Clinical trial NCT02983227: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-06
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Day 1 up until 8 weeks after the last dose of study drug (up to 1 year, 2 months)
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving ACR50 Response up to Week 12
timeFrame: Weeks 4, 8 and 12
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 52
measure: Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 52
measure: Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 52
measure: Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR)
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36 and 52
measure: Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28)
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Percentage of Participants With Low Disease Activity (LDA) Based on DAS28
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Percentage of Participants With ACR/EULAR Remission
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in Simplified Disease Activity Index (SDAI)
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in Clinical Disease Activity Index (CDAI)
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in Tender/Painful Joint Count Based on 68 Joints
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in Swollen Joint Count Based on 66 Joints
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in Patient's Global Assessment of Arthritis, Using VAS Score
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in Physician's Global Assessment of Arthritis, Using VAS Score
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in C-Reactive Protein (CRP) Levels
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Weeks 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components
timeFrame: Weeks 12, 24 and 52
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
timeFrame: Weeks 12, 24 and 52
measure: Area Under the Concentration Time Curve (AUC) of GDC-0853 at Steady State (AUC,ss)
timeFrame: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination
measure: Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)
timeFrame: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination
measure: Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)
timeFrame: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination
measure: Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)
timeFrame: Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: Fullerton
country: United States
facility: Saint Jude Heritage Medical Grp
state: California
city: Boca Raton
country: United States
facility: RASF-Clinical Research Center
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Greensboro
country: United States
facility: Medication Management
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science Uni
state: Oregon
city: Dallas
country: United States
facility: Metroplex Clinical Research Centre
state: Texas
city: Dallas
country: United States
facility: Baylor Research Inst.
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clinicas-Mar del Plata
city: Buenos Aires
country: Argentina
facility: APRILLUS
city: Buenos Aires
country: Argentina
facility: Instituto centenario
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro de Investigacion en Enfermedades Reumaticas CIER
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Expertia S.A- Mautalen Salud e Investigación
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: CCBR - Buenos Aires - AR; AxisMed SRL
city: Cordoba
country: Argentina
facility: ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar Del Plata
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
city: San Miguel
country: Argentina
facility: Centro Medico Privado de Reumatologia; Reumathology
city: Goiânia
country: Brazil
facility: CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica
state: GO
city: Juiz de Fora
country: Brazil
facility: CMiP - Centro Mineiro de Pesquisa*X*
state: MG
city: Curtiba
country: Brazil
facility: Centro de Estudos em Terapias Inovadoras - CETI
state: PR
city: Rio de Janeiro
country: Brazil
facility: CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
state: RJ
city: Porto Alegre
country: Brazil
facility: LMK Serviços Médicos S/S
state: RS
city: Campinas
country: Brazil
facility: CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
state: SP
city: Sao Paulo
country: Brazil
facility: IMA Brasil - Instituto de Medicina Avancada
state: SP
city: Plovdiv
country: Bulgaria
facility: MHAT "Eurohospital" - Plovdiv, OOD; Internal Department
city: Plovdiv
country: Bulgaria
facility: UMHAT "Kaspela", EOOD
city: Sevlievo
country: Bulgaria
facility: Medizinski Zentrar-1-Sevlievo EOOD
city: Sliven
country: Bulgaria
facility: MHAT "Hadzhi Dimitar", OOD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD
city: Sofia
country: Bulgaria
facility: NMTH "Tsar Boris III"
city: Sofia
country: Bulgaria
facility: DCC "Alexandrovska", EOOD; Clinic of Neurology
city: Sofia
country: Bulgaria
facility: MC "Synexus - Sofia", EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "SofiaMed", OOD; Department of Neurology
city: Barranquilla
country: Colombia
facility: Centro de Investigacion Medico Asistencial S.A.S
city: Bogota
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
city: Bogota
country: Colombia
facility: Riesgo de Fractura S.A.
city: Cuernavaca
country: Mexico
facility: Consultorio Medico en Fundacion el Hospitalito de morelos A.C.
state: Morelos
city: Merida
country: Mexico
facility: Centro de Investigacion en Reumatologia
state: Yucatan
city: Cuernavaca
country: Mexico
facility: Consultorio Particular del Dr. Miguel Cortes Hernandez
city: Culiacan
country: Mexico
facility: Centro de Investigacion de Tratam Innovadores de Sin SC
city: Mexicali
country: Mexico
facility: Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis
city: Mexico
country: Mexico
facility: Centro de Investigacion Clínica GRAMEL S.C
city: Queretaro
country: Mexico
facility: Policlinica Medica de Queretaro S.C.
city: Tlalnepantla
country: Mexico
facility: Clinical Research Institute
city: Torreon
country: Mexico
facility: Unidad de Enfermedades Reumaticas y Cronicodegenerativas
city: Bialystok
country: Poland
facility: NZOZ ZDROWIE Osteo-Medic
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice I
city: Lodz
country: Poland
facility: CCBR - Lodz - PL
city: Olsztyn
country: Poland
facility: ETYKA Osrodek Badan Kliniczynch
city: Poznan
country: Poland
facility: Ai Centrum Medyczne Sp. Z O.O Sp.K.
city: Warszawa
country: Poland
facility: Medycyna Kliniczna
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED
city: Zamosc
country: Poland
facility: KO-MED Centra Kliniczne Zamosc
city: Yaroslavl
country: Russian Federation
facility: SBIH of Yaroslavl region " Regional Clinical Hospital "; Therapy
state: Jaroslavl
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: SBIH of Moscow "City Clinical Hospital # 1 n. a. N. I. Pirogov"
state: Moskovskaja Oblast
city: Saint-Petersburg
country: Russian Federation
facility: SPb SBIH "Clinical Rheumatological Hospital # 25"
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: Sanavita LLC
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: LLC Medical Sanitary Unit
state: Sankt Petersburg
city: Yekaterinburg
country: Russian Federation
facility: Center of Family Medicine LC
state: Sankt Petersburg
city: Yaroslavl
country: Russian Federation
facility: SBHI of Yaroslavl Region Clinical Hospital #3
state: Volgograd
city: Chelyabinsk
country: Russian Federation
facility: SMMIH "Chelyabinsk Regional Clinical Hospital"
state: Voronez
city: Kemerovo
country: Russian Federation
facility: SAHI of Kem. "Regional Clinical Hospital for War Veterans"
city: Korolev, Moscow Region
country: Russian Federation
facility: OOO Family Polyclinic
city: Moscow
country: Russian Federation
facility: Practical Medicine
city: Novosibirsk
country: Russian Federation
facility: Limited Liability Company "Centre of Medical Common Practice"
city: Omsk
country: Russian Federation
facility: Ultramed
city: Saratov
country: Russian Federation
facility: SEIHPE Saratov State Medical University n.a. V.I. Razumovskiy
city: Smolensk
country: Russian Federation
facility: NIH "Departmental Hospital on Station Smolensk of OJSC "Russian Railways"
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Ulyanovsk
country: Russian Federation
facility: SHI Ulyanovsk Reg Clinical Hospital
city: Vladivostok
country: Russian Federation
facility: Territorial Clinical Hospital #2
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Niska Banja
country: Serbia
facility: Institute of Treatment and Rehabilitation "Niska Banja"
city: Novi Sad
country: Serbia
facility: Special hospital for rheumatic diseases Novi Sad
city: Sabac
country: Serbia
facility: General Hospital "Dr Laza K. Lazarevic" Sabac
city: Kyiv
country: Ukraine
facility: MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
state: Chernihiv Governorate
city: Kharkiv
country: Ukraine
facility: CI of Healthcare Kharkiv CCH #8 Dept of Therapy Kharkiv MA of PGE of MOHU
state: Kharkiv Governorate
city: Ternopil
country: Ukraine
facility: CI of TRC
state: Kherson Governorate
city: Ivano-Frankivsk
country: Ukraine
facility: Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Medical Center of Revmotsentr LLC
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Medical Center of Limited Liability Company Medical Clinic Blagomed
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
state: KIEV Governorate
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital Dept of Rehmuaatology D. Halytskyi Lviv NMU
state: KIEV Governorate
city: Lviv
country: Ukraine
facility: CH of State Border Service of Ukraine (Military Base 2522); Dept of Therapy, D.Halytskyi Lviv NMU
state: KIEV Governorate
city: Uzhgorod
country: Ukraine
facility: A.Novak Transcarpathian Regional Clinical Hospital
state: KIEV Governorate
city: Vinnytsia
country: Ukraine
facility: National Pirogov Memorial Medical University
state: Podolia Governorate
city: Dnipro
country: Ukraine
facility: Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology
state: Tavria Okruha
city: Zaporizhzhia
country: Ukraine
facility: City Clinical Hospital #9 Dept of Therapy SI Zaporizhzhia MA of PGE of MoHU
state: Tavria Okruha
city: Zaporizhzhia
country: Ukraine
facility: CI City Hospital #1
state: Tavria Okruha
city: Lutsk
country: Ukraine
facility: CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
state: Volhynian Governorate
city: Kharkiv
country: Ukraine
facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
city: Poltava
country: Ukraine
facility: M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA
city: Zaporizhzhia
country: Ukraine
facility: CI City Hospital #7
city: Zaporizhzhia
country: Ukraine
facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: