A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
Study Purpose
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.
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 |
|
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 | 16 Years - 75 Years |
| Gender | All |
Inclusion Criteria:
- - Be male or female.
- - Has a documented medical history (that is, met at least 1 of the two criteria below) that participant met the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for systemic lupus erythematosus (SLE) at least 3 months prior to first dose of study agent: 1.
- - Has a positive test in the medical history and confirmed at screening for at least 1 of the following autoantibodies: antinuclear antibodies, anti-double-stranded deoxyribonucleic acid, and/or anti-Smith.
- - Has greater than or equal to (>=) 1 British Isles Lupus Assessment Group (BILAG) A and/or >= 2 BILAG B scores observed during screening.
- - Has a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score >=4 (excluding diffuse non-inflammatory alopecia) or >= 4 joints with pain and signs of inflammation at screening, Week 0, or both.
- - Has a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >=6 at screening.
- - Cannot be pregnant, nursing, intending to become pregnant, or unwilling to follow contraception or egg/sperm donation guidelines.
- - Must be receiving stable doses of >=1 protocol-permitted standard of care SLE
treatment: oral glucocorticoids, anti-malarials, immunomodulators (methotrexate,
azathioprine, 6-mercaptopurine, mycophenolate mofetil, mycophenolic acid)
Exclusion Criteria:
- Has any unstable or progressive SLE manifestation (example: central nervous system lupus, systemic vasculitis, end-stage renal disease, severe or rapidly progressive glomerulonephritis, pulmonary hemorrhage, myocarditis) that may warrant escalation in therapy beyond permitted background medications.
- - Has other co-existent inflammatory diseases (example: rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn's disease) - Has a urinary protein to creatinine ratio of greater than (>)4 gram per gram (g/g) per day.
- - Has an acute or chronic infectious illness (example: human immunodeficiency virus, hepatitis B or C virus, tuberculosis, opportunistic infections) - Has a history of cancer or lymphoproliferative disease within the last 5 years except for treated and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
- - Has any condition requiring multiple courses of systemic glucocorticoids (example: uncontrolled asthma, chronic obstructive pulmonary disease) - Has a history of major surgery within the last month.
- - Has received live virus or bacterial vaccines within 16 weeks prior to first dose of study agent or Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.
- - Has previously received ustekinumab.
- - Has received cyclophosphamide orally within 90 days or intravenously within 180 days of screening.
- - Has received a single B-cell targeted therapy (e.g. belimumab) within 3 months, >1 previous B-cell targeted therapy within 6 months, or B-cell depleting therapy (example: rituximab) within 12 months of first dose of study agent.
- - Has received protocol-prohibited oral or biologic immunomodulatory therapy in the last 3 months or less than (<)5 half-lives (whichever is longer) prior to first dose of study agent.
- - Has received adrenocorticotropic hormone (ACTH) within 1 month prior to first dose of study agent.
- - Has received epidural, intravenous, intramuscular, intraarticular, intrabursal, intralesional glucocorticoids within 6 weeks of first dose of study agent.
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. |
NCT03517722 |
|
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. |
Janssen Research & Development, LLC |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
| Principal Investigator Affiliation | Janssen Research & Development, LLC |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Argentina, Bulgaria, Canada, China, Colombia, Germany, Hungary, Japan, Korea, Republic of, Lithuania, Poland, Portugal, Russian Federation, Serbia, South Africa, Spain, Taiwan, Thailand, Ukraine, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Lupus Erythematosus, Systemic |
This study evaluates the efficacy, safety, and tolerability of ustekinumab in participants with active SLE according to Systemic Lupus International Collaborating Clinics (SLICC) criteria Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than (>=) 6, despite receiving one or more standard-of-care treatments (example, immunomodulators, antimalarial drugs, and/or glucocorticoids). The total duration of the study is up to 182 weeks, consisting of 3 study periods: a screening period (approximately 6 weeks), a double blind period (52 weeks), and an extension period (124 weeks). Other study evaluations will include pharmacokinetics, immunogenicity, biomarkers and pharmacogenomic evaluations. The safety of the participants enrolled in the study will be monitored on an ongoing basis throughout the study.
Arms
Experimental: Ustekinumab
Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160.
Experimental: Placebo
Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.
Interventions
Drug: - Placebo
Participants will receive placebo matching to ustekinumab IV or SC.
Drug: - Ustekinumab (approximately 6 mg/kg)
Participants will receive ustekinumab approximately 6 mg/kg via IV route based on body weight-range.
Drug: - Ustekinumab 90 mg
Participants will receive 90 mg ustekinumab via SC route.
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
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Status
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35294
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Address
Achieve Clinical Research, LLC
Vestavia Hills, Alabama, 35216
Status
Address
Medvin Clinical Research
Covina, California, 91722
Status
Address
Lugene Eye Institute
Glendale, California, 91204
Status
Address
C.V. Mehta, MD Medical Corp.
Hemet, California, 92543
Status
Address
University of California at San Diego
La Jolla, California, 92093
Status
Address
Advanced Medical Research - Lakewood
Lakewood, California, 90712
Status
Address
Loma Linda University
Loma Linda, California, 92350
Status
Address
Loma Linda University Health Care
Loma Linda, California, 92357
Status
Address
Valerius Medical Group & Research Center
Los Alamitos, California, 90720
Status
Address
Keck School of Medicine of USC
Los Angeles, California, 90033
Status
Address
Wallace Rheumatic Study Center
Los Angeles, California, 90048
Status
Address
East Bay Rheumatology Medical Group
San Leandro, California, 94578
Status
Address
Westlake Medical Research Clinical Trials
Thousand Oaks, California, 91360
Status
Address
University Clinical Investigators, Inc
Tustin, California, 92780
Status
Address
Inland Rheumatology Clinical Trials Inc.
Upland, California, 91786
Status
Address
University of Colorado
Aurora, Colorado, 80045
Status
Address
Denver Arthritis Clinic
Denver, Colorado, 80230
Status
Address
UPMC Lupus Center of Excellence
New Haven, Connecticut, 06520
Status
Address
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
Status
Address
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180
Status
Address
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511
Status
Address
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33309
Status
Address
University of Florida
Jacksonville, Florida, 32207
Status
Address
University of Miami Miller School of Medicine
Miami, Florida, 33136-1002
Status
Address
New Horizon Research Center
Miami, Florida, 33175
Status
Address
Rheumatology Associates of Central Florida, PA
Orlando, Florida, 32806
Status
Address
Omega Research Consultants
Orlando, Florida, 32810
Status
Address
Millennium Research
Ormond Beach, Florida, 32174
Status
Address
Integral Rheumatology & Immunology Specialists
Plantation, Florida, 33324
Status
Address
Clinical Research of West Florida
Tampa, Florida, 33603
Status
Address
Emory University
Atlanta, Georgia, 30303
Status
Address
Piedmont Healthcare - Piedmont Hospital
Atlanta, Georgia, 30309
Status
Address
DeKalb Medical Specialty Center
Decatur, Georgia, 30033
Status
Address
Rush University Medical Center
Chicago, Illinois, 60612
Status
Address
University of Chicago
Chicago, Illinois, 60637
Status
Address
Graves-Gilbert Clinic - Bowling Green
Bowling Green, Kentucky, 42101
Status
Address
Arthritis and Diabetes Clinic
Monroe, Louisiana, 71203
Status
Address
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
Status
Address
June DO, PC.
Lansing, Michigan, 48910-8595
Status
Address
St Paul Rheumatology PA
Eagan, Minnesota, 55121
Status
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Address
Oklahoma Medical Research Foundation
Las Vegas, Nevada, 89102
Status
Address
Innovative Health Research
Las Vegas, Nevada, 89128
Status
Address
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102
Status
Address
Biomedical Research Alliance Of New York
Lake Success, New York, 10075
Status
Address
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
Status
Address
NYU Center for Musculoskeletal Care
New York, New York, 10016
Status
Address
Hospital for Special Surgery
New York, New York, 10021
Status
Address
SUNY Upstate Medical University
Syracuse, New York, 13210
Status
Address
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204
Status
Address
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210
Status
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Address
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Status
Address
OK Center for Arthritis Therapy & Research, Inc.
Tulsa, Oklahoma, 74104
Status
Address
Lewis Katz School of Medicine, Temple University
Philadelphia, Pennsylvania, 19140
Status
Address
Allegheny Rheumatology/Allegheny Singer Research Institute
Wexford, Pennsylvania, 15090
Status
Address
Columbia Arthritis Center
Columbia, South Carolina, 29204
Status
Address
West Tennessee Research Institute
Jackson, Tennessee, 38305
Status
Address
Dr. Ramesh Gupta
Memphis, Tennessee, 38119
Status
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-3103
Status
Address
Amarillo Center for Clinical Research
Amarillo, Texas, 79124
Status
Address
Austin Regional Clinic
Austin, Texas, 78731
Status
Address
Arthritis Centers of Texas
Dallas, Texas, 75246
Status
Address
Sun Research Institute
San Antonio, Texas, 78215
Status
Address
UT Health Science Center at San Antonio
San Antonio, Texas, 78239
Status
Address
University of Washington
Seattle, Washington, 98195
Status
Address
Rheumatology & Pulmonary Clinic
Beckley, West Virginia, 25801
International Sites
Status
Address
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, , C1025ABI
Status
Address
Instituto Centenario
Buenos Aires, , C1204AAP
Status
Address
Centro Privado de Medicina Familiar
Buenos Aires, , C1417EYG
Status
Address
Framingham Centro Medico
Ciudad De La Plata, , B1902COS
Status
Address
Hospital Italiano de Cordoba
Cordoba, , X5004BAL
Status
Address
Hospital Escuela 'Gral. Jose F. de San Martin'
Corrientes, , 3400
Status
Address
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, , J5402DIL
Status
Address
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, , T4000AXL
Status
Address
MHAT Trimantium
Plovdiv, , 4000
Status
Address
Diagnostic-Consultative Center (DCC) Aleksandrovska
Sofia, , 1431
Status
Address
UMHAT 'St. Ivan Rilski'
Sofia, , 1612
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Address
Medical Centre Synexus
Sofia, , 1709
Status
Address
University of Calgary
Calgary, Alberta, T2N 4Z6
Status
Address
University of Manitoba
Winnipeg, Manitoba, R3A 1M4
Status
Address
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Status
Address
McMaster University
Hamilton, , L8N 3Z5
Status
Address
CHU de Québec
Quebec, , G1V-2L9
Status
Address
The First Affiliated Hospital of Baotou Medical University
Baotou, , 014010
Status
Address
Peking Union Medical College Hospital
Beijing, , 100730
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Address
West China Hospital, Sichuan University
Chengdu, , 610041
Status
Address
Guangdong Provincial People's Hospital
Guangzhou, , 510080
Status
Address
Affiliated Hospital of Inner Mongolia Med U
Hohhot, , 10000
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Address
Shanghai Ruijin Hospital
Shanghai, , 200025
Status
Address
Tianjin Medical University General Hospital
Tianjin, , 300052
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Address
Tongji Hospital of Tongji Medical College of Huangzhong Univ
Wuhan, , 430030
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Address
The 1st affiliated Hospital of Xi'an Traffic University
Xi'an, , 710061
Status
Address
Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.
Bogotá, , 110221
Status
Address
IPS Medicity SAS
Bucaramanga, ,
Status
Address
Servimed S.A.S
Bucaramanga, ,
Status
Address
Preventive Care Ltda
Chia, , 250001
Status
Address
Clinica Universitaria Bolivariana
Medellin, , 050034
Status
Address
Funcentra
Montería, , 230002
Status
Address
Charite - Universitatsmedizin Berlin (CCM)
Berlin, , 10117
Status
Address
Medizinische Hochschule Hannover
Hannover, , 30625
Status
Address
Rheumazentrum Ruhrgebiet
Herne, , 44649
Status
Address
Rheumatology Unit
Leipzig, , 04103
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Address
Universitaetsmedizin Mainz
Mainz, , 55131
Status
Address
Szt, Istvan and Szt. Laszlo
Budapest, , 1097
Status
Address
Bekes Megyei Pandy Kalman Korhaz
Gyula, , 5700
Status
Address
Leda Private Clinic
Zalaegerszeg, , H-8900
Status
Address
Chiba University Hospital
Chiba, , 260-8677
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Address
Chiba East Hospital
Chiba, , 260-8712
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Address
National Hospital Organization Kyushu Medical Center
Fukuoka, , 810-8563
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Address
Fukushima Medical University Hospital
Fukushima, , 960-1295
Status
Address
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, , 730-8619
Status
Address
Hospital of the University of Occupational and Enviromental Health
Hukuoka, , 807-8555
Status
Address
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, , 586-8521
Status
Address
Kawasaki Rheumatism and Internal Medicine Clinic
Kitakyushu, , 807-0856
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Address
Toho University Medical Center, Ohashi Hospital
Meguro-ku, , 153-8515
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Address
Nagasaki University Hospital
Nagasaki, , 852-8501
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Address
National Hospital Organization Nagoya Medical Center
Nagoya, , 460-0001
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Address
Kitasato University Hospital
Sagamihara, , 252-0375
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Address
Sapporo City General Hospital
Sapporo, , 060-8604
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Address
Hokkaido University Hospital
Sapporo, , 060-8648
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Address
Sasebo Chuo Hospital
Sasebo, , 857-1165
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Address
Tohoku University Hospital
Sendai, , 980-8574
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Address
Keio University Hospital
Shinjuku-ku, , 160-8582
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Address
National Center for Global Health and Medicine
Shinjuku-ku, , 162-8655
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Address
St. Luke's International Hospital
Tokyo, , 104-8560
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Address
Juntendo University Hospital
Tokyo, , 113-8431
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Address
Fujita Health University Hospital
Toyoake, , 470-1192
Status
Address
National Hospital Organization Yokohama Medical Center
Yokohama, , 236-0037
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Address
Daegu Catholic University Medical Center
Daegu, , 705-718
Status
Address
Chonbuk National Univ Hospital
JeonJu, , 54907
Status
Address
Seoul National University Hospital
Seoul, , 03080
Status
Address
Konkuk University Medical Center
Seoul, , 05030
Status
Address
Ajou University Hospital
Suwon, , 16499
Status
Address
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas, , LT-50161
Status
Address
Klaipeda University Hospital
Klaipeda, , LT-92288
Status
Address
Vaiku ligonine Vilniaus Universiteto ligon. Santariskiu fil
Vilnius, , 08406
Status
Address
Vilnius University Hospital Santariskiu Clinics
Vilnius, , LT-08661
Status
Address
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, , 85-168
Status
Address
Nzoz Bif-Med
Bytom, , 41-902
Status
Address
Centrum Medyczne AMED oddzial w Lodzi
Lodz, , 91-363
Status
Address
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, , 20-954
Status
Address
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, , 67-100
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Address
Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska
Sonoswiec, , 41-200
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Address
Centrum Medyczne Pratia Tychy
Tychy, , 43-100
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Address
Centrum Medyczne Pratia Warszawa
Warszawa, , 01-868
Status
Address
Reumatika-Centrum Reumatologii, NZOZ
Warszawa, , 02-691
Status
Address
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
Wroclaw, , 50-556
Status
Address
Instituto Portugues de Reumatologia
Lisboa, , 1050-034
Status
Address
Hospital Curry Cabral-Centro Hospital Lisboa Central
Lisboa, , 1069-166
Status
Address
Hospital da Luz
Lisboa, , 1500-650
Status
Address
ULSAM, EPE - Hospital Conde de Bertiandos
Ponte de Lima, , 4990-041
Status
Address
C.H. de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, , 4434-502
Status
Address
Regional Clinical Hospital for War Veterans
Kemerovo, , 650000
Status
Address
LLL Medical Center Revma-Med
Kemerovo, , 650070
Status
Address
Clinical Diagnostic Center 'Ultramed'
Omsk, , 644024
Status
Address
Leningrad region clinical hospital
Saint-Petersburg, , 194291
Status
Address
City Clinical Hospital #31
St. Petersburg, , 197110
Status
Address
Northen-Western State Medical University n.a. I.I. Mechnikov
St.-Petersburg, , 191015
Status
Address
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, , 432063
Status
Address
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, , 150003
Status
Address
Institute of Rheumatology Belgrade
Belgrade, , 11000
Status
Address
Institute of Rheumatology
Belgrade, , 11000
Status
Address
Military Medical Academy
Belgrade, , 11000
Status
Address
Clinical Hospital Center Bezanijska Kosa
Belgrade, , 11080
Status
Address
Clinical Center Kragujevac
Kragujevac, , 34000
Status
Address
Institute for Treatment and Rehabilitation Niska Banja
Niska Banja, , 18205
Status
Address
Clinical Center of Vojvodina
Vojvodina, , 21000
Status
Address
Panorama Medical Centre
Cape Town, , 7500
Status
Address
Excellentis Clinical trial Consultants
George, , 6529
Status
Address
Clinical Research Unit, University of Pretoria
Pretoria, , 0002
Status
Address
Winelands Medical Research Centre
Stellenbosch, , 7613
Status
Address
Hosp. Univ. Vall D'Hebron
Barcelona, , 8035
Status
Address
Hosp. Univ. de Basurto
Bilbao, , 48013
Status
Address
Hosp. Reina Sofia
Cordoba, , 14004
Status
Address
Hosp. Clinico San Carlos
Madrid, , 28040
Status
Address
Hosp. Univ. 12 de Octubre
Madrid, , 28041
Status
Address
Hosp. Regional Univ. de Malaga
Málaga, , 29009
Status
Address
Hosp. Univ. Infanta Sofia
San Sebastián de los Reyes, , 28702
Status
Address
Hosp. Infanta Luisa
Sevilla, , 41010
Status
Address
Hosp. Do Meixoeiro
Vigo -Pontevedra, , 36214
Status
Address
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, , 807
Status
Address
Chang Gung Memorial Hospital
Kwei-san Hsiang, , 333
Status
Address
Chung Shan Medical University Hospital
Taichung, , 402
Status
Address
China Medical University Hospital
Taichung, , 40447
Status
Address
National Taiwan University Hospital
Taipei, , 10043
Status
Address
Cathay General Hospital
Taipei, , 10601
Status
Address
Taipei Medical University
Taipei, , 11031
Status
Address
Taipei Veterans General Hospital
Taipei, , 112
Status
Address
Phramongkutklao Hospital and Medical College
Bangkok, , 10400
Status
Address
Rajavhiti Hospital
Bangkok, , 10400
Status
Address
Ramathibodi Hospital
Bangkok, , 10400
Status
Address
Siriraj Hospital
Bangkok, , 10700
Status
Address
Songklanagarind hospital
Hat Yai, , 90110
Status
Address
Chiang Mai University
Muang, , 50200
Status
Address
Mechnikov Inst, Miska bagatoprofilna likarnia #18
Kharkiv, , 61029
Status
Address
Kyiv City Clinical Hospital #3
Kyiv, , 02125
Status
Address
Kyivska oblasna klinichna likarnia
Kyiv, , 4107
Status
Address
Odeska oblasna klinichna likarnia
Odesa, , 65025
Status
Address
Multidisciplinary Medical Center of Odessa National Medical University (University Clinic №1)
Odessa, , 65026
Status
Address
Vinnytsya regional clinical hospital n.a.Pyrogov, VNMU
Vinnytsia, , 21018
Status
Address
Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
Vinnytsia, , 21029
