A study of long-term effects of fenebrutinib treatment in patients with rheumatoid arthritis

A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350 (NCT02833350)

  • Autoimmune Disorder
  • Rheumatoid Arthritis
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • Argentina
  • Brazil
  • Bulgaria
  • Colombia
  • Mexico
  • Poland
  • Russia
  • Serbia
  • Ukraine
  • United States
Trial Identifier:

NCT02983227 2016-000498-19 GA30067

  • A.Novak Transcarpathian Regional Clinical Hospital

    22 Kapushanska St88000UzhhorodUkraine
  • Accurate Clinical Research

    11003 Resource Pkwy77089HoustonUnited States
  • Ai Centrum Medyczne Sp. Z O.O Sp.K.

    1 Świętojańska61-113PoznańPoland
  • APRILLUS

    2554 Av. CorrientesC1046Buenos AiresArgentina
  • Arizona Arthritis & Rheumatology Associates, P.C.

    5681 W Beverly Ln85306GlendaleUnited States
  • Baylor Research Inst.

    3434 Live Oak St75204DallasUnited States
  • CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

    245 R. José Geraldo Cerebino Christófaro13087-567São PauloBrazil
  • CCBR - Buenos Aires - AR; AxisMed SRL

    4693 Ruiz HuidobroC1430ckeArgentina
  • CCBR - Lodz - PL

    1/3 Targowa90-022ŁódźPoland
  • CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

    Rio de JaneiroBrazil
  • Center of Family Medicine LC

    6450 38th Ave N33710St. PetersburgUnited States
  • Centro de Estudos em Terapias Inovadoras - CETI

    306 Av. Agostinho Leão Junior80030-110ParanáBrazil
  • Centro de Investigacion Clínica GRAMEL S.C

    217 Holbein03720Ciudad de MéxicoMexico
  • Centro de Investigacion de Tratam Innovadores de Sin SC

    80318South CarolinaMexico
  • Centro de Investigacion en Enfermedades Reumaticas CIER

    1525 Av. CórdobaC1055Buenos AiresArgentina
  • Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis

    430 Calz de las Americas21200MexicaliMexico
  • Centro de Investigacion en Reumatologia

    97070MéridaMexico
  • Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM

    110221BogotáColombia
  • Centro de Investigacion Medico Asistencial S.A.S

    ## 82 – 120 Cra. 49c080020BarranquillaColombia
  • Centro de Investigaciones Medicas Mar Del Plata

    3083 Av. ColónB7600Mar del PlataArgentina
  • Centro Medico Privado de Reumatologia; Reumathology

    506 LavalleT4000San Miguel de TucumánArgentina
  • Centrum Medyczne AMED

    93 św. Wincentego03-291WarszawaPoland
  • Centrum Medyczne Pratia Katowice I

    13 Dąbrówki40-081KatowicePoland
  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

    532 Francisco N. Laprida EsteJ5402dilArgentina
  • CH of State Border Service of Ukraine (Military Base 2522); Dept of Therapy, D.Halytskyi Lviv NMU

    02000KyivUkraine
  • CI City Hospital #1

    80 Peremohy St69005ZaporizhzhiaUkraine
  • CI City Hospital #7

    69061ZaporizhzhiaUkraine
  • CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis

    LutskUkraine
  • CI of Healthcare Kharkiv CCH #8 Dept of Therapy Kharkiv MA of PGE of MOHU

    KharkivUkraine
  • CI of TRC

    46000TernopilUkraine
  • CI Zaporizhzhia Regional Clinical Hospital of ZRC

    69061ZaporizhzhiaUkraine
  • CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica

    129-219 R. 9-B74110-120GoiásBrazil
  • City Clinical Hospital #9 Dept of Therapy SI Zaporizhzhia MA of PGE of MoHU

    1 Shchaslyva St69000ZaporizhzhiaUkraine
  • Clinical Center Kragujevac

    30 Zmaj JovinaKragujevacSerbia
  • Clinical Research Institute

    54055Ciudad de MéxicoMexico
  • Clinical Research of West Florida

    2147 NE Coachman Rd33765ClearwaterUnited States
  • CMiP - Centro Mineiro de Pesquisa*X*

    186 R. Delfim Moreira36010-570Minas GeraisBrazil
  • CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

    13 Profesora Pidvysots'koho St01103KyivUkraine
  • Consultorio Medico en Fundacion el Hospitalito de morelos A.C.

    220 Av. Emiliano Zapata62170CuernavacaMexico
  • Consultorio Particular del Dr. Miguel Cortes Hernandez

    203 Av. Cuauhtémoc62270CuernavacaMexico
  • DCC "Alexandrovska", EOOD; Clinic of Neurology

    1 ul. "Sveti Georgi Sofiyski"1431SofiaBulgaria
  • ETYKA Osrodek Badan Kliniczynch

    13 1 Maja11-041OlsztynPoland
  • Expertia S.A- Mautalen Salud e Investigación

    1860 AzcuénagaC1128AAFArgentina
  • Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova

    115522MoscowRussia
  • General Hospital "Dr Laza K. Lazarevic" Sabac

    31 Popa Karana15000ŠabacSerbia
  • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

    KharkivUkraine
  • ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas

    CórdobaArgentina
  • IMA Brasil - Instituto de Medicina Avancada

    55 Praça Américo Jacomino05437-010São PauloBrazil
  • Institute of Rheumatology

    BeogradSerbia
  • Institute of Treatment and Rehabilitation "Niska Banja"

    Niška BanjaSerbia
  • Instituto centenario

    3855 Av. RivadaviaC1204Buenos AiresArgentina
  • Instituto de Investigaciones Clinicas

    160 ParaguayS2000RosarioArgentina
  • Instituto de Investigaciones Clinicas-Mar del Plata

    3456 Av. ColónB7600Mar del PlataArgentina
  • KO-MED Centra Kliniczne Zamosc

    1 Peowiaków22-400zamo_Poland
  • Limited Liability Company "Centre of Medical Common Practice"

    630091NovosibirskRussia
  • LLC Medical Sanitary Unit

    78 embankment Riv Moyka190000Sankt-PeterburgRussia
  • LMK Serviços Médicos S/S

    46 R. Doná Regina91110-020Rio Grande do SulBrazil
  • Lviv Regional Clinical Hospital Dept of Rehmuaatology D. Halytskyi Lviv NMU

    7 Chernihivska St79000L'vivUkraine
  • M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA

    36000PoltavaUkraine
  • MC "Synexus - Sofia", EOOD

    SofiaBulgaria
  • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

    02000KyivUkraine
  • Medical Center Excelsior OOD

    4 ul. "Golo Bardo"1407SofiaBulgaria
  • Medical Center of Limited Liability Company Medical Clinic Blagomed

    20 Esplanadna St02000KyivUkraine
  • Medical Center of Revmotsentr LLC

    4 Volodymyra Vynnychenka St04053KyivUkraine
  • Medication Management

    802 Green Valley Rd27408GreensboroUnited States
  • Medizinski Zentrar-1-Sevlievo EOOD

    147 ul. "Stefan Peshev"5400SevlievoBulgaria
  • Medvin Clinical Research

    12456 Washington Blvd90602WhittierUnited States
  • Medycyna Kliniczna

    53 Wronia00-874WarszawaPoland
  • Metroplex Clinical Research Centre

    8144 Walnut Hl Ln75231DallasUnited States
  • MHAT "Eurohospital" - Plovdiv, OOD; Internal Department

    79 ul. "Komatevsko Shose"4004PlovdivBulgaria
  • MHAT "Hadzhi Dimitar", OOD

    2 ul. "Asenova"8800SlivenBulgaria
  • MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE

    04112KyivUkraine
  • National Pirogov Memorial Medical University

    56 Pyrohova St21018VinnytsiaUkraine
  • NIH "Departmental Hospital on Station Smolensk of OJSC "Russian Railways"

    214025SmolenskRussia
  • NMTH "Tsar Boris III"

    1233 bul. "Tsar Boris III"1619SofiaBulgaria
  • NZOZ ZDROWIE Osteo-Medic

    81 Wiejska15-351BiałystokPoland
  • OOO Family Polyclinic

    141060KorolyovRussia
  • Oregon Health & Science Uni

    3181 SW Sam Jackson Park Rd97239PortlandUnited States
  • Policlinica Medica de Queretaro S.C.

    4 Calle José María Pino Suárez76000Santiago de QuerétaroMexico
  • Practical Medicine

    3 1-й Котляковский пер.115478MoskvaRussia
  • Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology

    49000DniproUkraine
  • RASF-Clinical Research Center

    33486Boca RatonUnited States
  • Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU

    76000Ivano-Frankivs'kUkraine
  • Riesgo de Fractura S.A.

    98-16 Cra. 12110221BogotáColombia
  • SAHI of Kem. "Regional Clinical Hospital for War Veterans"

    18 Ulitsa 50 Let Oktyabrya650000KemerovoRussia
  • Saint Jude Heritage Medical Grp

    433 W Bastanchury Rd92835FullertonUnited States
  • Sanavita LLC

    8, к.2 Prospekt Nauki195257Sankt-PeterburgRussia
  • SBHI of Yaroslavl Region Clinical Hospital #3

    150051YaroslavlRussia
  • SBIH of Moscow "City Clinical Hospital # 1 n. a. N. I. Pirogov"

    119049MoscowRussia
  • SBIH of Yaroslavl region " Regional Clinical Hospital "; Therapy

    150062Yaroslavl OblastRussia
  • SEIHPE Saratov State Medical University n.a. V.I. Razumovskiy

    137 Bol'shaya Sadovaya Ulitsa410000SaratovRussia
  • SHI Ulyanovsk Reg Clinical Hospital

    26 Ulitsa Kuznetsova432000ulyanovskRussia
  • SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU

    5 Narodnoho Opolchennya St03680KyivUkraine
  • Siberian State Medical University

    2 Moskovskiy Trakt634050TomskRussia
  • SMMIH "Chelyabinsk Regional Clinical Hospital"

    42 Ulitsa Blyukhera454087ChelyabinskRussia
  • SPb SBIH "Clinical Rheumatological Hospital # 25"

    190068Saint PetersburgRussia
  • Special hospital for rheumatic diseases Novi Sad

    68 FutoškaNovi SadSerbia
  • Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

    75 Kornela Ujejskiego85-168BydgoszczPoland
  • Territorial Clinical Hospital #2

    6 Primorskaya Ulitsa690063VladivostokRussia
  • TriWest Research Associates, LLC

    300 S Pierce St92020El CajonUnited States
  • Ultramed

    12 Ulitsa Chkalova644024OmskRussia
  • UMHAT "Kaspela", EOOD

    64 ul. "Sofia"4001PlovdivBulgaria
  • UMHAT "SofiaMed", OOD; Department of Neurology

    SofiaBulgaria
  • Unidad de Enfermedades Reumaticas y Cronicodegenerativas

    #798 Oriente27000TorreónMexico
    Show trial locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Trial Summary

    A study to evaluate the long-term safety and efficacy of GDC-0853 in participants with moderate to severe active Rheumatoid Arthritis (RA) who have completed 12 weeks of study treatment in Study GA29350. Eligible participants from Study GA29350 who elect to participate will receive treatment with GDC-0853 twice daily (BID) in an open-label fashion for 52 weeks, followed by a safety follow-up period of 8 weeks.

    Genentech, Inc. Sponsor
    Phase 2 Phase
    NCT02983227, GA30067, 2016-000498-19 Trial Identifier
    All Gender
    ≥ 18 Years & ≤ 76 Years Age
    No Healthy Volunteers

    Researchers wanted to find out what effect, good or bad, fenebrutinib caused in patients with rheumatoid arthritis (RA) who received long-term treatment. This was an “open-label extension” study. Open-label meant that patients and researchers knew what treatment the patients were getting. It was an “extension study” because RA patients were required to have previously participated in another study that investigated fenebrutinib (and placebo) for RA disease.

    Trial Summary

    A study to evaluate the long-term safety and efficacy of GDC-0853 in participants with moderate to severe active Rheumatoid Arthritis (RA) who have completed 12 weeks of study treatment in Study GA29350. Eligible participants from Study GA29350 who elect to participate will receive treatment with GDC-0853 twice daily (BID) in an open-label fashion for 52 weeks, followed by a safety follow-up period of 8 weeks.

    Genentech, Inc. Sponsor
    Phase 2 Phase
    NCT02983227, GA30067, 2016-000498-19 Trial Identifier
    GDC-0853 Treatments
    Rheumatoid Arthritis Condition
    Official Title

    A Phase II Open-Label Extension Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Rheumatoid Arthritis

    Eligibility Criteria

    All Gender
    ≥ 18 Years & ≤ 76 Years Age
    No Healthy Volunteers
    Inclusion Criteria
    • Completion of treatment as specified in Study GA29350, including completion of the Day 84 study visit assessments
    • Acceptable safety and tolerability during Study GA29350 as determined by the investigator or Medical Monitor
    • Have not received any prohibited medications in Study GA29350
    • While taking methotrexate, must be willing to receive oral folic acid (at least 5 milligrams per week [mg/week])
    • If receiving oral corticosteroids (less than or equal to [</=] 10 milligrams per day [mg/day] prednisone or equivalent) and/or non-steroidal anti‑inflammatory drugs, doses have remained stable for the duration of Study GA29350
    Exclusion Criteria
    • Met protocol defined treatment stopping criteria during Study GA29350
    • Treatment with any investigational agent (i.e., other than study drug) or live/attenuated vaccine or any other prohibited medication during Study GA29350 or since the last administration of study drug in Study GA29350
    • In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA29350), significant, uncontrolled comorbidity that would increase the risk to the participant in Study GA30067
    • Pregnant or lactating, or intending to become pregnant during the study
    • Participants who experienced a de novo or reactivated serious viral infection such as hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) during the Phase II Study GA29350
    • Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during the Phase II Study GA29350
    • Participants who developed a malignancy during the Phase II Study GA29350
    • 12-lead electrocardiogram (ECG) on Day 84 in Study GA29350 that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
    • Current treatment with medications that are well known to prolong the QT interval

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