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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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GDC-0853

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arizona Arthritis & Rheumatology Associates, P.C.
Medvin Clinical Research
TriWest Research Associates, LLC
Saint Jude Heritage Medical Grp
RASF-Clinical Research Center
Clinical Research of West Florida
Medication Management
Oregon Health & Science Uni
Metroplex Clinical Research Centre
Baylor Research Inst.
Accurate Clinical Research
Instituto de Investigaciones Clinicas-Mar del Plata
APRILLUS
Instituto centenario
Centro de Investigacion en Enfermedades Reumaticas CIER
Expertia S.A- Mautalen Salud e Investigación
CCBR - Buenos Aires - AR; AxisMed SRL
ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas
Centro de Investigaciones Medicas Mar Del Plata
Instituto de Investigaciones Clinicas
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
Centro Medico Privado de Reumatologia; Reumathology
CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica
CMiP - Centro Mineiro de Pesquisa*X*
Centro de Estudos em Terapias Inovadoras - CETI
CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
LMK Serviços Médicos S/S
CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
IMA Brasil - Instituto de Medicina Avancada
MHAT "Eurohospital" - Plovdiv, OOD; Internal Department
UMHAT "Kaspela", EOOD
Medizinski Zentrar-1-Sevlievo EOOD
MHAT "Hadzhi Dimitar", OOD
Medical Center Excelsior OOD
NMTH "Tsar Boris III"
DCC "Alexandrovska", EOOD; Clinic of Neurology
MC "Synexus - Sofia", EOOD
UMHAT "SofiaMed", OOD; Department of Neurology
Centro de Investigacion Medico Asistencial S.A.S
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
Riesgo de Fractura S.A.
Consultorio Medico en Fundacion el Hospitalito de morelos A.C.
Centro de Investigacion en Reumatologia
Consultorio Particular del Dr. Miguel Cortes Hernandez
Centro de Investigacion de Tratam Innovadores de Sin SC
Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis
Centro de Investigacion Clínica GRAMEL S.C
Policlinica Medica de Queretaro S.C.
Clinical Research Institute
Unidad de Enfermedades Reumaticas y Cronicodegenerativas
NZOZ ZDROWIE Osteo-Medic
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
Centrum Medyczne Pratia Katowice I
CCBR - Lodz - PL
ETYKA Osrodek Badan Kliniczynch
Ai Centrum Medyczne Sp. Z O.O Sp.K.
Medycyna Kliniczna
Centrum Medyczne AMED
KO-MED Centra Kliniczne Zamosc
SBIH of Yaroslavl region " Regional Clinical Hospital "; Therapy
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
SBIH of Moscow "City Clinical Hospital # 1 n. a. N. I. Pirogov"
SPb SBIH "Clinical Rheumatological Hospital # 25"
Sanavita LLC
LLC Medical Sanitary Unit
Center of Family Medicine LC
SBHI of Yaroslavl Region Clinical Hospital #3
SMMIH "Chelyabinsk Regional Clinical Hospital"
SAHI of Kem. "Regional Clinical Hospital for War Veterans"
OOO Family Polyclinic
Practical Medicine
Limited Liability Company "Centre of Medical Common Practice"
Ultramed
SEIHPE Saratov State Medical University n.a. V.I. Razumovskiy
NIH "Departmental Hospital on Station Smolensk of OJSC "Russian Railways"
Siberian State Medical University
SHI Ulyanovsk Reg Clinical Hospital
Territorial Clinical Hospital #2
Institute of Rheumatology
Clinical Center Kragujevac
Institute of Treatment and Rehabilitation "Niska Banja"
Special hospital for rheumatic diseases Novi Sad
General Hospital "Dr Laza K. Lazarevic" Sabac
MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
CI of Healthcare Kharkiv CCH #8 Dept of Therapy Kharkiv MA of PGE of MOHU
CI of TRC
Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
Medical Center of Revmotsentr LLC
Medical Center of Limited Liability Company Medical Clinic Blagomed
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
Lviv Regional Clinical Hospital Dept of Rehmuaatology D. Halytskyi Lviv NMU
CH of State Border Service of Ukraine (Military Base 2522); Dept of Therapy, D.Halytskyi Lviv NMU
A.Novak Transcarpathian Regional Clinical Hospital
National Pirogov Memorial Medical University
Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology
City Clinical Hospital #9 Dept of Therapy SI Zaporizhzhia MA of PGE of MoHU
CI City Hospital #1
CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA
CI City Hospital #7
CI Zaporizhzhia Regional Clinical Hospital of ZRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GDC-0853 (200mg BID) Cohort 1

GDC-0853 (200mg BID) Cohort 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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].

Secondary Outcome Measures

Percentage of Participants Achieving ACR50 Response up to Week 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]

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].

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.

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

Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR)

Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR)

Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28)

Percentage of Participants With Low Disease Activity (LDA) Based on DAS28

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)

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

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.

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.

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.

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

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.

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.

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)

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.

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.

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).

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).

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).

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.

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.

Full Information

NCT ID

NCT02983227

First Posted

November 29, 2016

Last Updated

July 9, 2020

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02983227

Brief Title

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

November 30, 2016 (Actual)

Primary Completion Date

July 17, 2019 (Actual)

Study Completion Date

July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Enrollment

496 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GDC-0853 (200mg BID) Cohort 1

Arm Type

Experimental

Arm Description

Arm Title

GDC-0853 (200mg BID) Cohort 2

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

GDC-0853

Other Intervention Name(s)

RO7010939

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Participants With Adverse Events (AEs)

Description

Time Frame

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

Title

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

Description

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving ACR50 Response up to Week 12

Description

Time Frame

Weeks 4, 8 and 12

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR)

Description

Time Frame

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

Title

Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR)

Description

Time Frame

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

Title

Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28)

Description

Time Frame

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

Title

Percentage of Participants With Low Disease Activity (LDA) Based on DAS28

Description

Time Frame

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

Title

Percentage of Participants With ACR/EULAR Remission

Description

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)

Time Frame

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

Title

Change From Baseline in Simplified Disease Activity Index (SDAI)

Description

Time Frame

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

Title

Change From Baseline in Clinical Disease Activity Index (CDAI)

Description

Time Frame

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

Title

Change From Baseline in Tender/Painful Joint Count Based on 68 Joints

Description

Time Frame

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

Title

Change From Baseline in Swollen Joint Count Based on 66 Joints

Description

Time Frame

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

Title

Change From Baseline in Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score

Description

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

Time Frame

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

Title

Change From Baseline in Patient's Global Assessment of Arthritis, Using VAS Score

Description

Time Frame

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

Title

Change From Baseline in Physician's Global Assessment of Arthritis, Using VAS Score

Description

Time Frame

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

Title

Change From Baseline in C-Reactive Protein (CRP) Levels

Description

C-reactive protein is a biological marker of inflammation and is measured in milligrams per decilitre (mg/dL)

Time Frame

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

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

Description

Time Frame

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

Title

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components

Description

Time Frame

Weeks 12, 24 and 52

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score

Description

Time Frame

Weeks 12, 24 and 52

Title

Area Under the Concentration Time Curve (AUC) of GDC-0853 at Steady State (AUC,ss)

Description

Population PK model estimated AUC of GDC-0853 at steady-state. AUC was measured in Nanograms (ng) per millilitre(mL)*hour (hr).

Time Frame

Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination

Title

Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)

Description

Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss).

Time Frame

Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination

Title

Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)

Description

Population PK model estimated plasma decay half life of GDC-0853 at steady-state.

Time Frame

Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination

Title

Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)

Description

Population PK model estimated apparent oral clearance of GDC-0853 at steady-state.

Time Frame

Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

76 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Arthritis & Rheumatology Associates, P.C.

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Medvin Clinical Research

City

Covina

State/Province

California

ZIP/Postal Code

91723

Country

United States

Facility Name

TriWest Research Associates, LLC

City

El Cajon

State/Province

California

ZIP/Postal Code

92020

Country

United States

Facility Name

Saint Jude Heritage Medical Grp

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

RASF-Clinical Research Center

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Clinical Research of West Florida

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Medication Management

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Oregon Health & Science Uni

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Metroplex Clinical Research Centre

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Baylor Research Inst.

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Accurate Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

Instituto de Investigaciones Clinicas-Mar del Plata

City

Buenos Aires

ZIP/Postal Code

B7600FZN

Country

Argentina

Facility Name

APRILLUS

City

Buenos Aires

ZIP/Postal Code

C1194AAO

Country

Argentina

Facility Name

Instituto centenario

City

Buenos Aires

ZIP/Postal Code

C1204AAD

Country

Argentina

Facility Name

Centro de Investigacion en Enfermedades Reumaticas CIER

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1055AAF

Country

Argentina

Facility Name

Expertia S.A- Mautalen Salud e Investigación

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1128AAE

Country

Argentina

Facility Name

CCBR - Buenos Aires - AR; AxisMed SRL

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1430CKE

Country

Argentina

Facility Name

ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas

City

Cordoba

ZIP/Postal Code

X5000BNB

Country

Argentina

Facility Name

Centro de Investigaciones Medicas Mar Del Plata

City

Mar del Plata

ZIP/Postal Code

B7600DHK

Country

Argentina

Facility Name

Instituto de Investigaciones Clinicas

City

Rosario

ZIP/Postal Code

S2000CVD

Country

Argentina

Facility Name

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

City

San Juan

ZIP/Postal Code

5400

Country

Argentina

Facility Name

Centro Medico Privado de Reumatologia; Reumathology

City

San Miguel

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica

City

Goiânia

State/Province

ZIP/Postal Code

74110-120

Country

Brazil

Facility Name

CMiP - Centro Mineiro de Pesquisa*X*

City

Juiz de Fora

State/Province

ZIP/Postal Code

36010-570

Country

Brazil

Facility Name

Centro de Estudos em Terapias Inovadoras - CETI

City

Curtiba

State/Province

ZIP/Postal Code

80030-110

Country

Brazil

Facility Name

CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

City

Rio de Janeiro

State/Province

ZIP/Postal Code

21941-913

Country

Brazil

Facility Name

LMK Serviços Médicos S/S

City

Porto Alegre

State/Province

ZIP/Postal Code

90480-000

Country

Brazil

Facility Name

CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

City

Campinas

State/Province

ZIP/Postal Code

13087-567

Country

Brazil

Facility Name

IMA Brasil - Instituto de Medicina Avancada

City

Sao Paulo

State/Province

ZIP/Postal Code

05437-000

Country

Brazil

Facility Name

MHAT "Eurohospital" - Plovdiv, OOD; Internal Department

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

UMHAT "Kaspela", EOOD

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Medizinski Zentrar-1-Sevlievo EOOD

City

Sevlievo

ZIP/Postal Code

5400

Country

Bulgaria

Facility Name

MHAT "Hadzhi Dimitar", OOD

City

Sliven

ZIP/Postal Code

8800

Country

Bulgaria

Facility Name

Medical Center Excelsior OOD

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

NMTH "Tsar Boris III"

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

DCC "Alexandrovska", EOOD; Clinic of Neurology

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

MC "Synexus - Sofia", EOOD

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

UMHAT "SofiaMed", OOD; Department of Neurology

City

Sofia

ZIP/Postal Code

1797

Country

Bulgaria

Facility Name

Centro de Investigacion Medico Asistencial S.A.S

City

Barranquilla

ZIP/Postal Code

80020

Country

Colombia

Facility Name

Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Riesgo de Fractura S.A.

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

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

City

Cuernavaca

State/Province

Morelos

ZIP/Postal Code

62170

Country

Mexico

Facility Name

Centro de Investigacion en Reumatologia

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Consultorio Particular del Dr. Miguel Cortes Hernandez

City

Cuernavaca

ZIP/Postal Code

62290

Country

Mexico

Facility Name

Centro de Investigacion de Tratam Innovadores de Sin SC

City

Culiacan

ZIP/Postal Code

80230

Country

Mexico

Facility Name

Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis

City

Mexicali

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Centro de Investigacion Clínica GRAMEL S.C

City

Mexico

ZIP/Postal Code

03720

Country

Mexico

Facility Name

Policlinica Medica de Queretaro S.C.

City

Queretaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

Clinical Research Institute

City

Tlalnepantla

ZIP/Postal Code

54055

Country

Mexico

Facility Name

Unidad de Enfermedades Reumaticas y Cronicodegenerativas

City

Torreon

ZIP/Postal Code

27000

Country

Mexico

Facility Name

NZOZ ZDROWIE Osteo-Medic

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Centrum Medyczne Pratia Katowice I

City

Katowice

ZIP/Postal Code

40-081

Country

Poland

Facility Name

CCBR - Lodz - PL

City

Lodz

ZIP/Postal Code

90-368

Country

Poland

Facility Name

ETYKA Osrodek Badan Kliniczynch

City

Olsztyn

ZIP/Postal Code

10-117

Country

Poland

Facility Name

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

City

Poznan

ZIP/Postal Code

61-113

Country

Poland

Facility Name

Medycyna Kliniczna

City

Warszawa

ZIP/Postal Code

00-660

Country

Poland

Facility Name

Centrum Medyczne AMED

City

Warszawa

ZIP/Postal Code

03-291

Country

Poland

Facility Name

KO-MED Centra Kliniczne Zamosc

City

Zamosc

ZIP/Postal Code

22400

Country

Poland

Facility Name

SBIH of Yaroslavl region " Regional Clinical Hospital "; Therapy

City

Yaroslavl

State/Province

Jaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

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

City

Moscow

State/Province

Moskovskaja Oblast

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

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

City

Moscow

State/Province

Moskovskaja Oblast

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

SPb SBIH "Clinical Rheumatological Hospital # 25"

City

Saint-Petersburg

State/Province

Sankt Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Sanavita LLC

City

Sankt-peterburg

State/Province

Sankt Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

LLC Medical Sanitary Unit

City

Sankt-peterburg

State/Province

Sankt Petersburg

ZIP/Postal Code

196066

Country

Russian Federation

Facility Name

Center of Family Medicine LC

City

Yekaterinburg

State/Province

Sankt Petersburg

ZIP/Postal Code

620043

Country

Russian Federation

Facility Name

SBHI of Yaroslavl Region Clinical Hospital #3

City

Yaroslavl

State/Province

Volgograd

ZIP/Postal Code

150051

Country

Russian Federation

Facility Name

SMMIH "Chelyabinsk Regional Clinical Hospital"

City

Chelyabinsk

State/Province

Voronez

ZIP/Postal Code

454076

Country

Russian Federation

Facility Name

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

City

Kemerovo

ZIP/Postal Code

650000

Country

Russian Federation

Facility Name

OOO Family Polyclinic

City

Korolev, Moscow Region

ZIP/Postal Code

141060

Country

Russian Federation

Facility Name

Practical Medicine

City

Moscow

ZIP/Postal Code

115404

Country

Russian Federation

Facility Name

Limited Liability Company "Centre of Medical Common Practice"

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Ultramed

City

Omsk

ZIP/Postal Code

644024

Country

Russian Federation

Facility Name

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

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

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

City

Smolensk

ZIP/Postal Code

214025

Country

Russian Federation

Facility Name

Siberian State Medical University

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

SHI Ulyanovsk Reg Clinical Hospital

City

Ulyanovsk

ZIP/Postal Code

432063

Country

Russian Federation

Facility Name

Territorial Clinical Hospital #2

City

Vladivostok

ZIP/Postal Code

690035

Country

Russian Federation

Facility Name

Institute of Rheumatology

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Clinical Center Kragujevac

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Institute of Treatment and Rehabilitation "Niska Banja"

City

Niska Banja

ZIP/Postal Code

18205

Country

Serbia

Facility Name

Special hospital for rheumatic diseases Novi Sad

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

General Hospital "Dr Laza K. Lazarevic" Sabac

City

Sabac

ZIP/Postal Code

15000

Country

Serbia

Facility Name

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

City

Kyiv

State/Province

Chernihiv Governorate

ZIP/Postal Code

01601

Country

Ukraine

Facility Name

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

City

Kharkiv

State/Province

Kharkiv Governorate

ZIP/Postal Code

61176

Country

Ukraine

Facility Name

CI of TRC

City

Ternopil

State/Province

Kherson Governorate

ZIP/Postal Code

46002

Country

Ukraine

Facility Name

Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU

City

Ivano-Frankivsk

State/Province

KIEV Governorate

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

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

City

Kyiv

State/Province

KIEV Governorate

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Medical Center of Revmotsentr LLC

City

Kyiv

State/Province

KIEV Governorate

ZIP/Postal Code

04070

Country

Ukraine

Facility Name

Medical Center of Limited Liability Company Medical Clinic Blagomed

City

Kyiv

State/Province

KIEV Governorate

ZIP/Postal Code

1023

Country

Ukraine

Facility Name

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

City

Kyiv

State/Province

KIEV Governorate

ZIP/Postal Code

2091

Country

Ukraine

Facility Name

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

City

Lviv

State/Province

KIEV Governorate

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

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

City

Lviv

State/Province

KIEV Governorate

ZIP/Postal Code

79014

Country

Ukraine

Facility Name

A.Novak Transcarpathian Regional Clinical Hospital

City

Uzhgorod

State/Province

KIEV Governorate

ZIP/Postal Code

88018

Country

Ukraine

Facility Name

National Pirogov Memorial Medical University

City

Vinnytsia

State/Province

Podolia Governorate

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

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

City

Dnipro

State/Province

Tavria Okruha

ZIP/Postal Code

49008

Country

Ukraine

Facility Name

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

City

Zaporizhzhia

State/Province

Tavria Okruha

ZIP/Postal Code

69065

Country

Ukraine

Facility Name

CI City Hospital #1

City

Zaporizhzhia

State/Province

Tavria Okruha

ZIP/Postal Code

69104

Country

Ukraine

Facility Name

CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis

City

Lutsk

State/Province

Volhynian Governorate

ZIP/Postal Code

43024

Country

Ukraine

Facility Name

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

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

City

Kyiv

ZIP/Postal Code

02232

Country

Ukraine

Facility Name

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

City

Poltava

ZIP/Postal Code

36011

Country

Ukraine

Facility Name

CI City Hospital #7

City

Zaporizhzhia

ZIP/Postal Code

69118

Country

Ukraine

Facility Name

CI Zaporizhzhia Regional Clinical Hospital of ZRC

City

Zaporizhzhia

ZIP/Postal Code

69600

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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