834, 761-0793
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Address
NHO Yokohama Medical Center
Yokohama 1848354, Kanagawa 1860291, 245-8575
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Address
Japanese Red Cross Kumamoto Hospital
Kumamoto 1858421, Kumamoto 1858419, 861-8520
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Address
Kindai University Hospital
Osakasayama-shi, Osaka 1853904, 589-8511
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Address
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo-To, 173-8610
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Address
Toho University Ohashi Medical Center
Meguro-ku, Tokyo-To, 153-8515
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Address
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, Tokyo-To, 162-8655
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Address
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara 4005539, Jalisco 4004156, 44650
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Address
Centro de investigacion medica y reumatologia
Guadalajara 4005539, Jalisco 4004156, 44950
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Address
Centro de Investigacion Clínica GRAMEL S.C
Mexico City 3530597, Mexico City 3527646, 03720
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Address
Clinstile, S.A. de C.V.
Mexico City 3530597, Mexico City 3527646, 06700
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Address
Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran
Mexico City 3530597, Mexico City 3527646, 14080
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Address
Consultorio Privado Dr. Miguel Cortes Hernandez
Cuernavaca 3529947, Morelos 3522961, 62448
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Address
Centro Peninsular de Investigacion Clinica, SCP
Mérida 3523349, Yucatán 3514211, 97000
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Address
Medical Care & Research SA de CV
Mérida 3523349, Yucatán 3514211, 97070
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Address
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City 4014338, , 31000
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Address
Centro de Investigacion y Atencion Integral Durango CIAID
Durango 4011743, , 34080
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Address
HMA - Hospital Maria Auxiliadora
Lima 3936456, , LIMA 29
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Address
Mary Mediatrix Medical Center
Lipa City 1706090, Batangas, 4217
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Address
Davao Doctors Hospital
Davao City 1715348, Davao Region 7521309, 8000
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Address
University of the Philippines Manila - Philippine General Hospital
Manila 1701668, National Capital Region 7521311, 1000
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Address
Far Eastern University - Dr. Nicanor Reyes Medical Foundation
Quezon City 1692192, National Capital Region 7521311, 1118
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Address
Medical Center Manila
Manila 1701668, , 1000
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Address
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok 776069, , 15-707
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Address
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz 3102014, , 87-100
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Address
Nzoz Bif-Med
Bytom 3101950, , 41-902
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Address
Pratia MCM Krakow
Krakow 3094802, , 30-510
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Address
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
Malbork 3092472, , 82-200
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Address
MICS Centrum Medyczne Warszawa
Warsaw 756135, , 00-874
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Address
Centro Reumatologico
Caguas 4563008, , 00725
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Address
S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
Brasov 683844, , 500283
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Address
S C Delta Health Care SRL
Bucharest 683506, , 14142
Status
Address
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca 681290, , 400006
Status
Address
S.C.Centrul Medical Unirea SRL
Iași 675810, , 700023
Status
Address
Institute of Rheumatology
Belgrade 792680, , 11000
Status
Address
University Clinical Center of Serbia
Belgrade 792680, , 11000
Status
Address
Clinical Center "Bezanijska Kosa "
Belgrade 792680, , 11080
Status
Address
Ajou University Hospital
Suwon 1835553, Gyeonggi-do 1841610, 16499
Status
Address
Hanyang University Seoul Hospital
Seoul 1835848, , 4763
Status
Address
Hospital Universitario Marques de Valdecilla
Santander 3109718, Castellón, 39008
Status
Address
Hospital Universitario Virgen Macarena
Seville 2510911, Sevilla, 41009
Status
Address
Hospital Universitari Vall d'Hebron
Barcelona 3128760, , 08035
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Address
Hospital Quironsalud Infanta Luisa
Seville 2510911, , 41010
Status
Address
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City 1673820, , 833401
Status
Address
Guy's Hospital
London 2643743, Greater London, SE1 9RT
Status
Address
Doncaster Royal Infirmary
Doncaster 2651123, South Yorkshire, DN2 5LT
