Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
NCT ID: NCT02833350
Last Updated: 2020-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
578 participants
INTERVENTIONAL
2016-09-09
2018-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1: GDC-0853 High Dose + Adalimumab Placebo
Participants of Cohort 1 will receive GDC-0853 high dose, orally once daily along with placebo matched to adalimumab, subcutaneously every 2 weeks (Q2W) starting on Day 1 for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 milligrams per week (mg/week) (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
GDC-0853
Participants will receive GDC-0853 at low, mid, or high doses, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Folic Acid
Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
MTX
Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).
Placebo
Participants will receive placebo matched to adalimumab, subcutaneously Q2W and/or placebo matched to GDC-0853, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo
Participants of Cohort 1 will receive GDC-0853 low dose, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
GDC-0853
Participants will receive GDC-0853 at low, mid, or high doses, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Folic Acid
Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
MTX
Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).
Placebo
Participants will receive placebo matched to adalimumab, subcutaneously Q2W and/or placebo matched to GDC-0853, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo
Participants of Cohort 1 will receive GDC-0853 mid dose, orally twice daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
GDC-0853
Participants will receive GDC-0853 at low, mid, or high doses, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Folic Acid
Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
MTX
Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).
Placebo
Participants will receive placebo matched to adalimumab, subcutaneously Q2W and/or placebo matched to GDC-0853, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Cohort 1: GDC-0853 Placebo + Adalimumab
Participants of Cohort 1 will receive placebo matched to GDC-0853, orally once daily along with adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
Adalimumab
Participants will receive adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks.
Folic Acid
Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
MTX
Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).
Placebo
Participants will receive placebo matched to adalimumab, subcutaneously Q2W and/or placebo matched to GDC-0853, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo
Participants of Cohort 1 will receive placebo matched to GDC-0853, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
Folic Acid
Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
MTX
Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).
Placebo
Participants will receive placebo matched to adalimumab, subcutaneously Q2W and/or placebo matched to GDC-0853, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Cohort 2: GDC-0853 High Dose
Participants of Cohort 2 will receive GDC-0853 high dose, orally twice daily for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
GDC-0853
Participants will receive GDC-0853 at low, mid, or high doses, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Folic Acid
Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
MTX
Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).
Cohort 2: GDC-0853 Placebo
Participants of Cohort 2 will receive placebo matched to GDC-0853, orally twice daily for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
Folic Acid
Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
MTX
Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).
Placebo
Participants will receive placebo matched to adalimumab, subcutaneously Q2W and/or placebo matched to GDC-0853, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Interventions
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GDC-0853
Participants will receive GDC-0853 at low, mid, or high doses, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Adalimumab
Participants will receive adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks.
Folic Acid
Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
MTX
Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).
Placebo
Participants will receive placebo matched to adalimumab, subcutaneously Q2W and/or placebo matched to GDC-0853, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* RA disease activity by joint counts and laboratory markers of inflammation: greater than or equal to (\>=) 6 tender/painful joints on motion (68 joint count) and \>= 6 swollen joints (66 joint count) at both screening and Day 1 (randomization)
* For MTX-inadequate response (IR) participants: must have had an inadequate response to MTX
* For TNF-IR participants: must have had an inadequate response or intolerance to previous treatment with at least 1 and no more than 2 biologic TNF-alpha inhibitors and may have also been exposed to no more than one biologic non-TNF-alpha inhibitor
* High sensitivity C-reactive protein of \>= 0.400 milligrams per deciliter (mg/dL) for Cohort 1 and \>= 0.650 mg/dL for Cohort 2 at screening
Exclusion Criteria
* For MTX-IR participants: History of treatment with any TNF inhibitor, including biosimilar equivalents and history of treatment with biologic non-TNF-alpha inhibitor for RA
* For all participants: Previous treatment with cell-depleting therapy including B cell-depleting therapy (e.g., anti-cluster of differentiation 20-directed therapy such as rituximab), tofacitinib, or other Janus kinase inhibitor(s), or alkylating agents
* Current treatment with medications that are well known to prolong the QT interval at doses that have a clinically meaningful effect on QT
* History of non-gallstone-related pancreatitis or chronic pancreatitis
* Evidence of serious uncontrolled concomitant cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease
* Evidence of chronic and/or active hepatitis B or C
* Women who are pregnant, nursing (breast feeding), or intending to become pregnant during the study or within 60 days after completion of the study
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Pinnacle Research Group; Llc, Central
Anniston, Alabama, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, United States
Medvin Clinical Research
Covina, California, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Saint Jude Heritage Medical Grp
Fullerton, California, United States
Stanford University School of Medicine
Stanford, California, United States
RASF-Clinical Research Center
Boca Raton, Florida, United States
ZASA Clinical Research
Boynton Beach, Florida, United States
Clinical Research of West Florida
Clearwater, Florida, United States
InVentiv Health
Miami, Florida, United States
Omega Research Consultants
Orlando, Florida, United States
McIlwain Medical Group
Tampa, Florida, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Advanced Clinical Research
Meridian, Idaho, United States
Medication Management
Greensboro, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Clinical Research Center of Reading
Wyomissing, Pennsylvania, United States
Metroplex Clinical Research
Dallas, Texas, United States
Baylor Research Inst.
Dallas, Texas, United States
Accurate Clinical Management - VO
Houston, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Crossroads Clinical Research, LLC
Victoria, Texas, United States
Danville Orthopedic Clinic, Inc.; Research Department
Danville, Virginia, United States
Instituto de Investigaciones Clinicas-Mar del Plata
Buenos Aires, , Argentina
Organizacion Medica de Investigacion
Buenos Aires, , Argentina
Hospital Italiano
Buenos Aires, , Argentina
APRILLUS
Buenos Aires, , Argentina
Instituto centenario
Buenos Aires, , Argentina
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad Autonoma Buenos Aires, , Argentina
Expertia S.A- Mautalen Salud e Investigación
Ciudad Autonoma Buenos Aires, , Argentina
CCBR - Buenos Aires - AR; AxisMed SRL
Ciudad Autonoma Buenos Aires, , Argentina
ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas
Córdoba, , Argentina
Hospital Italiano de La Plata
La Plata, , Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, , Argentina
Instituto de Investigaciones Clínicas Quilmes
Quilmes, , Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, , Argentina
Centro Medico Privado de Reumatologia; Reumathology
San Miguel, , Argentina
CIP - Centro Internacional de Pesquisa; Pesquisa Clinica
Goiânia, Goiás, Brazil
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais, Brazil
Edumed - Educação e Saúde SA
Curitiba, Paraná, Brazil
Centro de Estudos em Terapias Inovadoras - CETI
Curtiba, Paraná, Brazil
CCBR - Synarc Centro de Pesquisa Clinica - RJ
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
LMK Serviços Médicos S/S
Porto Alegre, Rio Grande do Sul, Brazil
CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
Campinas, São Paulo, Brazil
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
CPCLIN - Centro de Pesquisas Clínicas Ltda.; Pesquisa Clinica
São Paulo, São Paulo, Brazil
Instituto de Pesquisa Clínica e Medicina Avançada Ltda
São Paulo, São Paulo, Brazil
MHAT - Dobrich, AD
Dobrich, , Bulgaria
MHAT "Eurohospital" - Plovdiv, OOD
Plovdiv, , Bulgaria
MHAT Kaspela; EOOD
Plovdiv, , Bulgaria
MHAT - Ruse, AD
Rousse, , Bulgaria
Medizinski Zentrar-1-Sevlievo EOOD
Sevlievo, , Bulgaria
MHAT "Hadzhi Dimitar", OOD
Sliven, , Bulgaria
Medical Center Excelsior OOD
Sofia, , Bulgaria
NMTH "Tsar Boris III"
Sofia, , Bulgaria
MHAT "Lyulin", EAD
Sofia, , Bulgaria
DCC "Alexandrovska", EOOD; Clinic of Neurology
Sofia, , Bulgaria
UMHAT "SofiaMed", OOD
Sofia, , Bulgaria
MC "Synexus - Sofia", EOOD
Sofia, , Bulgaria
MHAT Dr. St. Kirkovich, AD
Stara Zagora, , Bulgaria
'New Medical Center' , EOOD
Vratsa, , Bulgaria
Centro de Reumatologia y Ortopedia
Barranquilla, , Colombia
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
Bogotá, , Colombia
Riesgo de Fractura S.A.
Bogotá, , Colombia
Fundación Instituto de Reumatología Fernando Chalem
Bogotá, , Colombia
Clinica de Artritis Temprana S.A.
Cali, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Consultorio Medico en Fundacion el Hospitalito de morelos A.C.
Cuernavaca, Morelos, Mexico
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
Culiacán, Sinaloa, Mexico
Centro de Investigacion en Reumatologia
Mérida, Yucatán, Mexico
Consultorio Particular del Dr. Miguel Cortes Hernandez
Cuernavaca, , Mexico
Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis
Mexicali, , Mexico
Centro de Investigacion Clínica GRAMEL S.C
México, , Mexico
Policilinica Medica de Queretaro; Rheumatology
Querétaro, , Mexico
Clinical Research Institute
Tlalnepantla, , Mexico
Unidad de Enfermedades Reumaticas y Cronicodegenerativas
Torreón, , Mexico
NZOZ OSTEO-MEDIC S.C. Artur Racewicz, Jerzy Supronik
Bialystok, , Poland
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
Bydgoszcz, , Poland
Medica Pro Familia Spolka Akcyjna Oddzial w Katowicach
Katowice, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
CCBR - Lodz - PL
Lodz, , Poland
ETYKA Osrodek Badan Kliniczynch
Olsztyn, , Poland
Ai Centrum Medyczne Sp. Z O.O Sp.K.
Poznan, , Poland
KO-MED Centra Kliniczne Staszow
Staszów, , Poland
Medycyna Kliniczna
Warsaw, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
Wojewódzki Szpital Specjalistyczny we Wrocławiu
Wroclaw, , Poland
KO-MED Centra Kliniczne Zamosc
Zamość, , Poland
TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich
Krasnoyarsk, Krasnoyarsk Krai, Russia
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
Moscow, Moscow Oblast, Russia
SBIH of Moscow "City Clinical Hospital # 1 n. a. N. I. Pirogov"
Moscow, Moscow Oblast, Russia
SBEI HPE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
Moscow, Moscow Oblast, Russia
Technologii zdorovia LLC
Saint Petersburg, Sankt-Peterburg, Russia
Sanavita LLC
Saint Petersburg, Sankt-Peterburg, Russia
LLC Medical Sanitary Unit
Saint Petersburg, Sankt-Peterburg, Russia
Center of Family Medicine LC
Yekaterinburg, Sankt-Peterburg, Russia
SBHI of Yaroslavl Region Clinical Hospital #3
Yaroslavl, Volgograd Oblast, Russia
SMMIH "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, Voronez, Russia
SAHI of Kem. "Regional Clinical Hospital for War Veterans"
Kemerovo, , Russia
OOO Family Polyclinic
Korolev, Moscow Region, , Russia
Practical Medicine
Moscow, , Russia
Limited Liability Company "Centre of Medical Common Practice"
Novosibirsk, , Russia
Ultramed
Omsk, , Russia
City Hospital 25; Rheumatology
Saint Petersburg, , Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, , Russia
SBEI HPE "Saratov State Medical University n.a. V. I. Razumovskiy" of the MoH of the RF
Saratov, , Russia
SBEI HPE "Smolensk State Medical University" of the MoH of the RF
Smolensk, , Russia
Siberian State Medical University
Tomsk, , Russia
SHI Ulyanovsk Reg Clinical Hospital
Ulyanovsk, , Russia
Territorial Clinical Hospital #2
Vladivostok, , Russia
SHI Yaroslavl Regional Clinical Hospital
Yaroslavl, , Russia
Institute of Rheumatology
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Institute of Treatment and Rehabilitation "Niska Banja"
Niška Banja, , Serbia
Special hospital for rheumatic diseases Novi Sad
Novi Sad, , Serbia
General Hospital Sabac; Department of Urology and Hemodialysis
Šabac, , Serbia
Chungnam National University Hospital; Department of Internal Medicine (Rheumatology)
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Asan Medical Center - Oncology
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
CI of TRC
Ternopil, Kherson Governorate, Ukraine
Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, KIEV Governorate, Ukraine
Medical Center Medical Clinic Blagomed LLC.
Kyiv, KIEV Governorate, Ukraine
Medical Center OK!Clinic+
Kyiv, KIEV Governorate, Ukraine
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
Kyiv, KIEV Governorate, Ukraine
Clinic of Modern Rheumatology Revmotsentr LLC
Kyiv, KIEV Governorate, Ukraine
Lviv Regional Clinical Hospital Dept of Rehmuaatology D. Halytskyi Lviv NMU
Lviv, KIEV Governorate, Ukraine
CH of State Border Service of Ukraine (Military Base 2522); Dept of Therapy, D.Halytskyi Lviv NMU
Lviv, KIEV Governorate, Ukraine
A.Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, KIEV Governorate, Ukraine
Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology
Dnipro, Tavria Okruha, Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, , Ukraine
Kharkiv MA of PGE of MOHU Ch of Cardiology and Functional Diagnostics
Kharkiv, , Ukraine
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
Kyiv, , Ukraine
MI of Helathcare Kyiv RCH P.L. Shupy NMA of PGE
Kyiv, , Ukraine
Gerontology Institute of the Ukrainian AMS
Kyiv, , Ukraine
Oleksandrivska Clinical Hospital
Kyiv, , Ukraine
Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
Lutsk, , Ukraine
City Hospital #1
Mykolaiv, , Ukraine
M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA
Poltava, , Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia, , Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, , Ukraine
City Clinical Hospital #9 Dept of Gastrosurgery SI Zaporizhzhia MA of PGE of MoHU
Zaporizhzhia, , Ukraine
CI City Hospital #7
Zaporizhzhia, , Ukraine
CI Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporizhzhia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-000335-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA29350
Identifier Type: -
Identifier Source: org_study_id
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