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

NCT02983227 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: GA300672016-000498-19
• Study Type: interventional
• Target: 496
• Locations: 10 countries
• Sites: 104

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Adverse Events (AEs)

  An Adverse Event (AE) 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.

  Day 1 up until 8 weeks after the last dose of study drug (up to 1 year, 2 months)

• Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 52

  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 \[either C-reactive protein or Erythrocyte Sedimentation Rate\].

  Week 52

Secondary Outcomes (25)

• Percentage of Participants Achieving ACR50 Response up to Week 12

  Weeks 4, 8 and 12

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

  Weeks 4, 8, 12, 24, 36 and 52

• Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

  Weeks 4, 8, 12, 24, 36 and 52

• Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP)

  Baseline, Weeks 4, 8, 12, 24, 36 and 52

• Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP)

  Baseline, Weeks 4, 8, 12, 24, 36 and 52

Study Arms (2)

GDC-0853 (200mg BID) Cohort 1

EXPERIMENTAL

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.

Drug: GDC-0853

GDC-0853 (200mg BID) Cohort 2

EXPERIMENTAL

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.

Drug: GDC-0853

Interventions

GDC-0853 DRUG

GDC-0853 was administered orally at a dose of 200mg, as per the dosing schedules described above.

Also known as: RO7010939

GDC-0853 (200mg BID) Cohort 1; GDC-0853 (200mg BID) Cohort 2

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (104)

Arizona Arthritis & Rheumatology Associates, P.C.

Glendale, Arizona, 85306, United States

Location

Medvin Clinical Research

Covina, California, 91723, United States

Location

TriWest Research Associates, LLC

El Cajon, California, 92020, United States

Location

Saint Jude Heritage Medical Grp

Fullerton, California, 92835, United States

Location

RASF-Clinical Research Center

Boca Raton, Florida, 33486, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Medication Management

Greensboro, North Carolina, 27408, United States

Location

Oregon Health & Science Uni

Portland, Oregon, 97239, United States

Location

Metroplex Clinical Research Centre

Dallas, Texas, 75231, United States

Location

Baylor Research Inst.

Dallas, Texas, 75246, United States

Location

Accurate Clinical Research

Houston, Texas, 77089, United States

Location

Instituto de Investigaciones Clinicas-Mar del Plata

Buenos Aires, B7600FZN, Argentina

Location

APRILLUS

Buenos Aires, C1194AAO, Argentina

Location

Instituto centenario

Buenos Aires, C1204AAD, Argentina

Location

Centro de Investigacion en Enfermedades Reumaticas CIER

Ciudad Autonoma Buenos Aires, C1055AAF, Argentina

Location

Expertia S.A- Mautalen Salud e Investigación

Ciudad Autonoma Buenos Aires, C1128AAE, Argentina

Location

CCBR - Buenos Aires - AR; AxisMed SRL

Ciudad Autonoma Buenos Aires, C1430CKE, Argentina

Location

ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas

Córdoba, X5000BNB, Argentina

Location

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, B7600DHK, Argentina

Location

Instituto de Investigaciones Clinicas

Rosario, S2000CVD, Argentina

Location

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, 5400, Argentina

Location

Centro Medico Privado de Reumatologia; Reumathology

San Miguel, T4000AXL, Argentina

Location

CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica

Goiânia, Goiás, 74110-120, Brazil

Location

CMiP - Centro Mineiro de Pesquisa*X*

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Centro de Estudos em Terapias Inovadoras - CETI

Curtiba, Paraná, 80030-110, Brazil

Location

CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

LMK Serviços Médicos S/S

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

Campinas, São Paulo, 13087-567, Brazil

Location

IMA Brasil - Instituto de Medicina Avancada

São Paulo, São Paulo, 05437-000, Brazil

Location

MHAT "Eurohospital" - Plovdiv, OOD; Internal Department

Plovdiv, 4002, Bulgaria

Location

UMHAT "Kaspela", EOOD

Plovdiv, 4002, Bulgaria

Location

Medizinski Zentrar-1-Sevlievo EOOD

Sevlievo, 5400, Bulgaria

Location

MHAT "Hadzhi Dimitar", OOD

Sliven, 8800, Bulgaria

Location

Medical Center Excelsior OOD

Sofia, 1000, Bulgaria

Location

NMTH "Tsar Boris III"

Sofia, 1233, Bulgaria

Location

DCC "Alexandrovska", EOOD; Clinic of Neurology

Sofia, 1431, Bulgaria

Location

MC "Synexus - Sofia", EOOD

Sofia, 1784, Bulgaria

Location

UMHAT "SofiaMed", OOD; Department of Neurology

Sofia, 1797, Bulgaria

Location

Centro de Investigacion Medico Asistencial S.A.S

Barranquilla, 80020, Colombia

Location

Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM

Bogotá, 110221, Colombia

Location

Riesgo de Fractura S.A.

Bogotá, 110221, Colombia

Location

Consultorio Medico en Fundacion el Hospitalito de morelos A.C.

Cuernavaca, Morelos, 62170, Mexico

Location

Centro de Investigacion en Reumatologia

Mérida, Yucatán, 97070, Mexico

Location

Consultorio Particular del Dr. Miguel Cortes Hernandez

Cuernavaca, 62290, Mexico

Location

Centro de Investigacion de Tratam Innovadores de Sin SC

Culiacán, 80230, Mexico

Location

Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis

Mexicali, 21100, Mexico

Location

Centro de Investigacion Clínica GRAMEL S.C

México, 03720, Mexico

Location

Policlinica Medica de Queretaro S.C.

Querétaro, 76000, Mexico

Location

Clinical Research Institute

Tlalnepantla, 54055, Mexico

Location

Unidad de Enfermedades Reumaticas y Cronicodegenerativas

Torreón, 27000, Mexico

Location

NZOZ ZDROWIE Osteo-Medic

Bialystok, 15-351, Poland

Location

Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

Bydgoszcz, 85-168, Poland

Location

Centrum Medyczne Pratia Katowice I

Katowice, 40-081, Poland

Location

CCBR - Lodz - PL

Lodz, 90-368, Poland

Location

ETYKA Osrodek Badan Kliniczynch

Olsztyn, 10-117, Poland

Location

Ai Centrum Medyczne Sp. Z O.O Sp.K.

Poznan, 61-113, Poland

Location

Medycyna Kliniczna

Warsaw, 00-660, Poland

Location

Centrum Medyczne AMED

Warsaw, 03-291, Poland

Location

KO-MED Centra Kliniczne Zamosc

Zamość, 22400, Poland

Location

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

Moscow, Moscow Oblast, 115522, Russia

Location

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

Moscow, Moscow Oblast, 119049, Russia

Location

SPb SBIH "Clinical Rheumatological Hospital # 25"

Saint Petersburg, Sankt-Peterburg, 190068, Russia

Location

Sanavita LLC

Saint Petersburg, Sankt-Peterburg, 195257, Russia

Location

LLC Medical Sanitary Unit

Saint Petersburg, Sankt-Peterburg, 196066, Russia

Location

Center of Family Medicine LC

Yekaterinburg, Sankt-Peterburg, 620043, Russia

Location

SBHI of Yaroslavl Region Clinical Hospital #3

Yaroslavl, Volgograd Oblast, 150051, Russia

Location

SMMIH "Chelyabinsk Regional Clinical Hospital"

Chelyabinsk, Voronez, 454076, Russia

Location

SBIH of Yaroslavl region " Regional Clinical Hospital "; Therapy

Yaroslavl, Yaroslavl Oblast, 150062, Russia

Location

SAHI of Kem. "Regional Clinical Hospital for War Veterans"

Kemerovo, 650000, Russia

Location

OOO Family Polyclinic

Korolev, Moscow Region, 141060, Russia

Location

Practical Medicine

Moscow, 115404, Russia

Location

Limited Liability Company "Centre of Medical Common Practice"

Novosibirsk, 630091, Russia

Location

Ultramed

Omsk, 644024, Russia

Location

SEIHPE Saratov State Medical University n.a. V.I. Razumovskiy

Saratov, 410012, Russia

Location

NIH "Departmental Hospital on Station Smolensk of OJSC "Russian Railways"

Smolensk, 214025, Russia

Location

Siberian State Medical University

Tomsk, 634050, Russia

Location

SHI Ulyanovsk Reg Clinical Hospital

Ulyanovsk, 432063, Russia

Location

Territorial Clinical Hospital #2

Vladivostok, 690035, Russia

Location

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Institute of Treatment and Rehabilitation "Niska Banja"

Niška Banja, 18205, Serbia

Location

Special hospital for rheumatic diseases Novi Sad

Novi Sad, 21000, Serbia

Location

General Hospital "Dr Laza K. Lazarevic" Sabac

Šabac, 15000, Serbia

Location

MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE

Kyiv, Chernihiv Governorate, 01601, Ukraine

Location

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

Kharkiv, Kharkiv Governorate, 61176, Ukraine

Location

CI of TRC

Ternopil, Kherson Governorate, 46002, Ukraine

Location

Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU

Ivano-Frankivsk, KIEV Governorate, 76008, Ukraine

Location

SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU

Kyiv, KIEV Governorate, 03680, Ukraine

Location

Medical Center of Revmotsentr LLC

Kyiv, KIEV Governorate, 04070, Ukraine

Location

Medical Center of Limited Liability Company Medical Clinic Blagomed

Kyiv, KIEV Governorate, 1023, Ukraine

Location

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

Kyiv, KIEV Governorate, 2091, Ukraine

Location

Lviv Regional Clinical Hospital Dept of Rehmuaatology D. Halytskyi Lviv NMU

Lviv, KIEV Governorate, 79010, Ukraine

Location

CH of State Border Service of Ukraine (Military Base 2522); Dept of Therapy, D.Halytskyi Lviv NMU

Lviv, KIEV Governorate, 79014, Ukraine

Location

A.Novak Transcarpathian Regional Clinical Hospital

Uzhhorod, KIEV Governorate, 88018, Ukraine

Location

National Pirogov Memorial Medical University

Vinnytsia, Podolia Governorate, 21018, Ukraine

Location

Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology

Dnipro, Tavria Okruha, 49008, Ukraine

Location

City Clinical Hospital #9 Dept of Therapy SI Zaporizhzhia MA of PGE of MoHU

Zaporizhzhia, Tavria Okruha, 69065, Ukraine

Location

CI City Hospital #1

Zaporizhzhia, Tavria Okruha, 69104, Ukraine

Location

CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis

Lutsk, Volhynian Governorate, 43024, Ukraine

Location

GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

Kharkiv, 61039, Ukraine

Location

CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

Kyiv, 02232, Ukraine

Location

M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA

Poltava, 36011, Ukraine

Location

CI City Hospital #7

Zaporizhzhia, 69118, Ukraine

Location

CI Zaporizhzhia Regional Clinical Hospital of ZRC

Zaporizhzhia, 69600, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fenebrutinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 6, 2016
• Study Start: November 30, 2016
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: August 3, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-07

Locations

BR (7); AR (11); ME (9); BU (9); CO (3); RU (19); SE (5); UA (21); PL (9); US (11)