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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: GDC-0853

• Study Type: Interventional
• Enrollment (Actual): 496
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, B7600FZN
    • Instituto de Investigaciones Clinicas-Mar del Plata
  • Buenos Aires, Argentina, C1194AAO
    • APRILLUS
  • Buenos Aires, Argentina, C1204AAD
    • Instituto Centenario
  • Ciudad Autonoma Buenos Aires, Argentina, C1055AAF
    • Centro de Investigacion en Enfermedades Reumaticas CIER
  • Ciudad Autonoma Buenos Aires, Argentina, C1128AAE
    • Expertia S.A- Mautalén Salud e Investigación
  • Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
    • CCBR - Buenos Aires - AR; AxisMed SRL
  • Cordoba, Argentina, X5000BNB
    • ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas
  • Mar del Plata, Argentina, B7600DHK
    • Centro de Investigaciones Médicas Mar del Plata
  • Rosario, Argentina, S2000CVD
    • Instituto de Investigaciones Clinicas
  • San Juan, Argentina, 5400
    • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
  • San Miguel, Argentina, T4000AXL
    • Centro Medico Privado de Reumatologia; Reumathology
• Brazil
  • GO
    • Goiânia, GO, Brazil, 74110-120
      • CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica
  • MG
    • Juiz de Fora, MG, Brazil, 36010-570
      • CMiP - Centro Mineiro de Pesquisa*X*
  • PR
    • Curtiba, PR, Brazil, 80030-110
      • Centro de Estudos em Terapias Inovadoras - CETI
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21941-913
      • CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
  • RS
    • Porto Alegre, RS, Brazil, 90480-000
      • LMK Serviços Médicos S/S
  • SP
    • Campinas, SP, Brazil, 13087-567
      • CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
    • Sao Paulo, SP, Brazil, 05437-000
      • IMA Brasil - Instituto de Medicina Avançada
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • MHAT "Eurohospital" - Plovdiv, OOD; Internal Department
  • Plovdiv, Bulgaria, 4002
    • UMHAT "Kaspela", EOOD
  • Sevlievo, Bulgaria, 5400
    • Medizinski Zentrar-1-Sevlievo EOOD
  • Sliven, Bulgaria, 8800
    • MHAT "Hadzhi Dimitar", OOD
  • Sofia, Bulgaria, 1233
    • NMTH "Tsar Boris III"
  • Sofia, Bulgaria, 1000
    • Medical Center Excelsior OOD
  • Sofia, Bulgaria, 1431
    • DCC "Alexandrovska", EOOD; Clinic of Neurology
  • Sofia, Bulgaria, 1784
    • MC "Synexus - Sofia", EOOD
  • Sofia, Bulgaria, 1797
    • UMHAT "SofiaMed", OOD; Department of Neurology
• Colombia
  • Barranquilla, Colombia, 80020
    • Centro de Investigacion Medico Asistencial S.A.S
  • Bogota, Colombia, 110221
    • Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
  • Bogota, Colombia, 110221
    • Riesgo de Fractura S.A.
• Mexico
  • Cuernavaca, Mexico, 62290
    • Consultorio Particular del Dr. Miguel Cortes Hernandez
  • Culiacan, Mexico, 80230
    • Centro de Investigacion de Tratam Innovadores de Sin SC
  • Mexicali, Mexico, 21100
    • Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis
  • Mexico, Mexico, 03720
    • Centro de Investigacion Clínica GRAMEL S.C
  • Queretaro, Mexico, 76000
    • Policlinica Medica de Queretaro S.C.
  • Tlalnepantla, Mexico, 54055
    • Clinical Research Institute
  • Torreon, Mexico, 27000
    • Unidad de Enfermedades Reumaticas y Cronicodegenerativas
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62170
      • Consultorio Medico en Fundacion el Hospitalito de morelos A.C.
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Centro de Investigacion en Reumatologia
• Poland
  • Bialystok, Poland, 15-351
    • Nzoz Zdrowie Osteo-Medic
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
  • Katowice, Poland, 40-081
    • Centrum Medyczne Pratia Katowice I
  • Lodz, Poland, 90-368
    • CCBR - Lodz - PL
  • Olsztyn, Poland, 10-117
    • ETYKA Osrodek Badan Kliniczynch
  • Poznan, Poland, 61-113
    • Ai Centrum Medyczne Sp. Z O.O Sp.K.
  • Warszawa, Poland, 00-660
    • Medycyna Kliniczna
  • Warszawa, Poland, 03-291
    • Centrum Medyczne AMED
  • Zamosc, Poland, 22400
    • KO-MED Centra Kliniczne Zamosc
• Russian Federation
  • Kemerovo, Russian Federation, 650000
    • SAHI of Kem. "Regional Clinical Hospital for War Veterans"
  • Korolev, Moscow Region, Russian Federation, 141060
    • OOO Family Polyclinic
  • Moscow, Russian Federation, 115404
    • Practical Medicine
  • Novosibirsk, Russian Federation, 630091
    • Limited Liability Company "Centre of Medical Common Practice"
  • Omsk, Russian Federation, 644024
    • Ultramed
  • Saratov, Russian Federation, 410012
    • SEIHPE Saratov State Medical University n.a. V.I. Razumovskiy
  • Smolensk, Russian Federation, 214025
    • NIH "Departmental Hospital on Station Smolensk of OJSC "Russian Railways"
  • Tomsk, Russian Federation, 634050
    • Siberian State Medical University
  • Ulyanovsk, Russian Federation, 432063
    • SHI Ulyanovsk Reg Clinical Hospital
  • Vladivostok, Russian Federation, 690035
    • Territorial Clinical Hospital #2
  • Jaroslavl
    • Yaroslavl, Jaroslavl, Russian Federation, 150062
      • SBIH of Yaroslavl region " Regional Clinical Hospital "; Therapy
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 115522
      • Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
    • Moscow, Moskovskaja Oblast, Russian Federation, 119049
      • SBIH of Moscow "City Clinical Hospital # 1 n. a. N. I. Pirogov"
  • Sankt Petersburg
    • Saint-Petersburg, Sankt Petersburg, Russian Federation, 190068
      • SPb SBIH "Clinical Rheumatological Hospital # 25"
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 195257
      • Sanavita LLC
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 196066
      • LLC Medical Sanitary Unit
    • Yekaterinburg, Sankt Petersburg, Russian Federation, 620043
      • Center of Family Medicine LC
  • Volgograd
    • Yaroslavl, Volgograd, Russian Federation, 150051
      • SBHI of Yaroslavl Region Clinical Hospital #3
  • Voronez
    • Chelyabinsk, Voronez, Russian Federation, 454076
      • SMMIH "Chelyabinsk Regional Clinical Hospital"
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Niska Banja, Serbia, 18205
    • Institute of Treatment and Rehabilitation "Niska Banja"
  • Novi Sad, Serbia, 21000
    • Special Hospital For Rheumatic Diseases Novi Sad
  • Sabac, Serbia, 15000
    • General Hospital "Dr Laza K. Lazarevic" Sabac
• Ukraine
  • Kharkiv, Ukraine, 61039
    • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
  • Kyiv, Ukraine, 02232
    • CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
  • Poltava, Ukraine, 36011
    • M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA
  • Zaporizhzhia, Ukraine, 69118
    • CI City Hospital #7
  • Zaporizhzhia, Ukraine, 69600
    • CI Zaporizhzhia Regional Clinical Hospital of ZRC
  • Chernihiv Governorate
    • Kyiv, Chernihiv Governorate, Ukraine, 01601
      • MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
  • KIEV Governorate
    • Ivano-Frankivsk, KIEV Governorate, Ukraine, 76008
      • Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
    • Kyiv, KIEV Governorate, Ukraine, 03680
      • SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
    • Kyiv, KIEV Governorate, Ukraine, 04070
      • Medical Center of Revmotsentr LLC
    • Kyiv, KIEV Governorate, Ukraine, 1023
      • Medical Center of Limited Liability Company Medical Clinic Blagomed
    • Kyiv, KIEV Governorate, Ukraine, 2091
      • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
    • Lviv, KIEV Governorate, Ukraine, 79010
      • Lviv Regional Clinical Hospital Dept of Rehmuaatology D. Halytskyi Lviv NMU
    • Lviv, KIEV Governorate, Ukraine, 79014
      • CH of State Border Service of Ukraine (Military Base 2522); Dept of Therapy, D.Halytskyi Lviv NMU
    • Uzhgorod, KIEV Governorate, Ukraine, 88018
      • A.Novak Transcarpathian Regional Clinical Hospital
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61176
      • CI of Healthcare Kharkiv CCH #8 Dept of Therapy Kharkiv MA of PGE of MOHU
  • Kherson Governorate
    • Ternopil, Kherson Governorate, Ukraine, 46002
      • CI of TRC
  • Podolia Governorate
    • Vinnytsia, Podolia Governorate, Ukraine, 21018
      • National Pirogov Memorial Medical University
  • Tavria Okruha
    • Dnipro, Tavria Okruha, Ukraine, 49008
      • Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology
    • Zaporizhzhia, Tavria Okruha, Ukraine, 69065
      • City Clinical Hospital #9 Dept of Therapy SI Zaporizhzhia MA of PGE of MoHU
    • Zaporizhzhia, Tavria Okruha, Ukraine, 69104
      • CI City Hospital #1
  • Volhynian Governorate
    • Lutsk, Volhynian Governorate, Ukraine, 43024
      • CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arizona Arthritis & Rheumatology Associates, P.C.
  • California
    • Covina, California, United States, 91723
      • Medvin Clinical Research
    • El Cajon, California, United States, 92020
      • TriWest Research Associates, LLC
    • Fullerton, California, United States, 92835
      • Saint Jude Heritage Medical Grp
  • Florida
    • Boca Raton, Florida, United States, 33486
      • RASF-Clinical Research Center
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Medication Management
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science Uni
  • Texas
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Centre
    • Dallas, Texas, United States, 75246
      • Baylor Research Inst.
    • Houston, Texas, United States, 77089
      • Accurate Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: GDC-0853; GDC-0853 was administered orally at a dose of 200mg, as per the dosing schedules described above.; Other Names: RO7010939
Experimental: 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.	Drug: GDC-0853; GDC-0853 was administered orally at a dose of 200mg, as per the dosing schedules described above.; Other Names: RO7010939

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving ACR50 Response up to Week 12	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].	Weeks 4, 8 and 12
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	ACR20 response is defined as a ≥ 20% 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]	Weeks 4, 8, 12, 24, 36 and 52
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	ACR70 response is defined as a ≥ 70% 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].	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)	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.	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)	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.	Baseline, Weeks 4, 8, 12, 24, 36 and 52
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR)	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.	Baseline, Weeks 4, 8, 12, 24, 36 and 52
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR)	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.	Baseline, Weeks 4, 8, 12, 24, 36 and 52
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28)	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control.	Weeks 4, 8, 12, 24, 36 and 52
Percentage of Participants With Low Disease Activity (LDA) Based on DAS28	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDAS is defined as DAS28 ≤ 3.2	Weeks 4, 8, 12, 24, 36 and 52
Percentage of Participants With ACR/EULAR Remission	Assessed according to the Boolean based definition (tender joint count =<1, swollen joint count =<1, C-reactive Protein (CRP) =<1, and patient global assessment =<1)	Weeks 4, 8, 12, 24, 36 and 52
Change From Baseline in Simplified Disease Activity Index (SDAI)	Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity	Weeks 4, 8, 12, 24, 36 and 52
Change From Baseline in Clinical Disease Activity Index (CDAI)	CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest. Negative values indicate improvement/reduction in RA disease activity.	Weeks 4, 8, 12, 24, 36 and 52
Change From Baseline in Tender/Painful Joint Count Based on 68 Joints	Tender Joint Count: a total of 68 joints will be assessed for tenderness. Each joint is assessed for the presence/absence of tenderness. 68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.	Weeks 4, 8, 12, 24, 36 and 52
Change From Baseline in Swollen Joint Count Based on 66 Joints	Swollen Joint Count: a total of 66 joints will be assessed for swelling. Each joint is assessed for the presence/absence of swelling. 66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.	Weeks 4, 8, 12, 24, 36 and 52
Change From Baseline in Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score	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	Weeks 4, 8, 12, 24, 36 and 52
Change From Baseline in Patient's Global Assessment of Arthritis, Using VAS Score	Participant-assessed arthritis pain was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of arthritis pain (0 mm=none; 100 mm=very severe). Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest, where negative change indicated a decrease in participant-assessed arthritis pain.	Weeks 4, 8, 12, 24, 36 and 52
Change From Baseline in Physician's Global Assessment of Arthritis, Using VAS Score	Physician's assessment of participant's disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's assessment of the participant's disease activity (0 mm=very good; 100 mm=very poor). Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest, where negative change from baseline indicated an improvement in physician-assessed disease activity.	Weeks 4, 8, 12, 24, 36 and 52
Change From Baseline in C-Reactive Protein (CRP) Levels	C-reactive protein is a biological marker of inflammation and is measured in milligrams per decilitre (mg/dL)	Weeks 4, 8, 12, 24, 36 and 52
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score	The Stanford Health Assessment Questionnaire disability index is a patient-reported outcome used to assess difficulty in performing activities of daily living. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. To respond to each question, a four-level response with higher scores showing larger functional limitations, was chosen. Scoring is as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. The composite HAQ-DI score is the mean of the eight domain scores and the score ranges from 0 (no functional impairment) to 3 (maximum functional impairment). A negative change from baseline indicates improvement.	Weeks 4, 8, 12, 24, 36 and 52
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components	The 36-Item Short Form Health Survey (SF-36v2) is a questionnaire used to assess functional health and well-being and consists of eight domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The SF-36v2 is summarized into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. The PCS and MCS scores range from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.	Weeks 12, 24 and 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score	The FACIT-Fatigue Scale consists of 13 items designed to measure the degree of fatigue experienced by the patient in the previous 7 days. For each question, there are five possible responses: 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). A total fatigue score is calculated by summing all items, and possible total scores range from 0 (maximum fatigue) to 52 (no fatigue). A positive change from baseline indicates an improvement in the patient's fatigue (less fatigue).	Weeks 12, 24 and 52
Area Under the Concentration Time Curve (AUC) of GDC-0853 at Steady State (AUC,ss)	Population PK model estimated AUC of GDC-0853 at steady-state. AUC was measured in Nanograms (ng) per millilitre(mL)*hour (hr).	Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination
Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)	Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss).	Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination
Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)	Population PK model estimated plasma decay half life of GDC-0853 at steady-state.	Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination
Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)	Population PK model estimated apparent oral clearance of GDC-0853 at steady-state.	Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2016
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (Estimate): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: GA30067; 2016-000498-19 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No