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Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA) (CHS-0214-02)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etanercept
CHS-0214
Sponsored by
Coherus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring CHS-0214, Enbrel, RA, Biosimilar, Etanercept

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female adults
  • RA (Rheumatoid Arthritis) diagnosis for 6 months
  • On stable dose of MTX of 8mg to 25mg per week
  • Active disease: greater than 6 tender joints, greater than 6 swollen joints, C-reactive protein (CRP) greater than or equal to 0.5mg/dL, and disease activity score (DAS) with 28 joints (DAS28-CRP(4)) greater than or equal to 3.2

Exclusion Criteria:

  • Use of prednisone greater than 10mg/day
  • Use of greater than one non-steroidal anti-inflammatory drug (NSAID)
  • Use of biologic therapies for any cause
  • Chemistry and hematology values outside protocol specified range
  • Positive QuantiFERON-tuberculosis (TB) Gold Test
  • Evidence of active lung disease on chest x-ray
  • Major systemic infections
  • Presence of significant comorbid conditions
  • Known allergy to latex
  • Women who are pregnant or nursing

Sites / Locations

  • Elite Clinical Studies
  • Arizona Research Center
  • NEA Baptist Clinic
  • Dream Team Clinical Research
  • Advanced Medical Research
  • Pro Health Partners
  • St. Joseph Hospital of Orange
  • Desert Medical Advances
  • Kaiser Permanente - CA
  • Med Investigators, Inc
  • Troum Medical Associates
  • Inland Rheumatology Clinical Trials Inc
  • IMMUNOe International Research Centers
  • Hope Clinical Research
  • Advanced Medical Research, Inc
  • Allergy & Rheumatology Associates LLC
  • HealthPoint Medical Group
  • Bluegrass Community Research, Inc
  • The Center for Rheumatology and Bone Research
  • Clinical Pharmacology Study Group
  • St. Louis Center for Clinical Research
  • Arthritis Center of Nebraska
  • Pacific Arthritis Center Medical Group
  • Rheumatoid Arthritis Investigational Network
  • Montefiore Medical Center
  • North Shore University Hospital
  • DJL Clinical Research
  • PMG Research of Wilmington LLC
  • Altoona Center for Clinical Research
  • Low Country Rheumatology
  • Arthritis Clinic
  • Texas Physicians Medical Research Group
  • Metroplex Clinical Research Center
  • Pioneer Research Solutions Inc
  • Arthritis Northwest Rheumatology PLLC
  • Rheumatic Disease Center
  • Gundersen Lutheran Medical Center
  • Brest Regional Clinical Hospital
  • Gomel Regional Clinical Hospital
  • Grodno Regional Clinical Hospital
  • City Clinical Hospital #1 - Belarus
  • City Clinical Hospital #9 - Belarus
  • Vitebsk Regional Clinical Hospital
  • Hôpital Michallon - CHU de Grenobl
  • CHU Bicetre
  • Centre Hospitalier Regional D'Orleans
  • Hopital Cochin-Saint Vincent de Paul
  • Hopital de Saint Etienne
  • Asklepios Klinikum Bad Abbach
  • Klinische Forschung Dresden GmbH
  • Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
  • Universitätsmedizin Göttingen
  • SMO.MD GmbH - Zentrum fuer klinische Studien
  • St. Rokus Hospital, BAJA
  • DRC Gyogzszervizsgalo Kozpont
  • Orszagos Reumatologiai es Fizioterapias Intezet
  • Qualiclinic Kft
  • Békés Megyei Pándy Kálmán Kórház
  • University of Szeged, Faculty of Medicine
  • Rakoczi Ferenc Korhaz-CRU Hungary (KFT)
  • Rambam Medical Center
  • Tel Aviv Sourasky Medical Center
  • Sheba Medical Center
  • Assaf Harofeh Medical Center
  • Nagoya University Hospital
  • Inoue Hospital
  • Hiroshima Clinic
  • Izumi Himawari Clinica
  • Miyashita Rheumatology Clinic
  • Japanese Red Cross Okayama Hospital
  • Japanese Red Cross Nagoya Daiichi Hospital
  • Yamada Rheumatology Clinic
  • Shono Rheumatism Clinic
  • University of Occupational and Environmental Health Hospital
  • Kondo Clinic for Rheumatism and Orthopaedics
  • Medical Co. LTA PS Clinic
  • St Mary;s Hospital
  • Hiroshima Rheumatology Clinic
  • Medical Corporation Nakayama Clinic
  • Matsubara Mayflower Hospital
  • Yoshida Orthopaedic and Rheumatology Clinic
  • Eiraku Clinic
  • Izumihara Rheumatic and Medical Clinic
  • Kawasaki Rheumatism and Internal Medicine Clinic
  • Kumamoto Orthopaedic Hospital
  • Munakata Yasuhiko Clinic
  • Yu-Family Clinic
  • Sendai Taihaku Hospital
  • Kai Clinic
  • Zenjinkai Shimin no Mori Hospital
  • Komagamine Orthopaedic Rheumatic Clinic
  • Nagasaki Medical Hospital of Rheumatology
  • Nagasaki University Hospital
  • SaSebo Chuo Hospital
  • Oribe Clinic of Rheumatism and Medicine
  • Otsuka Clinica of Rheumatism and Medicine
  • Rinku Hashimoto Rheumatology Orthopedics
  • Koshigaya Municipal Hospital
  • Medical Corporation Kojyokai Hirose Clinic
  • Hokkaido Medical Center for Rheumatic Diseases
  • St. Luke's International Hospital
  • Keio University Hospital
  • Miyasato Clinic
  • Tokito Clinic Rheumatology and Orthopaedics, Surgery
  • Centrum Kliniczno Badawcze
  • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Mazowieckie Centrum Badan Klinicznych (MCBK) SC
  • Synexus Polska Sp. z o.o. Oddzial w Katowicach
  • Centrum Terapii Wspólczesne
  • NZOZ Lecznica MAK-MED
  • Profmedicus sp. z o.o
  • Centrum Medyczne SYNEXUS Poznan
  • Prywatna Praktyka Lekarska Prof UM dr hab. Med. Pawel Hrycaj
  • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • Centrum Medyczne AMED
  • Biogenes NZOZ
  • Synexus Polska Sp. z o.o
  • Sverdlovsk Regional Clinical Hospital #1
  • Krasnoyarsk Medical Academy
  • State Healthcare Institution of Moscow City Clinical Hospital #15 n.a. O.M. Filatov
  • Practicheskaya Meditsina, Ltd
  • Republican Hospital n.a. V.A. Baranov
  • Smolensk State Medical University (SSMU)
  • St. Petersburg State Healthcare Institution "Consultative diagnostic center #85
  • Medical Research Institute, LLC
  • Municipal Healthcare Institution "Emergency Clinical Hospital n.a. N.V. Soloviev
  • MBI "Central City Clinical Hospital #6
  • Dr CI Louw
  • Dr S Nayiager
  • Wits Donald Gordon Clinical Trial Site
  • Drs Dindar and Partners
  • Private Practice - Cathy Spargo
  • Jakaranda Hospital Pretoria
  • Emmed Research
  • Winelands Rheumatology Centre
  • Hospital Universitario Ramon y Cajal
  • Hospital La Paz
  • Hospital Regional Universitario de Málaga
  • Royal Sussex County Hospital
  • Harrogate District NHS Foundation Trust
  • Wirral University Teaching Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enbrel (etanercept)

CHS-0214

Arm Description

Enbrel 50mg weekly times 24 weeks.

CHS-0214 50mg weekly times 24 weeks.

Outcomes

Primary Outcome Measures

ACR-20 - 20% Improvement According to American College of Rheumatology Criteria
The primary efficacy endpoint in Part 1 was the percentage of subjects who achieved ACR20 (20% improvement according to American College of Rheumatology criteria) at week 24 compared to baseline (last non-missing value prior to first dose). Subjects were considered an ACR20 responder if when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC (Swollen joint count), 20% decrease in TJC (Tender joint count), and 20% improvement in 3 of the following 5 measures: high sensitivity C reactive protein(hs-CRP), Health Assessment Questionnaire Disability Index(HAQ-DI), subjects global assessment of pain(SPA, VAS), subject's global assessment of disease activity(SGA-VAS), physician's global assessment of disease activity(PGA-VAS)

Secondary Outcome Measures

ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18
Subjects were considered an ACR20 responder if, when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC, 20% decrease in TJC, and 20% improvement in 3 of the following 5 measures: High sensitivity C-reactive protein (hs-CRP); Health Assessment Questionnaire-Disability Index (HAQ-DI); Subject's global assessment of pain (ie, subject's pain assessment [SPA]-visual analog scale [VAS]); Subject's global assessment of disease activity (SGA-VAS); and Physician's global assessment of disease activity (PGA-VAS). In these calculations, the percent change from baseline to endpoint was used to determine ACR20. For percentage change calculations, results were rounded to 5 decimal places prior to comparing to the threshold of 20%.For SJCs and TJCs, the assessment of efficacy was based on mean change from baseline (last non-missing value prior to first dose evaluation).
Summary of Change in Tender Joint Count (TJC) by Study Visit
The average percent improvement from baseline in individual ACR response criteria: TJC (Tender joint count) the 66/68 Joint Count evaluates 68 joints for tenderness and pain with movement. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count. Hip joints can be evaluated for tenderness.
Summary of Change in Swollen Joint Count (SJC) by Study Visit
The 66/68 Joint Count evaluates 66 joints for swelling. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count.
Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
HAQ-DI - Scales for each question range from 0-3 (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=Unable to do). The "total" for each category is determined by the highest score (greatest difficulty) for that category. The score for the disability index is the mean of the eight category scores. If more than 2 of the categories or 25% are missing, the scale won't be scored. If fewer than 2 or the categories are missing, the sum of the categories was divided by the number of answered categories.
Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
The score range for the SPA-VAS is 0-100 millimeters. One total score was reported for each assessment, no subscales exist. A lower score on the left side represents a better outcome (less pain) and the higher score is on the right side representing a worse outcome (more pain).
Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
The score range for PGA-VAS is 0-100 millimeters. The patient's assessment of disease activity - with the lowest score on the left side representing "none" to the highest score on the right side representing "extremely active".

Full Information

First Posted
April 14, 2014
Last Updated
June 7, 2019
Sponsor
Coherus Biosciences, Inc.
Collaborators
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02115750
Brief Title
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
Acronym
CHS-0214-02
Official Title
A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coherus Biosciences, Inc.
Collaborators
Daiichi Sankyo Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies. Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety. Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
CHS-0214, Enbrel, RA, Biosimilar, Etanercept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
647 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enbrel (etanercept)
Arm Type
Active Comparator
Arm Description
Enbrel 50mg weekly times 24 weeks.
Arm Title
CHS-0214
Arm Type
Experimental
Arm Description
CHS-0214 50mg weekly times 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Etanercept
Other Intervention Name(s)
Enbrel, European Enbrel
Intervention Description
Head-to-head comparison
Intervention Type
Drug
Intervention Name(s)
CHS-0214
Primary Outcome Measure Information:
Title
ACR-20 - 20% Improvement According to American College of Rheumatology Criteria
Description
The primary efficacy endpoint in Part 1 was the percentage of subjects who achieved ACR20 (20% improvement according to American College of Rheumatology criteria) at week 24 compared to baseline (last non-missing value prior to first dose). Subjects were considered an ACR20 responder if when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC (Swollen joint count), 20% decrease in TJC (Tender joint count), and 20% improvement in 3 of the following 5 measures: high sensitivity C reactive protein(hs-CRP), Health Assessment Questionnaire Disability Index(HAQ-DI), subjects global assessment of pain(SPA, VAS), subject's global assessment of disease activity(SGA-VAS), physician's global assessment of disease activity(PGA-VAS)
Time Frame
24-weeks
Secondary Outcome Measure Information:
Title
ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18
Description
Subjects were considered an ACR20 responder if, when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC, 20% decrease in TJC, and 20% improvement in 3 of the following 5 measures: High sensitivity C-reactive protein (hs-CRP); Health Assessment Questionnaire-Disability Index (HAQ-DI); Subject's global assessment of pain (ie, subject's pain assessment [SPA]-visual analog scale [VAS]); Subject's global assessment of disease activity (SGA-VAS); and Physician's global assessment of disease activity (PGA-VAS). In these calculations, the percent change from baseline to endpoint was used to determine ACR20. For percentage change calculations, results were rounded to 5 decimal places prior to comparing to the threshold of 20%.For SJCs and TJCs, the assessment of efficacy was based on mean change from baseline (last non-missing value prior to first dose evaluation).
Time Frame
Weeks 4, 8, 12 and 18
Title
Summary of Change in Tender Joint Count (TJC) by Study Visit
Description
The average percent improvement from baseline in individual ACR response criteria: TJC (Tender joint count) the 66/68 Joint Count evaluates 68 joints for tenderness and pain with movement. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count. Hip joints can be evaluated for tenderness.
Time Frame
Weeks 4,8,12,18,24,28,36,48
Title
Summary of Change in Swollen Joint Count (SJC) by Study Visit
Description
The 66/68 Joint Count evaluates 66 joints for swelling. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count.
Time Frame
Weeks 4,8,12,18,24,28,36,48
Title
Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
Description
HAQ-DI - Scales for each question range from 0-3 (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=Unable to do). The "total" for each category is determined by the highest score (greatest difficulty) for that category. The score for the disability index is the mean of the eight category scores. If more than 2 of the categories or 25% are missing, the scale won't be scored. If fewer than 2 or the categories are missing, the sum of the categories was divided by the number of answered categories.
Time Frame
Weeks 4,8,12,18,24,28,36,48
Title
Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
Description
The score range for the SPA-VAS is 0-100 millimeters. One total score was reported for each assessment, no subscales exist. A lower score on the left side represents a better outcome (less pain) and the higher score is on the right side representing a worse outcome (more pain).
Time Frame
Weeks 4,8,12,18,24,28,36,48
Title
Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
Description
The score range for PGA-VAS is 0-100 millimeters. The patient's assessment of disease activity - with the lowest score on the left side representing "none" to the highest score on the right side representing "extremely active".
Time Frame
Weeks 4,8,12,18,24,28,36,48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adults RA (Rheumatoid Arthritis) diagnosis for 6 months On stable dose of MTX of 8mg to 25mg per week Active disease: greater than 6 tender joints, greater than 6 swollen joints, C-reactive protein (CRP) greater than or equal to 0.5mg/dL, and disease activity score (DAS) with 28 joints (DAS28-CRP(4)) greater than or equal to 3.2 Exclusion Criteria: Use of prednisone greater than 10mg/day Use of greater than one non-steroidal anti-inflammatory drug (NSAID) Use of biologic therapies for any cause Chemistry and hematology values outside protocol specified range Positive QuantiFERON-tuberculosis (TB) Gold Test Evidence of active lung disease on chest x-ray Major systemic infections Presence of significant comorbid conditions Known allergy to latex Women who are pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara K Finck, M.D.
Organizational Affiliation
Coherus Biosciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Dream Team Clinical Research
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Advanced Medical Research
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Pro Health Partners
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
St. Joseph Hospital of Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Kaiser Permanente - CA
City
Richmond
State/Province
California
ZIP/Postal Code
94801
Country
United States
Facility Name
Med Investigators, Inc
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Troum Medical Associates
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Inland Rheumatology Clinical Trials Inc
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
IMMUNOe International Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Hope Clinical Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Advanced Medical Research, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Allergy & Rheumatology Associates LLC
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
Facility Name
HealthPoint Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Bluegrass Community Research, Inc
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Arthritis Center of Nebraska
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Pacific Arthritis Center Medical Group
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Rheumatoid Arthritis Investigational Network
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
North Shore University Hospital
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
DJL Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
PMG Research of Wilmington LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Low Country Rheumatology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Arthritis Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Texas Physicians Medical Research Group
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pioneer Research Solutions Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Arthritis Northwest Rheumatology PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Rheumatic Disease Center
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Gundersen Lutheran Medical Center
City
Onalaska
State/Province
Wisconsin
ZIP/Postal Code
54650
Country
United States
Facility Name
Brest Regional Clinical Hospital
City
Brest
ZIP/Postal Code
224027
Country
Belarus
Facility Name
Gomel Regional Clinical Hospital
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
Grodno Regional Clinical Hospital
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
City Clinical Hospital #1 - Belarus
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
City Clinical Hospital #9 - Belarus
City
Minsk
ZIP/Postal Code
220116
Country
Belarus
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
Hôpital Michallon - CHU de Grenobl
City
Grenoble
ZIP/Postal Code
38434
Country
France
Facility Name
CHU Bicetre
City
Le Kremlin-Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Centre Hospitalier Regional D'Orleans
City
Orleans Cedex
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital Cochin-Saint Vincent de Paul
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital de Saint Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Asklepios Klinikum Bad Abbach
City
Bad Abbach
ZIP/Postal Code
93077
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
ZIP/Postal Code
01069
Country
Germany
Facility Name
Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
SMO.MD GmbH - Zentrum fuer klinische Studien
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
St. Rokus Hospital, BAJA
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
DRC Gyogzszervizsgalo Kozpont
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Orszagos Reumatologiai es Fizioterapias Intezet
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Qualiclinic Kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Békés Megyei Pándy Kálmán Kórház
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
University of Szeged, Faculty of Medicine
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Rakoczi Ferenc Korhaz-CRU Hungary (KFT)
City
Szikszo
ZIP/Postal Code
3800
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Nagoya University Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Inoue Hospital
City
Takasaki-shi
State/Province
Gunma
ZIP/Postal Code
370-0053
Country
Japan
Facility Name
Hiroshima Clinic
City
Nishi-ku
State/Province
Hiroshimashi
ZIP/Postal Code
733-0032
Country
Japan
Facility Name
Izumi Himawari Clinica
City
Sendai-City
State/Province
Miyagi
ZIP/Postal Code
981-3135
Country
Japan
Facility Name
Miyashita Rheumatology Clinic
City
Omura-shi
State/Province
Nagasaki
ZIP/Postal Code
856-0836
Country
Japan
Facility Name
Japanese Red Cross Okayama Hospital
City
Okayama-Shi
State/Province
Okayama
ZIP/Postal Code
700-8607
Country
Japan
Facility Name
Japanese Red Cross Nagoya Daiichi Hospital
City
Aichi
ZIP/Postal Code
453-8511
Country
Japan
Facility Name
Yamada Rheumatology Clinic
City
Ehime
ZIP/Postal Code
790-0905
Country
Japan
Facility Name
Shono Rheumatism Clinic
City
Fukuoka-shi
ZIP/Postal Code
814-002
Country
Japan
Facility Name
University of Occupational and Environmental Health Hospital
City
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Kondo Clinic for Rheumatism and Orthopaedics
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
Medical Co. LTA PS Clinic
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
St Mary;s Hospital
City
Fukuoka
ZIP/Postal Code
830-8543
Country
Japan
Facility Name
Hiroshima Rheumatology Clinic
City
Hiroshima
ZIP/Postal Code
730-0017
Country
Japan
Facility Name
Medical Corporation Nakayama Clinic
City
Hyogo
ZIP/Postal Code
650-0044
Country
Japan
Facility Name
Matsubara Mayflower Hospital
City
Hyogo
ZIP/Postal Code
673-1462
Country
Japan
Facility Name
Yoshida Orthopaedic and Rheumatology Clinic
City
Iwate
ZIP/Postal Code
020-0015
Country
Japan
Facility Name
Eiraku Clinic
City
Kagoshima
ZIP/Postal Code
890-0055
Country
Japan
Facility Name
Izumihara Rheumatic and Medical Clinic
City
Kagoshima
ZIP/Postal Code
890-0067
Country
Japan
Facility Name
Kawasaki Rheumatism and Internal Medicine Clinic
City
Kanagawa
ZIP/Postal Code
212-0014
Country
Japan
Facility Name
Kumamoto Orthopaedic Hospital
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Munakata Yasuhiko Clinic
City
Miyagi
ZIP/Postal Code
980-6166
Country
Japan
Facility Name
Yu-Family Clinic
City
Miyagi
ZIP/Postal Code
981-0112
Country
Japan
Facility Name
Sendai Taihaku Hospital
City
Miyagi
ZIP/Postal Code
982-0032
Country
Japan
Facility Name
Kai Clinic
City
Miyazaki
ZIP/Postal Code
880-0053
Country
Japan
Facility Name
Zenjinkai Shimin no Mori Hospital
City
Miyazaki
ZIP/Postal Code
880-0122
Country
Japan
Facility Name
Komagamine Orthopaedic Rheumatic Clinic
City
Morioka Iwate
ZIP/Postal Code
020-0034
Country
Japan
Facility Name
Nagasaki Medical Hospital of Rheumatology
City
Nagasaki
ZIP/Postal Code
850-0832
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
SaSebo Chuo Hospital
City
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
Oribe Clinic of Rheumatism and Medicine
City
Oita
ZIP/Postal Code
870-0823
Country
Japan
Facility Name
Otsuka Clinica of Rheumatism and Medicine
City
Oita
ZIP/Postal Code
870-1155
Country
Japan
Facility Name
Rinku Hashimoto Rheumatology Orthopedics
City
Osaka
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
Koshigaya Municipal Hospital
City
Saitama
ZIP/Postal Code
343-8577
Country
Japan
Facility Name
Medical Corporation Kojyokai Hirose Clinic
City
Saitama
ZIP/Postal Code
359-1111
Country
Japan
Facility Name
Hokkaido Medical Center for Rheumatic Diseases
City
Sapporo
ZIP/Postal Code
063-0811
Country
Japan
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Miyasato Clinic
City
Yamaguchi
ZIP/Postal Code
745-0824
Country
Japan
Facility Name
Tokito Clinic Rheumatology and Orthopaedics, Surgery
City
Yamaguchi
ZIP/Postal Code
752-0976
Country
Japan
Facility Name
Centrum Kliniczno Badawcze
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdyni
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Mazowieckie Centrum Badan Klinicznych (MCBK) SC
City
Grodzisk Mazowiecki
ZIP/Postal Code
05825
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Katowicach
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Centrum Terapii Wspólczesne
City
Kodz
ZIP/Postal Code
90242
Country
Poland
Facility Name
NZOZ Lecznica MAK-MED
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Profmedicus sp. z o.o
City
Olsztyn
ZIP/Postal Code
10696
Country
Poland
Facility Name
Centrum Medyczne SYNEXUS Poznan
City
Poznan
ZIP/Postal Code
60702
Country
Poland
Facility Name
Prywatna Praktyka Lekarska Prof UM dr hab. Med. Pawel Hrycaj
City
Poznan
ZIP/Postal Code
61-639
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warszawa
ZIP/Postal Code
01518
Country
Poland
Facility Name
Biogenes NZOZ
City
Wroclaw
ZIP/Postal Code
53-224
Country
Poland
Facility Name
Synexus Polska Sp. z o.o
City
Wroclaw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Sverdlovsk Regional Clinical Hospital #1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Krasnoyarsk Medical Academy
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
State Healthcare Institution of Moscow City Clinical Hospital #15 n.a. O.M. Filatov
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Practicheskaya Meditsina, Ltd
City
Moscow
ZIP/Postal Code
115404
Country
Russian Federation
Facility Name
Republican Hospital n.a. V.A. Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Smolensk State Medical University (SSMU)
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "Consultative diagnostic center #85
City
St Petersburg
ZIP/Postal Code
198260
Country
Russian Federation
Facility Name
Medical Research Institute, LLC
City
St. Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Municipal Healthcare Institution "Emergency Clinical Hospital n.a. N.V. Soloviev
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
MBI "Central City Clinical Hospital #6
City
Yekaterinburg
ZIP/Postal Code
620149
Country
Russian Federation
Facility Name
Dr CI Louw
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Dr S Nayiager
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Wits Donald Gordon Clinical Trial Site
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Drs Dindar and Partners
City
Mpumalanga
ZIP/Postal Code
2330
Country
South Africa
Facility Name
Private Practice - Cathy Spargo
City
Pinelands
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Jakaranda Hospital Pretoria
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Winelands Rheumatology Centre
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN25PE
Country
United Kingdom
Facility Name
Harrogate District NHS Foundation Trust
City
Harrogate
ZIP/Postal Code
HG27SX
Country
United Kingdom
Facility Name
Wirral University Teaching Hospital NHS Foundation Trust
City
Merseyside
ZIP/Postal Code
CH495PE
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)

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