578
Participants
Start Date
September 9, 2016
Primary Completion Date
July 2, 2018
Study Completion Date
July 2, 2018
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.
Medical Center Excelsior OOD, Sofia
Oleksandrivska Clinical Hospital, Kyiv
"NMTH Tsar Boris III", Sofia
"MHAT Lyulin, EAD", Sofia
"DCC Alexandrovska, EOOD; Clinic of Neurology", Sofia
"UMHAT SofiaMed, OOD", Sofia
"MC Synexus - Sofia, EOOD", Sofia
Instituto de Investigaciones Clínicas Quilmes, Quilmes
Hospital Italiano de La Plata, La Plata
'New Medical Center' , EOOD, Vratsa
"MHAT Eurohospital - Plovdiv, OOD", Plovdiv
MHAT Kaspela; EOOD, Plovdiv
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica, San Juan
Medizinski Zentrar-1-Sevlievo EOOD, Sevlievo
MHAT Dr. St. Kirkovich, AD, Stara Zagora
MHAT - Ruse, AD, Rousse
"MHAT Hadzhi Dimitar, OOD", Sliven
MHAT - Dobrich, AD, Dobrich
Institute of Rheumatology, Belgrade
Military Medical Academy, Belgrade
Seoul National University Bundang Hospital, Gyeonggi-do
General Hospital Sabac; Department of Urology and Hemodialysis, Šabac
"Institute of Treatment and Rehabilitation Niska Banja", Niška Banja
Clinical Research Center of Reading, Wyomissing
Special hospital for rheumatic diseases Novi Sad, Novi Sad
Private Small Enterprise Medical Center Pulse, Vinnytsia
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU, Vinnytsia
Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis, Mexicali
KO-MED Centra Kliniczne Zamosc, Zamość
Danville Orthopedic Clinic, Inc.; Research Department, Danville
Unidad de Enfermedades Reumaticas y Cronicodegenerativas, Torreón
Medication Management, Greensboro
Omega Research Consultants, Orlando
InVentiv Health, Miami
ZASA Clinical Research, Boynton Beach
RASF-Clinical Research Center, Boca Raton
McIlwain Medical Group, Tampa
Clinical Research of West Florida, Clearwater
Clinical Center Kragujevac, Kragujevac
Chungnam National University Hospital; Department of Internal Medicine (Rheumatology), Daejeon
M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA, Poltava
Pinnacle Research Group; Llc, Central, Anniston
Volyn Regional Center of Cardiovascular Pathology and Thrombolysis, Lutsk
CI of TRC, Ternopil
Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology, Dnipro
City Hospital #1, Mykolaiv
Clinical Research Institute, Tlalnepantla
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine, Kharkiv
Kharkiv MA of PGE of MOHU Ch of Cardiology and Functional Diagnostics, Kharkiv
Chonnam National University Hospital, Gwangju
Consultorio Medico en Fundacion el Hospitalito de morelos A.C., Cuernavaca
Consultorio Particular del Dr. Miguel Cortes Hernandez, Cuernavaca
City Clinical Hospital #9 Dept of Gastrosurgery SI Zaporizhzhia MA of PGE of MoHU, Zaporizhzhia
CI City Hospital #7, Zaporizhzhia
CI Zaporizhzhia Regional Clinical Hospital of ZRC, Zaporizhzhia
Metroplex Clinical Research, Dallas
Baylor Research Inst., Dallas
Policilinica Medica de Queretaro; Rheumatology, Querétaro
Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU, Ivano-Frankivsk
Accurate Clinical Management - VO, Houston
Accurate Clinical Research, Houston
Crossroads Clinical Research, LLC, Victoria
Lviv Regional Clinical Hospital Dept of Rehmuaatology D. Halytskyi Lviv NMU, Lviv
CH of State Border Service of Ukraine (Military Base 2522); Dept of Therapy, D.Halytskyi Lviv NMU, Lviv
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI), Culiacán
Centro de Reumatologia y Ortopedia, Barranquilla
Institute of Arthritis Research, Idaho Falls
Advanced Clinical Research, Meridian
Arizona Arthritis & Rheumatology Associates, P.C., Glendale
A.Novak Transcarpathian Regional Clinical Hospital, Uzhhorod
Medvin Clinical Research, Covina
TriWest Research Associates, LLC, El Cajon
Saint Jude Heritage Medical Grp, Fullerton
Centro de Investigacion en Reumatologia, Mérida
Oregon Health and Science University, Portland
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM, Bogotá
Riesgo de Fractura S.A., Bogotá
Fundación Instituto de Reumatología Fernando Chalem, Bogotá
Practical Medicine, Moscow
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova, Moscow
"SBIH of Moscow City Clinical Hospital # 1 n. a. N. I. Pirogov", Moscow
"SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov of the MoH of the RF", Moscow
OOO Family Polyclinic, Korolev, Moscow Region
SBHI of Yaroslavl Region Clinical Hospital #3, Yaroslavl
SHI Yaroslavl Regional Clinical Hospital, Yaroslavl
City Hospital 25; Rheumatology, Saint Petersburg
Technologii zdorovia LLC, Saint Petersburg
Sanavita LLC, Saint Petersburg
LLC Medical Sanitary Unit, Saint Petersburg
Pavlov First Saint Petersburg State Medical University, Saint Petersburg
"SBEI HPE Smolensk State Medical University of the MoH of the RF", Smolensk
"SBEI HPE Saratov State Medical University n.a. V. I. Razumovskiy of the MoH of the RF", Saratov
SHI Ulyanovsk Reg Clinical Hospital, Ulyanovsk
"SMMIH Chelyabinsk Regional Clinical Hospital", Chelyabinsk
Center of Family Medicine LC, Yekaterinburg
"Limited Liability Company Centre of Medical Common Practice", Novosibirsk
Siberian State Medical University, Tomsk
Ultramed, Omsk
"SAHI of Kem. Regional Clinical Hospital for War Veterans", Kemerovo
"TSBIH Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich", Krasnoyarsk
Territorial Clinical Hospital #2, Vladivostok
Stanford University School of Medicine, Stanford
Instituto de Investigaciones Clinicas-Mar del Plata, Buenos Aires
Organizacion Medica de Investigacion, Buenos Aires
Hospital Italiano, Buenos Aires
APRILLUS, Buenos Aires
Instituto centenario, Buenos Aires
Centro de Investigacion en Enfermedades Reumaticas CIER, Ciudad Autonoma Buenos Aires
Expertia S.A- Mautalen Salud e Investigación, Ciudad Autonoma Buenos Aires
CCBR - Buenos Aires - AR; AxisMed SRL, Ciudad Autonoma Buenos Aires
ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas, Córdoba
Centro de Investigaciones Medicas Mar Del Plata, Mar del Plata
Centro Medico Privado de Reumatologia; Reumathology, San Miguel
CIP - Centro Internacional de Pesquisa; Pesquisa Clinica, Goiânia
Centro Mineiro de Pesquisa - CMIP, Juiz de Fora
Edumed - Educação e Saúde SA, Curitiba
Centro de Estudos em Terapias Inovadoras - CETI, Curtiba
CCBR - Synarc Centro de Pesquisa Clinica - RJ, Rio de Janeiro
Hospital Sao Vicente de Paulo, Passo Fundo
LMK Serviços Médicos S/S, Porto Alegre
CAEP - Centro Avancado de Estudos e Pesquisas Ltda., Campinas
Faculdade de Medicina do ABC - FMABC, Santo André
Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto
CPCLIN - Centro de Pesquisas Clínicas Ltda.; Pesquisa Clinica, São Paulo
Instituto de Pesquisa Clínica e Medicina Avançada Ltda, São Paulo
Hospital Pablo Tobon Uribe, Medellín
Clinica de Artritis Temprana S.A., Santiago de Cali
Centro de Investigacion Clínica GRAMEL S.C, México
NZOZ OSTEO-MEDIC S.C. Artur Racewicz, Jerzy Supronik, Bialystok
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela, Bydgoszcz
Medica Pro Familia Spolka Akcyjna Oddzial w Katowicach, Katowice
Centrum Medyczne Plejady, Krakow
CCBR - Lodz - PL, Lodz
ETYKA Osrodek Badan Kliniczynch, Olsztyn
Ai Centrum Medyczne Sp. Z O.O Sp.K., Poznan
KO-MED Centra Kliniczne Staszow, Staszów
Medycyna Kliniczna, Warsaw
Centrum Medyczne AMED, Warsaw
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Wroclaw
Seoul National University Hospital, Seoul
Konkuk University Medical Center, Seoul
Asan Medical Center - Oncology, Seoul
Ajou University Hospital, Suwon
Medical Center Medical Clinic Blagomed LLC., Kyiv
Medical Center OK!Clinic+, Kyiv
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Kyiv
Clinic of Modern Rheumatology Revmotsentr LLC, Kyiv
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv, Kyiv
MI of Helathcare Kyiv RCH P.L. Shupy NMA of PGE, Kyiv
Gerontology Institute of the Ukrainian AMS, Kyiv
Lead Sponsor
Genentech, Inc.
INDUSTRY