Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) | NCT02833350 | Trialant

Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) | NCT02833350 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

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

Zaporizhzhya, 69096, Ukraine

CI City Hospital #7

Zaporizhzhya, 69118, Ukraine

CI Zaporizhzhia Regional Clinical Hospital of ZRC

Zaporizhzhya, 69600, Ukraine