Back to results

Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GDC-0853

Adalimumab

Folic Acid

MTX

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have a diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for RA
RA disease activity by joint counts and laboratory markers of inflammation: greater than or equal to (>=) 6 tender/painful joints on motion (68 joint count) and >= 6 swollen joints (66 joint count) at both screening and Day 1 (randomization)
For MTX-inadequate response (IR) participants: must have had an inadequate response to MTX
For TNF-IR participants: must have had an inadequate response or intolerance to previous treatment with at least 1 and no more than 2 biologic TNF-alpha inhibitors and may have also been exposed to no more than one biologic non-TNF-alpha inhibitor
High sensitivity C-reactive protein of >= 0.400 milligrams per deciliter (mg/dL) for Cohort 1 and >= 0.650 mg/dL for Cohort 2 at screening

Exclusion Criteria:

History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder
For MTX-IR participants: History of treatment with any TNF inhibitor, including biosimilar equivalents and history of treatment with biologic non-TNF-alpha inhibitor for RA
For all participants: Previous treatment with cell-depleting therapy including B cell-depleting therapy (e.g., anti-cluster of differentiation 20-directed therapy such as rituximab), tofacitinib, or other Janus kinase inhibitor(s), or alkylating agents
Current treatment with medications that are well known to prolong the QT interval at doses that have a clinically meaningful effect on QT
History of non-gallstone-related pancreatitis or chronic pancreatitis
Evidence of serious uncontrolled concomitant cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease
Evidence of chronic and/or active hepatitis B or C
Women who are pregnant, nursing (breast feeding), or intending to become pregnant during the study or within 60 days after completion of the study

Sites / Locations

Pinnacle Research Group; Llc, Central
Arizona Arthritis & Rheumatology Associates, P.C.
Medvin Clinical Research
TriWest Research Associates, LLC
Saint Jude Heritage Medical Grp
Stanford University School of Medicine
RASF-Clinical Research Center
ZASA Clinical Research
Clinical Research of West Florida
InVentiv Health
Omega Research Consultants
McIlwain Medical Group
Institute of Arthritis Research
Advanced Clinical Research
Medication Management
Oregon Health and Science University
Clinical Research Center of Reading
Metroplex Clinical Research
Baylor Research Inst.
Accurate Clinical Management - VO
Accurate Clinical Research
Crossroads Clinical Research, LLC
Danville Orthopedic Clinic, Inc.; Research Department
Instituto de Investigaciones Clinicas-Mar del Plata
Organizacion Medica de Investigacion
Hospital Italiano
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
Hospital Italiano de La Plata
Centro de Investigaciones Medicas Mar Del Plata
Instituto de Investigaciones Clínicas Quilmes
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
Centro Medico Privado de Reumatologia; Reumathology
CIP - Centro Internacional de Pesquisa; Pesquisa Clinica
Centro Mineiro de Pesquisa - CMIP
Edumed - Educação e Saúde SA
Centro de Estudos em Terapias Inovadoras - CETI
CCBR - Synarc Centro de Pesquisa Clinica - RJ
Hospital Sao Vicente de Paulo
LMK Serviços Médicos S/S
CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
Faculdade de Medicina do ABC - FMABC
Instituto de Pesquisa Clínica e Medicina Avançada Ltda
Fundação Faculdade Regional de Medicina de São José do Rio Preto
CPCLIN - Centro de Pesquisas Clínicas Ltda.; Pesquisa Clinica
MHAT - Dobrich, AD
MHAT "Eurohospital" - Plovdiv, OOD
MHAT Kaspela; EOOD
MHAT - Ruse, AD
Medizinski Zentrar-1-Sevlievo EOOD
MHAT "Hadzhi Dimitar", OOD
Medical Center Excelsior OOD
NMTH "Tsar Boris III"
MHAT "Lyulin", EAD
DCC "Alexandrovska", EOOD; Clinic of Neurology
UMHAT "SofiaMed", OOD
MC "Synexus - Sofia", EOOD
MHAT Dr. St. Kirkovich, AD
'New Medical Center' , EOOD
Centro de Reumatologia y Ortopedia
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
Riesgo de Fractura S.A.
Fundación Instituto de Reumatología Fernando Chalem
Clinica de Artritis Temprana S.A.
Hospital Pablo Tobon Uribe
Chungnam National University Hospital; Department of Internal Medicine (Rheumatology)
Chonnam National University Hospital
Seoul National University Bundang Hospital
Seoul National University Hospital
Konkuk University Medical Center
Asan Medical Center - Oncology
Ajou University Hospital
Consultorio Medico en Fundacion el Hospitalito de morelos A.C.
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
Centro de Investigacion en Reumatologia
Consultorio Particular del Dr. Miguel Cortes Hernandez
Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis
Centro de Investigacion Clínica GRAMEL S.C
Policilinica Medica de Queretaro; Rheumatology
Clinical Research Institute
Unidad de Enfermedades Reumaticas y Cronicodegenerativas
NZOZ OSTEO-MEDIC S.C. Artur Racewicz, Jerzy Supronik
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
Medica Pro Familia Spolka Akcyjna Oddzial w Katowicach
Centrum Medyczne Plejady
CCBR - Lodz - PL
ETYKA Osrodek Badan Kliniczynch
Ai Centrum Medyczne Sp. Z O.O Sp.K.
KO-MED Centra Kliniczne Staszow
Medycyna Kliniczna
Centrum Medyczne AMED
Wojewódzki Szpital Specjalistyczny we Wrocławiu
KO-MED Centra Kliniczne Zamosc
TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
SBIH of Moscow "City Clinical Hospital # 1 n. a. N. I. Pirogov"
SBEI HPE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
Technologii zdorovia LLC
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
SBEI HPE "Saratov State Medical University n.a. V. I. Razumovskiy" of the MoH of the RF
SBEI HPE "Smolensk State Medical University" of the MoH of the RF
City Hospital 25; Rheumatology
Pavlov First Saint Petersburg State Medical University
Siberian State Medical University
SHI Ulyanovsk Reg Clinical Hospital
Territorial Clinical Hospital #2
SHI Yaroslavl Regional Clinical Hospital
Institute of Rheumatology
Military Medical Academy
Clinical Center Kragujevac
Institute of Treatment and Rehabilitation "Niska Banja"
Special hospital for rheumatic diseases Novi Sad
General Hospital Sabac; Department of Urology and Hemodialysis
CI of TRC
Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
Medical Center Medical Clinic Blagomed LLC.
Medical Center OK!Clinic+
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
Clinic of Modern Rheumatology Revmotsentr LLC
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
Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv MA of PGE of MOHU Ch of Cardiology and Functional Diagnostics
CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
MI of Helathcare Kyiv RCH P.L. Shupy NMA of PGE
Gerontology Institute of the Ukrainian AMS
Oleksandrivska Clinical Hospital
Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
City Hospital #1
M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA
Private Small Enterprise Medical Center Pulse
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
City Clinical Hospital #9 Dept of Gastrosurgery SI Zaporizhzhia MA of PGE of MoHU
CI City Hospital #7
CI Zaporizhzhia Regional Clinical Hospital of ZRC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Cohort 1: GDC-0853 High Dose + Adalimumab Placebo

Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo

Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo

Cohort 1: GDC-0853 Placebo + Adalimumab

Cohort 1: GDC-0853 Placebo + Adalimumab Placebo

Cohort 2: GDC-0853 High Dose

Cohort 2: GDC-0853 Placebo

Arm Description

Participants of Cohort 1 will receive GDC-0853 high dose, orally once daily along with placebo matched to adalimumab, subcutaneously every 2 weeks (Q2W) starting on Day 1 for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 milligrams per week (mg/week) (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.

Participants of Cohort 1 will receive GDC-0853 low dose, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.

Participants of Cohort 1 will receive GDC-0853 mid dose, orally twice daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.

Participants of Cohort 1 will receive placebo matched to GDC-0853, orally once daily along with adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.

Participants of Cohort 1 will receive placebo matched to GDC-0853, orally once daily along with placebo matched to adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.

Participants of Cohort 2 will receive GDC-0853 high dose, orally twice daily for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.

Participants of Cohort 2 will receive placebo matched to GDC-0853, orally twice daily for 12 weeks. Participants will remain on a stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines) and folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1)

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].

Percentage of Participants With Adverse Events

An Adverse event 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. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.

Secondary Outcome Measures

Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1)

Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 2)

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 50% (ACR50) Response

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].

Change in Disease Activity Score From Baseline 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.

Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])

Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])

Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

Percentage of Participants With DAS Low Disease Activity

Percentage of Participants With DAS Remission

Percentage of Participants Meeting the Boolean-based Remission Criteria

Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale).

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.

Percentage of Participants Meeting the CDAI-based Remission Criteria

Clinical Disease Activity Index is defined as CDAI= : SJC(28) + TJC(28) + PGA + MDG where TJC and SJC are the tender and swollen joint counts from 28 joints, PGA is the patient's global assessment of disease activity (on a 0-10 scale) and MDG is physician global assessment of disease activity (on a 0-10 scale). The cutoff value for CDAI remission is <=2.8.

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

Percentage of Participants Meeting the SDAI-based Remission Criteria

The SDAI was the numerical sum of five outcome parameter: SJC and TJC (based on a 28-joint assessment), PGA and MDG (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. The SDAI =< 3.3 indicates disease remission

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).

Change From Baseline in Tender/Painful Joint Count (68 Joint Count)

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 (66 Joint Count)

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 Assessment Score of Arthritis Pain

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 Global Assessment Score of Arthritis Pain

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 Score of Arthritis

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 nanograms per milliliter (ng/mL)

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.

Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss)

The Pharmacokinetics (PK) evaluation may include, but will not be limited to, plasma GDC-0853 concentrations and population PK model estimated PK exposures (area under the plasma concentration-time curve [AUC]. AUC was measured in Nanograms(ng) per millilitre(mL)*hour (hr)

Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss)

Cmax is the maximum (peak) plasma concentration over the dosing interval at steady state (ss)

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

Cmin is the minimum concentration over the dosing interval at steady state (ss)

Full Information

NCT ID

NCT02833350

First Posted

July 12, 2016

Last Updated

June 1, 2020

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02833350

Brief Title

Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)

Official Title

A Two-Cohort Randomized Phase II, Double-Blind, Parallel Group Study in Patients With Active Rheumatoid Arthritis Evaluating the Efficacy and Safety of GDC-0853 Compared With Placebo and Adalimumab in Patients With an Inadequate Response to Previous Methotrexate Therapy (Cohort 1) and Compared With Placebo in Patients With an Inadequate Response or Intolerance to Previous TNF Therapy (Cohort 2)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

September 9, 2016 (Actual)

Primary Completion Date

July 2, 2018 (Actual)

Study Completion Date

July 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary

This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and safety of GDC-0853 in participants with moderate to severe active RA and an inadequate response to previous methotrexate (MTX) therapy (Cohort 1) or MTX and tumor necrosis factor (TNF) therapy who may have also had exposure to no more than one non-TNF inhibitor biologic (Cohort 2).

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

ParticipantInvestigator

Allocation

Randomized

Enrollment

578 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: GDC-0853 High Dose + Adalimumab Placebo

Arm Type

Experimental

Arm Description

Arm Title

Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo

Arm Type

Experimental

Arm Description

Arm Title

Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo

Arm Type

Experimental

Arm Description

Arm Title

Cohort 1: GDC-0853 Placebo + Adalimumab

Arm Type

Active Comparator

Arm Description

Arm Title

Cohort 1: GDC-0853 Placebo + Adalimumab Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Cohort 2: GDC-0853 High Dose

Arm Type

Experimental

Arm Description

Arm Title

Cohort 2: GDC-0853 Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

GDC-0853

Other Intervention Name(s)

RO7010939

Intervention Description

Participants will receive GDC-0853 at low, mid, or high doses, orally once or twice daily for 12 weeks in Cohort 1 or 2.

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Intervention Description

Participants will receive adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Folic Acid

Intervention Description

Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.

Intervention Type

Drug

Intervention Name(s)

MTX

Intervention Description

Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive placebo matched to adalimumab, subcutaneously Q2W and/or placebo matched to GDC-0853, orally once or twice daily for 12 weeks in Cohort 1 or 2.

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1)

Description

Time Frame

Day 84

Title

Percentage of Participants With Adverse Events

Description

Time Frame

Day 1 up to 8 weeks after last dose (up to Week 20)

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1)

Description

Time Frame

Day 84

Title

Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 2)

Description

Time Frame

Day 84

Title

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

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

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

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

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

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

Percentage of Participants With DAS Low Disease Activity

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

Percentage of Participants With DAS Remission

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

Percentage of Participants Meeting the Boolean-based Remission Criteria

Description

Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale).

Time Frame

Days 7, 14, 28, 56, and 84

Title

Change From Baseline in Clinical Disease Activity Index (CDAI)

Description

Time Frame

Baseline, Days 7, 14, 28, 56 and 84

Title

Percentage of Participants Meeting the CDAI-based Remission Criteria

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

Change From Baseline in Simplified Disease Activity Index (SDAI)

Description

Time Frame

Baseline, Days 7, 14, 28, 56 and 84

Title

Percentage of Participants Meeting the SDAI-based Remission Criteria

Description

Time Frame

Days 7, 14, 28, 56, and 84

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

Day 84

Title

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

Description

Time Frame

Day 84

Title

Change From Baseline in Tender/Painful Joint Count (68 Joint Count)

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

Change From Baseline in Swollen Joint Count (66 Joint Count)

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

Change From Baseline in Patient Assessment Score of Arthritis Pain

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

Days 7, 14, 28, 56, and 84

Title

Change From Baseline in Patient Global Assessment Score of Arthritis Pain

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

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

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

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

Description

C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL)

Time Frame

Days 7, 14, 28, 56, and 84

Title

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

Description

Time Frame

Days 7, 14, 28, 56, and 84

Title

Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss)

Description

Time Frame

Pre-dose (0 hours) up to 10 hours post-dose on Day 28

Title

Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss)

Description

Cmax is the maximum (peak) plasma concentration over the dosing interval at steady state (ss)

Time Frame

Pre-dose (0 hours) up to 10 hours post-dose on Day 28

Title

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

Description

Cmin is the minimum concentration over the dosing interval at steady state (ss)

Time Frame

Pre-dose (0 hours) up to 10 hours post-dose on Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for RA RA disease activity by joint counts and laboratory markers of inflammation: greater than or equal to (>=) 6 tender/painful joints on motion (68 joint count) and >= 6 swollen joints (66 joint count) at both screening and Day 1 (randomization) For MTX-inadequate response (IR) participants: must have had an inadequate response to MTX For TNF-IR participants: must have had an inadequate response or intolerance to previous treatment with at least 1 and no more than 2 biologic TNF-alpha inhibitors and may have also been exposed to no more than one biologic non-TNF-alpha inhibitor High sensitivity C-reactive protein of >= 0.400 milligrams per deciliter (mg/dL) for Cohort 1 and >= 0.650 mg/dL for Cohort 2 at screening Exclusion Criteria: History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder For MTX-IR participants: History of treatment with any TNF inhibitor, including biosimilar equivalents and history of treatment with biologic non-TNF-alpha inhibitor for RA For all participants: Previous treatment with cell-depleting therapy including B cell-depleting therapy (e.g., anti-cluster of differentiation 20-directed therapy such as rituximab), tofacitinib, or other Janus kinase inhibitor(s), or alkylating agents Current treatment with medications that are well known to prolong the QT interval at doses that have a clinically meaningful effect on QT History of non-gallstone-related pancreatitis or chronic pancreatitis Evidence of serious uncontrolled concomitant cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease Evidence of chronic and/or active hepatitis B or C Women who are pregnant, nursing (breast feeding), or intending to become pregnant during the study or within 60 days after completion of the study

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

Pinnacle Research Group; Llc, Central

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

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

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305-5151

Country

United States

Facility Name

RASF-Clinical Research Center

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

ZASA Clinical Research

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33472

Country

United States

Facility Name

Clinical Research of West Florida

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

InVentiv Health

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Omega Research Consultants

City

Orlando

State/Province

Florida

ZIP/Postal Code

32810

Country

United States

Facility Name

McIlwain Medical Group

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Institute of Arthritis Research

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Advanced Clinical Research

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Medication Management

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Clinical Research Center of Reading

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Metroplex Clinical Research

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 Management - VO

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Accurate Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

Crossroads Clinical Research, LLC

City

Victoria

State/Province

Texas

ZIP/Postal Code

77901

Country

United States

Facility Name

Danville Orthopedic Clinic, Inc.; Research Department

City

Danville

State/Province

Virginia

ZIP/Postal Code

24541

Country

United States

Facility Name

Instituto de Investigaciones Clinicas-Mar del Plata

City

Buenos Aires

ZIP/Postal Code

B7600FZN

Country

Argentina

Facility Name

Organizacion Medica de Investigacion

City

Buenos Aires

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

Hospital Italiano

City

Buenos Aires

ZIP/Postal Code

C1181ACH

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

Hospital Italiano de La Plata

City

La Plata

ZIP/Postal Code

1900

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 Clínicas Quilmes

City

Quilmes

ZIP/Postal Code

1878

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; Pesquisa Clinica

City

Goiânia

State/Province

ZIP/Postal Code

74110-120

Country

Brazil

Facility Name

Centro Mineiro de Pesquisa - CMIP

City

Juiz de Fora

State/Province

ZIP/Postal Code

36036-330

Country

Brazil

Facility Name

Edumed - Educação e Saúde SA

City

Curitiba

State/Province

ZIP/Postal Code

80440-080

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 - Synarc Centro de Pesquisa Clinica - RJ

City

Rio de Janeiro

State/Province

ZIP/Postal Code

22271-100

Country

Brazil

Facility Name

Hospital Sao Vicente de Paulo

City

Passo Fundo

State/Province

ZIP/Postal Code

99010-090

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

Faculdade de Medicina do ABC - FMABC

City

Santo Andre

State/Province

ZIP/Postal Code

09060-650

Country

Brazil

Facility Name

Instituto de Pesquisa Clínica e Medicina Avançada Ltda

City

Sao Paulo

State/Province

ZIP/Postal Code

05437-010

Country

Brazil

Facility Name

Fundação Faculdade Regional de Medicina de São José do Rio Preto

City

São José do Rio Preto

State/Province

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

CPCLIN - Centro de Pesquisas Clínicas Ltda.; Pesquisa Clinica

City

São Paulo

State/Province

ZIP/Postal Code

01244-030

Country

Brazil

Facility Name

MHAT - Dobrich, AD

City

Dobrich

ZIP/Postal Code

9300

Country

Bulgaria

Facility Name

MHAT "Eurohospital" - Plovdiv, OOD

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

MHAT Kaspela; EOOD

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

MHAT - Ruse, AD

City

Ruse

ZIP/Postal Code

7002

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

MHAT "Lyulin", EAD

City

Sofia

ZIP/Postal Code

1336

Country

Bulgaria

Facility Name

DCC "Alexandrovska", EOOD; Clinic of Neurology

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

UMHAT "SofiaMed", OOD

City

Sofia

ZIP/Postal Code

1750

Country

Bulgaria

Facility Name

MC "Synexus - Sofia", EOOD

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

MHAT Dr. St. Kirkovich, AD

City

Stara Zagora

ZIP/Postal Code

6003

Country

Bulgaria

Facility Name

'New Medical Center' , EOOD

City

Vratsa

ZIP/Postal Code

3000

Country

Bulgaria

Facility Name

Centro de Reumatologia y Ortopedia

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

Fundación Instituto de Reumatología Fernando Chalem

City

Bogota

ZIP/Postal Code

111211

Country

Colombia

Facility Name

Clinica de Artritis Temprana S.A.

City

Cali

ZIP/Postal Code

00000

Country

Colombia

Facility Name

Hospital Pablo Tobon Uribe

City

Medellin

ZIP/Postal Code

050034

Country

Colombia

Facility Name

Chungnam National University Hospital; Department of Internal Medicine (Rheumatology)

City

Daejeon

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

Chonnam National University Hospital

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital

City

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Konkuk University Medical Center

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

Asan Medical Center - Oncology

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Ajou University Hospital

City

Suwon City

ZIP/Postal Code

443-721

Country

Korea, Republic of

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 Investigación de Tratamientos Innovadores de Sinaloa (CITI)

City

Culiacán Rosales

State/Province

Sinaloa

ZIP/Postal Code

80000

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 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

Policilinica Medica de Queretaro; Rheumatology

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 OSTEO-MEDIC S.C. Artur Racewicz, Jerzy Supronik

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

Medica Pro Familia Spolka Akcyjna Oddzial w Katowicach

City

Katowice

ZIP/Postal Code

40-081

Country

Poland

Facility Name

Centrum Medyczne Plejady

City

Krakow

ZIP/Postal Code

30-349

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

KO-MED Centra Kliniczne Staszow

City

Staszow

ZIP/Postal Code

28-200

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

Wojewódzki Szpital Specjalistyczny we Wrocławiu

City

Wrocław

ZIP/Postal Code

51-124

Country

Poland

Facility Name

KO-MED Centra Kliniczne Zamosc

City

Zamosc

ZIP/Postal Code

22400

Country

Poland

Facility Name

TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich

City

Krasnoyarsk

State/Province

Krasnojarsk

ZIP/Postal Code

660062

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

SBEI HPE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF

City

Moscow

State/Province

Moskovskaja Oblast

ZIP/Postal Code

119992

Country

Russian Federation

Facility Name

Technologii zdorovia LLC

City

Sankt-peterburg

State/Province

Sankt Petersburg

ZIP/Postal Code

191144

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

SBEI HPE "Saratov State Medical University n.a. V. I. Razumovskiy" of the MoH of the RF

City

Saratov

ZIP/Postal Code

410026

Country

Russian Federation

Facility Name

SBEI HPE "Smolensk State Medical University" of the MoH of the RF

City

Smolensk

ZIP/Postal Code

214019

Country

Russian Federation

Facility Name

City Hospital 25; Rheumatology

City

St. Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Pavlov First Saint Petersburg State Medical University

City

St. Petersburg

ZIP/Postal Code

197022

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

SHI Yaroslavl Regional Clinical Hospital

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Institute of Rheumatology

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Military Medical Academy

City

Belgrade

ZIP/Postal Code

11040

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 Sabac; Department of Urology and Hemodialysis

City

Sabac

ZIP/Postal Code

15000

Country

Serbia

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

Medical Center Medical Clinic Blagomed LLC.

City

Kyiv

State/Province

KIEV Governorate

ZIP/Postal Code

01601

Country

Ukraine

Facility Name

Medical Center OK!Clinic+

City

Kyiv

State/Province

KIEV Governorate

ZIP/Postal Code

02091

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

Clinic of Modern Rheumatology Revmotsentr LLC

City

Kyiv

State/Province

KIEV Governorate

ZIP/Postal Code

04071

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

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

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

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Kharkiv MA of PGE of MOHU Ch of Cardiology and Functional Diagnostics

City

Kharkiv

ZIP/Postal Code

61176

Country

Ukraine

Facility Name

CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

City

Kyiv

ZIP/Postal Code

02232

Country

Ukraine

Facility Name

MI of Helathcare Kyiv RCH P.L. Shupy NMA of PGE

City

Kyiv

ZIP/Postal Code

04107

Country

Ukraine

Facility Name

Gerontology Institute of the Ukrainian AMS

City

Kyiv

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

Oleksandrivska Clinical Hospital

City

Kyiv

ZIP/Postal Code

1023

Country

Ukraine

Facility Name

Volyn Regional Center of Cardiovascular Pathology and Thrombolysis

City

Lutsk

ZIP/Postal Code

43024

Country

Ukraine

Facility Name

City Hospital #1

City

Mykolaiv

ZIP/Postal Code

54003

Country

Ukraine

Facility Name

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

City

Poltava

ZIP/Postal Code

36011

Country

Ukraine

Facility Name

Private Small Enterprise Medical Center Pulse

City

Vinnytsia

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

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

City

Zaporizhzhia

ZIP/Postal Code

69096

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

Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)

We'll reach out to this number within 24 hrs