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

NCT02115750 | Completed Phase 3 Results DMC

• 1 other identifier: CHS-0214-02
• Study Type: interventional
• Target: 647
• Locations: 12 countries
• Sites: 141

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.

Conditions

Rheumatoid Arthritis

Keywords

CHS-0214; Enbrel; RA; Biosimilar; Etanercept

Outcome Measures

Primary Outcomes (1)

• 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)

  24-weeks

Secondary Outcomes (6)

• ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18

  Weeks 4, 8, 12 and 18

• Summary of Change in Tender Joint Count (TJC) by Study Visit

  Weeks 4,8,12,18,24,28,36,48

• Summary of Change in Swollen Joint Count (SJC) by Study Visit

  Weeks 4,8,12,18,24,28,36,48

• Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit

  Weeks 4,8,12,18,24,28,36,48

• Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit

  Weeks 4,8,12,18,24,28,36,48

Study Arms (2)

Enbrel (etanercept)

ACTIVE COMPARATOR

Enbrel 50mg weekly times 24 weeks.

Drug: Etanercept

CHS-0214

EXPERIMENTAL

CHS-0214 50mg weekly times 24 weeks.

Drug: CHS-0214

Interventions

Etanercept DRUG

Head-to-head comparison

Also known as: Enbrel, European Enbrel

Enbrel (etanercept)

CHS-0214 DRUG

CHS-0214

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coherus Oncology, Inc.: lead
• Daiichi Sankyo Co., Ltd.: collaborator

Study Sites (141)

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

Arizona Research Center

Phoenix, Arizona, 85020, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

Dream Team Clinical Research

Anaheim, California, 92801, United States

Location

Advanced Medical Research

Lakewood, California, 90712, United States

Location

Pro Health Partners

Long Beach, California, 90808, United States

Location

St. Joseph Hospital of Orange

Orange, California, 92868, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Kaiser Permanente - CA

Richmond, California, 94801, United States

Location

Med Investigators, Inc

Roseville, California, 95661, United States

Location

Troum Medical Associates

Santa Monica, California, 90404, United States

Location

Inland Rheumatology Clinical Trials Inc

Upland, California, 91786, United States

Location

IMMUNOe International Research Centers

Centennial, Colorado, 80112, United States

Location

Hope Clinical Research

Kissimmee, Florida, 34741, United States

Location

Advanced Medical Research, Inc

Orlando, Florida, 32804, United States

Location

Allergy & Rheumatology Associates LLC

St. Petersburg, Florida, 33708, United States

Location

HealthPoint Medical Group

Tampa, Florida, 33614, United States

Location

Bluegrass Community Research, Inc

Lexington, Kentucky, 40504, United States

Location

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

St. Louis Center for Clinical Research

St Louis, Missouri, 63128, United States

Location

Arthritis Center of Nebraska

Lincoln, Nebraska, 68516, United States

Location

Pacific Arthritis Center Medical Group

Omaha, Nebraska, 68198, United States

Location

Rheumatoid Arthritis Investigational Network

Omaha, Nebraska, 68198, United States

Location

North Shore University Hospital

Great Neck, New York, 11021, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

DJL Clinical Research

Charlotte, North Carolina, 28210, United States

Location

PMG Research of Wilmington LLC

Wilmington, North Carolina, 28401, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Low Country Rheumatology

Charleston, South Carolina, 29406, United States

Location

Arthritis Clinic

Jackson, Tennessee, 38305, United States

Location

Texas Physicians Medical Research Group

Arlington, Texas, 76015, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Pioneer Research Solutions Inc

Houston, Texas, 77036, United States

Location

Arthritis Northwest Rheumatology PLLC

Spokane, Washington, 99204, United States

Location

Rheumatic Disease Center

Glendale, Wisconsin, 53217, United States

Location

Gundersen Lutheran Medical Center

Onalaska, Wisconsin, 54650, United States

Location

Brest Regional Clinical Hospital

Brest, 224027, Belarus

Location

Grodno Regional Clinical Hospital

Grodno, 230017, Belarus

Location

Gomel Regional Clinical Hospital

Homyel, 246029, Belarus

Location

City Clinical Hospital #1 - Belarus

Minsk, 220013, Belarus

Location

City Clinical Hospital #9 - Belarus

Minsk, 220116, Belarus

Location

Vitebsk Regional Clinical Hospital

Vitebsk, 210037, Belarus

Location

Hôpital Michallon - CHU de Grenobl

Grenoble, 38434, France

Location

CHU Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Centre Hospitalier Regional D'Orleans

Orléans, 45067, France

Location

Hopital Cochin-Saint Vincent de Paul

Paris, 75014, France

Location

Hopital de Saint Etienne

Saint-Etienne, 42055, France

Location

Asklepios Klinikum Bad Abbach

Bad Abbach, 93077, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology

Frankfurt, 60528, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

SMO.MD GmbH - Zentrum fuer klinische Studien

Magdeburg, 39112, Germany

Location

St. Rokus Hospital, BAJA

Baja, 6500, Hungary

Location

DRC Gyogzszervizsgalo Kozpont

Balatonfüred, 8230, Hungary

Location

Orszagos Reumatologiai es Fizioterapias Intezet

Budapest, 1023, Hungary

Location

Qualiclinic Kft

Budapest, 1036, Hungary

Location

Békés Megyei Pándy Kálmán Kórház

Gyula, 5700, Hungary

Location

University of Szeged, Faculty of Medicine

Szeged, 6725, Hungary

Location

Rakoczi Ferenc Korhaz-CRU Hungary (KFT)

Szikszó, 3800, Hungary

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Inoue Hospital

Takasaki-shi, Gunma, 370-0053, Japan

Location

Hiroshima Clinic

Nishiku, Hiroshimashi, 733-0032, Japan

Location

Izumi Himawari Clinica

Sendai, Miyagi, 981-3135, Japan

Location

Miyashita Rheumatology Clinic

Omura-shi, Nagasaki, 856-0836, Japan

Location

Japanese Red Cross Okayama Hospital

Okayama, Okayama-ken, 700-8607, Japan

Location

Japanese Red Cross Nagoya Daiichi Hospital

Aichi, 453-8511, Japan

Location

Yamada Rheumatology Clinic

Ehime, 790-0905, Japan

Location

University of Occupational and Environmental Health Hospital

Fukuoka, 807-8556, Japan

Location

Kondo Clinic for Rheumatism and Orthopaedics

Fukuoka, 810-0001, Japan

Location

Medical Co. LTA PS Clinic

Fukuoka, 812-0025, Japan

Location

Shono Rheumatism Clinic

Fukuoka, 814-002, Japan

Location

St Mary;s Hospital

Fukuoka, 830-8543, Japan

Location

Hiroshima Rheumatology Clinic

Hiroshima, 730-0017, Japan

Location

Medical Corporation Nakayama Clinic

Hyōgo, 650-0044, Japan

Location

Matsubara Mayflower Hospital

Hyōgo, 673-1462, Japan

Location

Eiraku Clinic

Kagoshima, 890-0055, Japan

Location

Izumihara Rheumatic and Medical Clinic

Kagoshima, 890-0067, Japan

Location

Kawasaki Rheumatism and Internal Medicine Clinic

Kanagawa, 212-0014, Japan

Location

Kumamoto Orthopaedic Hospital

Kumamoto, 862-0976, Japan

Location

Munakata Yasuhiko Clinic

Miyagi, 980-6166, Japan

Location

Yu-Family Clinic

Miyagi, 981-0112, Japan

Location

Sendai Taihaku Hospital

Miyagi, 982-0032, Japan

Location

Kai Clinic

Miyazaki, 880-0053, Japan

Location

Zenjinkai Shimin no Mori Hospital

Miyazaki, 880-0122, Japan

Location

Komagamine Orthopaedic Rheumatic Clinic

Morioka Iwate, 020-0034, Japan

Location

Nagasaki Medical Hospital of Rheumatology

Nagasaki, 850-0832, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

SaSebo Chuo Hospital

Nagasaki, 857-1195, Japan

Location

Yoshida Orthopaedic and Rheumatology Clinic

Numakunai, 020-0015, Japan

Location

Rinku Hashimoto Rheumatology Orthopedics

Osaka, 598-0048, Japan

Location

Oribe Clinic of Rheumatism and Medicine

Ōita, 870-0823, Japan

Location

Otsuka Clinica of Rheumatism and Medicine

Ōita, 870-1155, Japan

Location

Koshigaya Municipal Hospital

Saitama, 343-8577, Japan

Location

Medical Corporation Kojyokai Hirose Clinic

Saitama, 359-1111, Japan

Location

Hokkaido Medical Center for Rheumatic Diseases

Sapporo, 063-0811, Japan

Location

St. Luke's International Hospital

Tokyo, 104-8560, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Miyasato Clinic

Yamaguchi, 745-0824, Japan

Location

Tokito Clinic Rheumatology and Orthopaedics, Surgery

Yamaguchi, 752-0976, Japan

Location

Centrum Kliniczno Badawcze

Elblag, 82-300, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Gdyni

Gdynia, 81-384, Poland

Location

Mazowieckie Centrum Badan Klinicznych (MCBK) SC

Grodzisk Mazowiecki, 05825, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Katowicach

Katowice, 40-040, Poland

Location

Centrum Terapii Wspólczesne

Kodz, 90242, Poland

Location

NZOZ Lecznica MAK-MED

Nadarzyn, 05-830, Poland

Location

Profmedicus sp. z o.o

Olsztyn, 10696, Poland

Location

Centrum Medyczne SYNEXUS Poznan

Poznan, 60702, Poland

Location

Prywatna Praktyka Lekarska Prof UM dr hab. Med. Pawel Hrycaj

Poznan, 61-639, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Warszawie

Warsaw, 01-192, Poland

Location

Centrum Medyczne AMED

Warsaw, 01518, Poland

Location

Biogenes NZOZ

Wroclaw, 53-224, Poland

Location

Synexus Polska Sp. z o.o

Wroclaw, 53-413, Poland

Location

Krasnoyarsk Medical Academy

Krasnoyarsk, 660022, Russia

Location

State Healthcare Institution of Moscow City Clinical Hospital #15 n.a. O.M. Filatov

Moscow, 111539, Russia

Location

Practicheskaya Meditsina, Ltd

Moscow, 115404, Russia

Location

Republican Hospital n.a. V.A. Baranov

Petrozavodsk, 185019, Russia

Location

Medical Research Institute, LLC

Saint Petersburg, 196084, Russia

Location

St. Petersburg State Healthcare Institution "Consultative diagnostic center #85

Saint Petersburg, 198260, Russia

Location

Smolensk State Medical University (SSMU)

Smolensk, 214019, Russia

Location

Municipal Healthcare Institution "Emergency Clinical Hospital n.a. N.V. Soloviev

Yaroslavl, 150003, Russia

Location

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, 620102, Russia

Location

MBI "Central City Clinical Hospital #6

Yekaterinburg, 620149, Russia

Location

Dr CI Louw

Cape Town, 7500, South Africa

Location

Dr S Nayiager

Durban, 4001, South Africa

Location

Wits Donald Gordon Clinical Trial Site

Johannesburg, 2193, South Africa

Location

Drs Dindar and Partners

Mpumalanga, 2330, South Africa

Location

Private Practice - Cathy Spargo

Pinelands, 7405, South Africa

Location

Jakaranda Hospital Pretoria

Pretoria, 0002, South Africa

Location

Emmed Research

Pretoria, 0084, South Africa

Location

Winelands Rheumatology Centre

Stellenbosch, 7600, South Africa

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29009, Spain

Location

Royal Sussex County Hospital

Brighton, BN25PE, United Kingdom

Location

Harrogate District NHS Foundation Trust

Harrogate, HG27SX, United Kingdom

Location

Wirral University Teaching Hospital NHS Foundation Trust

Merseyside, CH495PE, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Barbara K. Finck, MD Chief Medical Officer
• Organization: Coherus BioSciences, Inc

Bfinck@coherus.com

650-649-3529

Study Officials

• Barbara K Finck, M.D.

  Coherus Oncology, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: May 1, 2016
• Last Updated: June 26, 2019
• Results First Posted: June 26, 2019

Record last verified: 2019-06

Locations

JP (40); FR (5); DE (5); US (37); BE (6); RU (10); ZA (8); HU (7); GB (3); IL (4); PL (13); ES (3)