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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983227
• Other study ID #: GA30067
• Secondary ID: 2016-000498-19
• Status: Completed
• Phase: Phase 2
• Start date: November 30, 2016
• Est. completion date: July 17, 2019

Study information

• Verified date: July 2020
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Argentina	APRILLUS	Buenos Aires
Argentina	Instituto centenario	Buenos Aires
Argentina	Instituto de Investigaciones Clinicas-Mar del Plata	Buenos Aires
Argentina	CCBR - Buenos Aires - AR; AxisMed SRL	Ciudad Autonoma 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	ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas	Cordoba
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
Brazil	CAEP - Centro Avancado de Estudos e Pesquisas Ltda.	Campinas	SP
Brazil	Centro de Estudos em Terapias Inovadoras - CETI	Curtiba	PR
Brazil	CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica	Goiânia	GO
Brazil	CMiP - Centro Mineiro de Pesquisa*X*	Juiz de Fora	MG
Brazil	LMK Serviços Médicos S/S	Porto Alegre	RS
Brazil	CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.	Rio de Janeiro	RJ
Brazil	IMA Brasil - Instituto de Medicina Avancada	Sao Paulo	SP
Bulgaria	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	DCC "Alexandrovska", EOOD; Clinic of Neurology	Sofia
Bulgaria	MC "Synexus - Sofia", EOOD	Sofia
Bulgaria	Medical Center Excelsior OOD	Sofia
Bulgaria	NMTH "Tsar Boris III"	Sofia
Bulgaria	UMHAT "SofiaMed", OOD; Department of Neurology	Sofia
Colombia	Centro de Investigacion Medico Asistencial S.A.S	Barranquilla
Colombia	Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM	Bogota
Colombia	Riesgo de Fractura S.A.	Bogota
Mexico	Consultorio Medico en Fundacion el Hospitalito de morelos A.C.	Cuernavaca	Morelos
Mexico	Consultorio Particular del Dr. Miguel Cortes Hernandez	Cuernavaca
Mexico	Centro de Investigacion de Tratam Innovadores de Sin SC	Culiacan
Mexico	Centro de Investigacion en Reumatologia	Merida	Yucatan
Mexico	Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis	Mexicali
Mexico	Centro de Investigacion Clínica GRAMEL S.C	Mexico
Mexico	Policlinica Medica de Queretaro S.C.	Queretaro
Mexico	Clinical Research Institute	Tlalnepantla
Mexico	Unidad de Enfermedades Reumaticas y Cronicodegenerativas	Torreon
Poland	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	Centrum Medyczne AMED	Warszawa
Poland	Medycyna Kliniczna	Warszawa
Poland	KO-MED Centra Kliniczne Zamosc	Zamosc
Russian Federation	SMMIH "Chelyabinsk Regional Clinical Hospital"	Chelyabinsk	Voronez
Russian Federation	SAHI of Kem. "Regional Clinical Hospital for War Veterans"	Kemerovo
Russian Federation	OOO Family Polyclinic	Korolev, Moscow Region
Russian Federation	Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova	Moscow	Moskovskaja Oblast
Russian Federation	Practical Medicine	Moscow
Russian Federation	SBIH of Moscow "City Clinical Hospital # 1 n. a. N. I. Pirogov"	Moscow	Moskovskaja Oblast
Russian Federation	Limited Liability Company "Centre of Medical Common Practice"	Novosibirsk
Russian Federation	Ultramed	Omsk
Russian Federation	SPb SBIH "Clinical Rheumatological Hospital # 25"	Saint-Petersburg	Sankt Petersburg
Russian Federation	LLC Medical Sanitary Unit	Sankt-peterburg	Sankt Petersburg
Russian Federation	Sanavita LLC	Sankt-peterburg	Sankt Petersburg
Russian Federation	SEIHPE Saratov State Medical University n.a. V.I. Razumovskiy	Saratov
Russian Federation	NIH "Departmental Hospital on Station Smolensk of OJSC "Russian Railways"	Smolensk
Russian Federation	Siberian State Medical University	Tomsk
Russian Federation	SHI Ulyanovsk Reg Clinical Hospital	Ulyanovsk
Russian Federation	Territorial Clinical Hospital #2	Vladivostok
Russian Federation	SBHI of Yaroslavl Region Clinical Hospital #3	Yaroslavl	Volgograd
Russian Federation	SBIH of Yaroslavl region " Regional Clinical Hospital "; Therapy	Yaroslavl	Jaroslavl
Russian Federation	Center of Family Medicine LC	Yekaterinburg	Sankt Petersburg
Serbia	Institute of Rheumatology	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Institute of Treatment and Rehabilitation "Niska Banja"	Niska Banja
Serbia	Special hospital for rheumatic diseases Novi Sad	Novi Sad
Serbia	General Hospital "Dr Laza K. Lazarevic" Sabac	Sabac
Ukraine	Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology	Dnipro	Tavria Okruha
Ukraine	Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU	Ivano-Frankivsk	KIEV Governorate
Ukraine	CI of Healthcare Kharkiv CCH #8 Dept of Therapy Kharkiv MA of PGE of MOHU	Kharkiv	Kharkiv 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	Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"	Kyiv	KIEV Governorate
Ukraine	Medical Center of Limited Liability Company Medical Clinic Blagomed	Kyiv	KIEV Governorate
Ukraine	Medical Center of Revmotsentr LLC	Kyiv	KIEV Governorate
Ukraine	MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE	Kyiv	Chernihiv Governorate
Ukraine	SI NS? M.D. Strazhesko Institute of Cardiology of NAMSU	Kyiv	KIEV Governorate
Ukraine	CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis	Lutsk	Volhynian Governorate
Ukraine	CH of State Border Service of Ukraine (Military Base 2522); Dept of Therapy, D.Halytskyi Lviv NMU	Lviv	KIEV Governorate
Ukraine	Lviv Regional Clinical Hospital Dept of Rehmuaatology D. Halytskyi Lviv NMU	Lviv	KIEV Governorate
Ukraine	M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA	Poltava
Ukraine	CI of TRC	Ternopil	Kherson Governorate
Ukraine	A.Novak Transcarpathian Regional Clinical Hospital	Uzhgorod	KIEV Governorate
Ukraine	National Pirogov Memorial Medical University	Vinnytsia	Podolia Governorate
Ukraine	CI City Hospital #1	Zaporizhzhia	Tavria Okruha
Ukraine	CI City Hospital #7	Zaporizhzhia
Ukraine	CI Zaporizhzhia Regional Clinical Hospital of ZRC	Zaporizhzhia
Ukraine	City Clinical Hospital #9 Dept of Therapy SI Zaporizhzhia MA of PGE of MoHU	Zaporizhzhia	Tavria Okruha
United States	RASF-Clinical Research Center	Boca Raton	Florida
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Medvin Clinical Research	Covina	California
United States	Baylor Research Inst.	Dallas	Texas
United States	Metroplex Clinical Research Centre	Dallas	Texas
United States	TriWest Research Associates, LLC	El Cajon	California
United States	Saint Jude Heritage Medical Grp	Fullerton	California
United States	Arizona Arthritis & Rheumatology Associates, P.C.	Glendale	Arizona
United States	Medication Management	Greensboro	North Carolina
United States	Accurate Clinical Research	Houston	Texas
United States	Oregon Health & Science Uni	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Colombia,  Mexico,  Poland,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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