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
NCT ID: NCT02983227
Last Updated: 2020-08-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
496 participants
INTERVENTIONAL
2016-11-30
2019-07-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
NCT02833350
An Open-label Study of GC012F in Rheumatoid Arthritis.
NCT07315503
A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis
NCT01830985
Safety and Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Repeat Doses of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)
NCT02858492
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients
NCT02089087
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GDC-0853 (200mg BID) Cohort 1
Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.
GDC-0853
GDC-0853 was administered orally at a dose of 200mg, as per the dosing schedules described above.
GDC-0853 (200mg BID) Cohort 2
Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.
GDC-0853
GDC-0853 was administered orally at a dose of 200mg, as per the dosing schedules described above.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GDC-0853
GDC-0853 was administered orally at a dose of 200mg, as per the dosing schedules described above.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
76 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
RASF-Clinical Research Center
Boca Raton, Florida, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Medication Management
Greensboro, North Carolina, United States
Oregon Health & Science Uni
Portland, Oregon, United States
Metroplex Clinical Research Centre
Dallas, Texas, United States
Baylor Research Inst.
Dallas, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Instituto de Investigaciones Clinicas-Mar del Plata
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
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, , Argentina
Instituto de Investigaciones Clinicas
Rosario, , 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 X; Pesquisa Clinica
Goiânia, Goiás, Brazil
CMiP - Centro Mineiro de Pesquisa*X*
Juiz de Fora, Minas Gerais, Brazil
Centro de Estudos em Terapias Inovadoras - CETI
Curtiba, Paraná, Brazil
CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
Rio de Janeiro, Rio de Janeiro, 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
IMA Brasil - Instituto de Medicina Avancada
São Paulo, São Paulo, Brazil
MHAT "Eurohospital" - Plovdiv, OOD; Internal Department
Plovdiv, , Bulgaria
UMHAT "Kaspela", EOOD
Plovdiv, , 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
DCC "Alexandrovska", EOOD; Clinic of Neurology
Sofia, , Bulgaria
MC "Synexus - Sofia", EOOD
Sofia, , Bulgaria
UMHAT "SofiaMed", OOD; Department of Neurology
Sofia, , Bulgaria
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, , Colombia
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
Bogotá, , Colombia
Riesgo de Fractura S.A.
Bogotá, , Colombia
Consultorio Medico en Fundacion el Hospitalito de morelos A.C.
Cuernavaca, Morelos, Mexico
Centro de Investigacion en Reumatologia
Mérida, Yucatán, Mexico
Consultorio Particular del Dr. Miguel Cortes Hernandez
Cuernavaca, , Mexico
Centro de Investigacion de Tratam Innovadores de Sin SC
Culiacán, , Mexico
Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis
Mexicali, , Mexico
Centro de Investigacion Clínica GRAMEL S.C
México, , Mexico
Policlinica Medica de Queretaro S.C.
Querétaro, , Mexico
Clinical Research Institute
Tlalnepantla, , Mexico
Unidad de Enfermedades Reumaticas y Cronicodegenerativas
Torreón, , Mexico
NZOZ ZDROWIE Osteo-Medic
Bialystok, , Poland
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
Bydgoszcz, , Poland
Centrum Medyczne Pratia Katowice I
Katowice, , Poland
CCBR - Lodz - PL
Lodz, , Poland
ETYKA Osrodek Badan Kliniczynch
Olsztyn, , Poland
Ai Centrum Medyczne Sp. Z O.O Sp.K.
Poznan, , Poland
Medycyna Kliniczna
Warsaw, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
KO-MED Centra Kliniczne Zamosc
Zamość, , Poland
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
SPb SBIH "Clinical Rheumatological Hospital # 25"
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
SBIH of Yaroslavl region " Regional Clinical Hospital "; Therapy
Yaroslavl, Yaroslavl Oblast, 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
SEIHPE Saratov State Medical University n.a. V.I. Razumovskiy
Saratov, , Russia
NIH "Departmental Hospital on Station Smolensk of OJSC "Russian Railways"
Smolensk, , Russia
Siberian State Medical University
Tomsk, , Russia
SHI Ulyanovsk Reg Clinical Hospital
Ulyanovsk, , Russia
Territorial Clinical Hospital #2
Vladivostok, , Russia
Institute of Rheumatology
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 "Dr Laza K. Lazarevic" Sabac
Šabac, , Serbia
MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
Kyiv, Chernihiv Governorate, Ukraine
CI of Healthcare Kharkiv CCH #8 Dept of Therapy Kharkiv MA of PGE of MOHU
Kharkiv, Kharkiv Governorate, Ukraine
CI of TRC
Ternopil, Kherson Governorate, Ukraine
Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, KIEV Governorate, Ukraine
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
Kyiv, KIEV Governorate, Ukraine
Medical Center of Revmotsentr LLC
Kyiv, KIEV Governorate, Ukraine
Medical Center of Limited Liability Company Medical Clinic Blagomed
Kyiv, KIEV Governorate, Ukraine
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
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
National Pirogov Memorial Medical University
Vinnytsia, Podolia Governorate, Ukraine
Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology
Dnipro, Tavria Okruha, Ukraine
City Clinical Hospital #9 Dept of Therapy SI Zaporizhzhia MA of PGE of MoHU
Zaporizhzhia, Tavria Okruha, Ukraine
CI City Hospital #1
Zaporizhzhia, Tavria Okruha, Ukraine
CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
Lutsk, Volhynian Governorate, Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, , Ukraine
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
Kyiv, , Ukraine
M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA
Poltava, , Ukraine
CI City Hospital #7
Zaporizhzhia, , Ukraine
CI Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporizhzhia, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-000498-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA30067
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.