Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
A Two-Cohort Randomized Phase II, Double-Blind, Parallel Group Study in Patients With Active Rheumatoid Arthritis Evaluating the Efficacy and Safety of GDC-0853 Compared With Placebo and Adalimumab in Patients With an Inadequate Response to Previous Methotrexate Therapy (Cohort 1) and Compared With Placebo in Patients With an Inadequate Response or Intolerance to Previous TNF Therapy (Cohort 2)
2 other identifiers
interventional
578
11 countries
150
Brief Summary
This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and safety of GDC-0853 in participants with moderate to severe active RA and an inadequate response to previous methotrexate (MTX) therapy (Cohort 1) or MTX and tumor necrosis factor (TNF) therapy who may have also had exposure to no more than one non-TNF inhibitor biologic (Cohort 2).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Sep 2016
Typical duration for phase_2 rheumatoid-arthritis
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedStudy Start
First participant enrolled
September 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2018
CompletedResults Posted
Study results publicly available
September 10, 2019
CompletedJune 12, 2020
June 1, 2020
1.8 years
July 12, 2016
July 2, 2019
June 1, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1)
ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Day 84
Percentage of Participants With Adverse Events
An Adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
Day 1 up to 8 weeks after last dose (up to Week 20)
Secondary Outcomes (28)
Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1)
Day 84
Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 2)
Day 84
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Days 7, 14, 28, 56, and 84
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Days 7, 14, 28, 56, and 84
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Days 7, 14, 28, 56, and 84
- +23 more secondary outcomes
Study Arms (7)
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo
EXPERIMENTALParticipants 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.
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo
EXPERIMENTALParticipants 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.
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo
EXPERIMENTALParticipants 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.
Cohort 1: GDC-0853 Placebo + Adalimumab
ACTIVE COMPARATORParticipants 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.
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo
PLACEBO COMPARATORParticipants 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.
Cohort 2: GDC-0853 High Dose
EXPERIMENTALParticipants 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.
Cohort 2: GDC-0853 Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Participants will receive GDC-0853 at low, mid, or high doses, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Participants will receive adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks.
Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
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).
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.
Eligibility Criteria
You may qualify if:
- Have a diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for RA
- 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
You may not qualify if:
- History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (150)
Pinnacle Research Group; Llc, Central
Anniston, Alabama, 36207, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, 85306, United States
Medvin Clinical Research
Covina, California, 91723, United States
TriWest Research Associates, LLC
El Cajon, California, 92020, United States
Saint Jude Heritage Medical Grp
Fullerton, California, 92835, United States
Stanford University School of Medicine
Stanford, California, 94305-5151, United States
RASF-Clinical Research Center
Boca Raton, Florida, 33486, United States
ZASA Clinical Research
Boynton Beach, Florida, 33472, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
InVentiv Health
Miami, Florida, 33136, United States
Omega Research Consultants
Orlando, Florida, 32810, United States
McIlwain Medical Group
Tampa, Florida, 33613, United States
Institute of Arthritis Research
Idaho Falls, Idaho, 83404, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Medication Management
Greensboro, North Carolina, 27408, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Clinical Research Center of Reading
Wyomissing, Pennsylvania, 19610, United States
Metroplex Clinical Research
Dallas, Texas, 75231, United States
Baylor Research Inst.
Dallas, Texas, 75246, United States
Accurate Clinical Management - VO
Houston, Texas, 77004, United States
Accurate Clinical Research
Houston, Texas, 77089, United States
Crossroads Clinical Research, LLC
Victoria, Texas, 77901, United States
Danville Orthopedic Clinic, Inc.; Research Department
Danville, Virginia, 24541, United States
Instituto de Investigaciones Clinicas-Mar del Plata
Buenos Aires, B7600FZN, Argentina
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO, Argentina
Hospital Italiano
Buenos Aires, C1181ACH, Argentina
APRILLUS
Buenos Aires, C1194AAO, Argentina
Instituto centenario
Buenos Aires, C1204AAD, Argentina
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad Autonoma Buenos Aires, C1055AAF, Argentina
Expertia S.A- Mautalen Salud e Investigación
Ciudad Autonoma Buenos Aires, C1128AAE, Argentina
CCBR - Buenos Aires - AR; AxisMed SRL
Ciudad Autonoma Buenos Aires, C1430CKE, Argentina
ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas
Córdoba, X5000BNB, Argentina
Hospital Italiano de La Plata
La Plata, 1900, Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, B7600DHK, Argentina
Instituto de Investigaciones Clínicas Quilmes
Quilmes, 1878, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, 5400, Argentina
Centro Medico Privado de Reumatologia; Reumathology
San Miguel, T4000AXL, Argentina
CIP - Centro Internacional de Pesquisa; Pesquisa Clinica
Goiânia, Goiás, 74110-120, Brazil
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais, 36036-330, Brazil
Edumed - Educação e Saúde SA
Curitiba, Paraná, 80440-080, Brazil
Centro de Estudos em Terapias Inovadoras - CETI
Curtiba, Paraná, 80030-110, Brazil
CCBR - Synarc Centro de Pesquisa Clinica - RJ
Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-090, Brazil
LMK Serviços Médicos S/S
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
Campinas, São Paulo, 13087-567, Brazil
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, 09060-650, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
CPCLIN - Centro de Pesquisas Clínicas Ltda.; Pesquisa Clinica
São Paulo, São Paulo, 01244-030, Brazil
Instituto de Pesquisa Clínica e Medicina Avançada Ltda
São Paulo, São Paulo, 05437-010, Brazil
MHAT - Dobrich, AD
Dobrich, 9300, Bulgaria
MHAT "Eurohospital" - Plovdiv, OOD
Plovdiv, 4002, Bulgaria
MHAT Kaspela; EOOD
Plovdiv, 4002, Bulgaria
MHAT - Ruse, AD
Rousse, 7002, Bulgaria
Medizinski Zentrar-1-Sevlievo EOOD
Sevlievo, 5400, Bulgaria
MHAT "Hadzhi Dimitar", OOD
Sliven, 8800, Bulgaria
Medical Center Excelsior OOD
Sofia, 1000, Bulgaria
NMTH "Tsar Boris III"
Sofia, 1233, Bulgaria
MHAT "Lyulin", EAD
Sofia, 1336, Bulgaria
DCC "Alexandrovska", EOOD; Clinic of Neurology
Sofia, 1431, Bulgaria
UMHAT "SofiaMed", OOD
Sofia, 1750, Bulgaria
MC "Synexus - Sofia", EOOD
Sofia, 1784, Bulgaria
MHAT Dr. St. Kirkovich, AD
Stara Zagora, 6003, Bulgaria
'New Medical Center' , EOOD
Vratsa, 3000, Bulgaria
Centro de Reumatologia y Ortopedia
Barranquilla, 80020, Colombia
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
Bogotá, 110221, Colombia
Riesgo de Fractura S.A.
Bogotá, 110221, Colombia
Fundación Instituto de Reumatología Fernando Chalem
Bogotá, 111211, Colombia
Clinica de Artritis Temprana S.A.
Cali, 00000, Colombia
Hospital Pablo Tobon Uribe
Medellín, 050034, Colombia
Consultorio Medico en Fundacion el Hospitalito de morelos A.C.
Cuernavaca, Morelos, 62170, Mexico
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
Culiacán, Sinaloa, 80000, Mexico
Centro de Investigacion en Reumatologia
Mérida, Yucatán, 97070, Mexico
Consultorio Particular del Dr. Miguel Cortes Hernandez
Cuernavaca, 62290, Mexico
Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis
Mexicali, 21100, Mexico
Centro de Investigacion Clínica GRAMEL S.C
México, 03720, Mexico
Policilinica Medica de Queretaro; Rheumatology
Querétaro, 76000, Mexico
Clinical Research Institute
Tlalnepantla, 54055, Mexico
Unidad de Enfermedades Reumaticas y Cronicodegenerativas
Torreón, 27000, Mexico
NZOZ OSTEO-MEDIC S.C. Artur Racewicz, Jerzy Supronik
Bialystok, 15-351, Poland
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
Bydgoszcz, 85-168, Poland
Medica Pro Familia Spolka Akcyjna Oddzial w Katowicach
Katowice, 40-081, Poland
Centrum Medyczne Plejady
Krakow, 30-349, Poland
CCBR - Lodz - PL
Lodz, 90-368, Poland
ETYKA Osrodek Badan Kliniczynch
Olsztyn, 10-117, Poland
Ai Centrum Medyczne Sp. Z O.O Sp.K.
Poznan, 61-113, Poland
KO-MED Centra Kliniczne Staszow
Staszów, 28-200, Poland
Medycyna Kliniczna
Warsaw, 00-660, Poland
Centrum Medyczne AMED
Warsaw, 03-291, Poland
Wojewódzki Szpital Specjalistyczny we Wrocławiu
Wroclaw, 51-124, Poland
KO-MED Centra Kliniczne Zamosc
Zamość, 22400, Poland
TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich
Krasnoyarsk, Krasnoyarsk Krai, 660062, Russia
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
Moscow, Moscow Oblast, 115522, Russia
SBIH of Moscow "City Clinical Hospital # 1 n. a. N. I. Pirogov"
Moscow, Moscow Oblast, 119049, Russia
SBEI HPE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
Moscow, Moscow Oblast, 119992, Russia
Technologii zdorovia LLC
Saint Petersburg, Sankt-Peterburg, 191144, Russia
Sanavita LLC
Saint Petersburg, Sankt-Peterburg, 195257, Russia
LLC Medical Sanitary Unit
Saint Petersburg, Sankt-Peterburg, 196066, Russia
Center of Family Medicine LC
Yekaterinburg, Sankt-Peterburg, 620043, Russia
SBHI of Yaroslavl Region Clinical Hospital #3
Yaroslavl, Volgograd Oblast, 150051, Russia
SMMIH "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, Voronez, 454076, Russia
SAHI of Kem. "Regional Clinical Hospital for War Veterans"
Kemerovo, 650000, Russia
OOO Family Polyclinic
Korolev, Moscow Region, 141060, Russia
Practical Medicine
Moscow, 115404, Russia
Limited Liability Company "Centre of Medical Common Practice"
Novosibirsk, 630091, Russia
Ultramed
Omsk, 644024, Russia
City Hospital 25; Rheumatology
Saint Petersburg, 190068, Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022, Russia
SBEI HPE "Saratov State Medical University n.a. V. I. Razumovskiy" of the MoH of the RF
Saratov, 410026, Russia
SBEI HPE "Smolensk State Medical University" of the MoH of the RF
Smolensk, 214019, Russia
Siberian State Medical University
Tomsk, 634050, Russia
SHI Ulyanovsk Reg Clinical Hospital
Ulyanovsk, 432063, Russia
Territorial Clinical Hospital #2
Vladivostok, 690035, Russia
SHI Yaroslavl Regional Clinical Hospital
Yaroslavl, 150062, Russia
Institute of Rheumatology
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11040, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Institute of Treatment and Rehabilitation "Niska Banja"
Niška Banja, 18205, Serbia
Special hospital for rheumatic diseases Novi Sad
Novi Sad, 21000, Serbia
General Hospital Sabac; Department of Urology and Hemodialysis
Šabac, 15000, Serbia
Chungnam National University Hospital; Department of Internal Medicine (Rheumatology)
Daejeon, 35015, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center - Oncology
Seoul, 05505, South Korea
Ajou University Hospital
Suwon, 443-721, South Korea
CI of TRC
Ternopil, Kherson Governorate, 46002, Ukraine
Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, KIEV Governorate, 76008, Ukraine
Medical Center Medical Clinic Blagomed LLC.
Kyiv, KIEV Governorate, 01601, Ukraine
Medical Center OK!Clinic+
Kyiv, KIEV Governorate, 02091, Ukraine
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
Kyiv, KIEV Governorate, 03680, Ukraine
Clinic of Modern Rheumatology Revmotsentr LLC
Kyiv, KIEV Governorate, 04071, Ukraine
Lviv Regional Clinical Hospital Dept of Rehmuaatology D. Halytskyi Lviv NMU
Lviv, KIEV Governorate, 79010, Ukraine
CH of State Border Service of Ukraine (Military Base 2522); Dept of Therapy, D.Halytskyi Lviv NMU
Lviv, KIEV Governorate, 79014, Ukraine
A.Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, KIEV Governorate, 88018, Ukraine
Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology
Dnipro, Tavria Okruha, 49008, Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, 61039, Ukraine
Kharkiv MA of PGE of MOHU Ch of Cardiology and Functional Diagnostics
Kharkiv, 61176, Ukraine
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
Kyiv, 02232, Ukraine
MI of Helathcare Kyiv RCH P.L. Shupy NMA of PGE
Kyiv, 04107, Ukraine
Gerontology Institute of the Ukrainian AMS
Kyiv, 04114, Ukraine
Oleksandrivska Clinical Hospital
Kyiv, 1023, Ukraine
Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
Lutsk, 43024, Ukraine
City Hospital #1
Mykolaiv, 54003, Ukraine
M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA
Poltava, 36011, Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia, 21001, Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, 21018, Ukraine
City Clinical Hospital #9 Dept of Gastrosurgery SI Zaporizhzhia MA of PGE of MoHU
Zaporizhzhia, 69096, Ukraine
CI City Hospital #7
Zaporizhzhia, 69118, Ukraine
CI Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporizhzhia, 69600, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2016
First Posted
July 14, 2016
Study Start
September 9, 2016
Primary Completion
July 2, 2018
Study Completion
July 2, 2018
Last Updated
June 12, 2020
Results First Posted
September 10, 2019
Record last verified: 2020-06