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Rheumatoid ArthritisPhase 3CHS-0214-02NCT02115750

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

A Phase 3 study testing Etanercept and CHS-0214 in people with Rheumatoid Arthritis, run by Coherus Oncology, Inc. at 141 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Etanercept and CHS-0214
Could I receive a placebo?
No, everyone receives an active treatment
How many people
647 participants
Where
141 sitesin 12 countries
Study dates
May 2014to May 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Major systemic infections
  • Presence of significant comorbid conditions
  • Known allergy to latex
  • Women who are pregnant or nursing

Trial locations and contacts

141 sites in 12 countries.

141 sites in 12 countries

Japan40 sites

  • Japanese Red Cross Nagoya Daiichi Hospital

    Aichi, 453-8511

  • Yamada Rheumatology Clinic

    Ehime, 790-0905

  • University of Occupational and Environmental Health Hospital

    Fukuoka, 807-8556

  • Kondo Clinic for Rheumatism and Orthopaedics

    Fukuoka, 810-0001

  • Medical Co. LTA PS Clinic

    Fukuoka, 812-0025

  • Shono Rheumatism Clinic

    Fukuoka, 814-002

  • St Mary;s Hospital

    Fukuoka, 830-8543

  • Hiroshima Rheumatology Clinic

    Hiroshima, 730-0017

  • Medical Corporation Nakayama Clinic

    Hyōgo, 650-0044

  • Matsubara Mayflower Hospital

    Hyōgo, 673-1462

  • Eiraku Clinic

    Kagoshima, 890-0055

  • Izumihara Rheumatic and Medical Clinic

    Kagoshima, 890-0067

  • Kawasaki Rheumatism and Internal Medicine Clinic

    Kanagawa, 212-0014

  • Kumamoto Orthopaedic Hospital

    Kumamoto, 862-0976

  • Munakata Yasuhiko Clinic

    Miyagi, 980-6166

  • Yu-Family Clinic

    Miyagi, 981-0112

  • Sendai Taihaku Hospital

    Miyagi, 982-0032

  • Kai Clinic

    Miyazaki, 880-0053

  • Zenjinkai Shimin no Mori Hospital

    Miyazaki, 880-0122

  • Komagamine Orthopaedic Rheumatic Clinic

    Morioka Iwate, 020-0034

  • Nagasaki Medical Hospital of Rheumatology

    Nagasaki, 850-0832

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • SaSebo Chuo Hospital

    Nagasaki, 857-1195

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Hiroshima Clinic

    Nishiku, Hiroshimashi, 733-0032

  • Yoshida Orthopaedic and Rheumatology Clinic

    Numakunai, 020-0015

  • Oribe Clinic of Rheumatism and Medicine

    Ōita, 870-0823

  • Otsuka Clinica of Rheumatism and Medicine

    Ōita, 870-1155

  • Japanese Red Cross Okayama Hospital

    Okayama, Okayama-ken, 700-8607

  • Miyashita Rheumatology Clinic

    Omura-shi, Nagasaki, 856-0836

  • Rinku Hashimoto Rheumatology Orthopedics

    Osaka, 598-0048

  • Koshigaya Municipal Hospital

    Saitama, 343-8577

  • Medical Corporation Kojyokai Hirose Clinic

    Saitama, 359-1111

  • Hokkaido Medical Center for Rheumatic Diseases

    Sapporo, 063-0811

  • Izumi Himawari Clinica

    Sendai, Miyagi, 981-3135

  • Inoue Hospital

    Takasaki-shi, Gunma, 370-0053

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • Keio University Hospital

    Tokyo, 160-8582

  • Miyasato Clinic

    Yamaguchi, 745-0824

  • Tokito Clinic Rheumatology and Orthopaedics, Surgery

    Yamaguchi, 752-0976

Other trials in Japan

United States37 sites

  • Dream Team Clinical Research

    Anaheim, California, 92801

  • Texas Physicians Medical Research Group

    Arlington, Texas, 76015

  • IMMUNOe International Research Centers

    Centennial, Colorado, 80112

  • Low Country Rheumatology

    Charleston, South Carolina, 29406

  • DJL Clinical Research

    Charlotte, North Carolina, 28210

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • North Shore University Hospital

    Great Neck, New York, 11021

  • Pioneer Research Solutions Inc

    Houston, Texas, 77036

  • Arthritis Clinic

    Jackson, Tennessee, 38305

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Hope Clinical Research

    Kissimmee, Florida, 34741

  • Advanced Medical Research

    Lakewood, California, 90712

  • Bluegrass Community Research, Inc

    Lexington, Kentucky, 40504

  • Arthritis Center of Nebraska

    Lincoln, Nebraska, 68516

  • Pro Health Partners

    Long Beach, California, 90808

  • Pacific Arthritis Center Medical Group

    Omaha, Nebraska, 68198

  • Rheumatoid Arthritis Investigational Network

    Omaha, Nebraska, 68198

  • Gundersen Lutheran Medical Center

    Onalaska, Wisconsin, 54650

  • St. Joseph Hospital of Orange

    Orange, California, 92868

  • Advanced Medical Research, Inc

    Orlando, Florida, 32804

  • Desert Medical Advances

    Palm Desert, California, 92260

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • Arizona Research Center

    Phoenix, Arizona, 85020

  • Kaiser Permanente - CA

    Richmond, California, 94801

  • Med Investigators, Inc

    Roseville, California, 95661

  • Troum Medical Associates

    Santa Monica, California, 90404

  • Arthritis Northwest Rheumatology PLLC

    Spokane, Washington, 99204

  • St. Louis Center for Clinical Research

    St Louis, Missouri, 63128

  • Allergy & Rheumatology Associates LLC

    St. Petersburg, Florida, 33708

  • HealthPoint Medical Group

    Tampa, Florida, 33614

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Inland Rheumatology Clinical Trials Inc

    Upland, California, 91786

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • PMG Research of Wilmington LLC

    Wilmington, North Carolina, 28401

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01605

Other trials in United States

Poland13 sites

  • Centrum Kliniczno Badawcze

    Elblag, 82-300

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

    Gdynia, 81-384

  • Mazowieckie Centrum Badan Klinicznych (MCBK) SC

    Grodzisk Mazowiecki, 05825

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

    Katowice, 40-040

  • Centrum Terapii Wspólczesne

    Kodz, 90242

  • NZOZ Lecznica MAK-MED

    Nadarzyn, 05-830

  • Profmedicus sp. z o.o

    Olsztyn, 10696

  • Centrum Medyczne SYNEXUS Poznan

    Poznan, 60702

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

    Poznan, 61-639

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

    Warsaw, 01-192

  • Centrum Medyczne AMED

    Warsaw, 01518

  • Biogenes NZOZ

    Wroclaw, 53-224

  • Synexus Polska Sp. z o.o

    Wroclaw, 53-413

Other trials in Poland

Russia10 sites

  • Krasnoyarsk Medical Academy

    Krasnoyarsk, 660022

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

    Moscow, 111539

  • Practicheskaya Meditsina, Ltd

    Moscow, 115404

  • Republican Hospital n.a. V.A. Baranov

    Petrozavodsk, 185019

  • Medical Research Institute, LLC

    Saint Petersburg, 196084

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

    Saint Petersburg, 198260

  • Smolensk State Medical University (SSMU)

    Smolensk, 214019

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

    Yaroslavl, 150003

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

  • MBI "Central City Clinical Hospital #6

    Yekaterinburg, 620149

Other trials in Russia

South Africa8 sites

  • Dr CI Louw

    Cape Town, 7500

  • Dr S Nayiager

    Durban, 4001

  • Wits Donald Gordon Clinical Trial Site

    Johannesburg, 2193

  • Drs Dindar and Partners

    Mpumalanga, 2330

  • Private Practice - Cathy Spargo

    Pinelands, 7405

  • Jakaranda Hospital Pretoria

    Pretoria, 0002

  • Emmed Research

    Pretoria, 0084

  • Winelands Rheumatology Centre

    Stellenbosch, 7600

Other trials in South Africa

Hungary7 sites

  • St. Rokus Hospital, BAJA

    Baja, 6500

  • DRC Gyogzszervizsgalo Kozpont

    Balatonfüred, 8230

  • Orszagos Reumatologiai es Fizioterapias Intezet

    Budapest, 1023

  • Qualiclinic Kft

    Budapest, 1036

  • Békés Megyei Pándy Kálmán Kórház

    Gyula, 5700

  • University of Szeged, Faculty of Medicine

    Szeged, 6725

  • Rakoczi Ferenc Korhaz-CRU Hungary (KFT)

    Szikszó, 3800

Other trials in Hungary

Belarus6 sites

  • Brest Regional Clinical Hospital

    Brest, 224027

  • Grodno Regional Clinical Hospital

    Grodno, 230017

  • Gomel Regional Clinical Hospital

    Homyel, 246029

  • City Clinical Hospital #1 - Belarus

    Minsk, 220013

  • City Clinical Hospital #9 - Belarus

    Minsk, 220116

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037

Other trials in Belarus

France5 sites

  • Hôpital Michallon - CHU de Grenobl

    Grenoble, 38434

  • CHU Bicetre

    Le Kremlin-Bicêtre, 94275

  • Centre Hospitalier Regional D'Orleans

    Orléans, 45067

  • Hopital Cochin-Saint Vincent de Paul

    Paris, 75014

  • Hopital de Saint Etienne

    Saint-Etienne, 42055

Other trials in France

Germany5 sites

  • Asklepios Klinikum Bad Abbach

    Bad Abbach, 93077

  • Klinische Forschung Dresden GmbH

    Dresden, 01069

  • Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology

    Frankfurt, 60528

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • SMO.MD GmbH - Zentrum fuer klinische Studien

    Magdeburg, 39112

Other trials in Germany

Israel4 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Sheba Medical Center

    Tel HaShomer, 52621

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

Spain3 sites

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Málaga

    Málaga, 29009

Other trials in Spain

United Kingdom3 sites

  • Royal Sussex County Hospital

    Brighton, BN25PE

  • Harrogate District NHS Foundation Trust

    Harrogate, HG27SX

  • Wirral University Teaching Hospital NHS Foundation Trust

    Merseyside, CH495PE

Other trials in United Kingdom

About this study

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

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.

Being tested
Etanercept, CHS-0214
Keywords
CHS-0214, Enbrel, RA, Biosimilar, Etanercept
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtanerceptDrug

    Also called Enbrel, European Enbrel

    Head-to-head comparison

  • CHS-0214Drug

Study groups in NCT02115750
Study groupRoleWhat they receive
Enbrel (etanercept)Active comparatorEnbrel 50mg weekly times 24 weeks.
Receives: Drug: Etanercept
CHS-0214ExperimentalCHS-0214 50mg weekly times 24 weeks.
Receives: Drug: CHS-0214

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 24-weeks

Secondary outcomes (6)

  1. 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).

    Measured: Weeks 4, 8, 12 and 18

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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).

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

  6. 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".

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionOct 2015
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
647 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02115750
Sponsor's protocol ID
CHS-0214-02
Acronym
CHS-0214-02
Status last verified
Jun 2019
First submitted
14 Apr 2014
Last updated
26 Jun 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etanercept and CHS-0214 in people with Rheumatoid Arthritis, run by Coherus Oncology, Inc. at 141 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in Japan, United States, Poland, Russia, South Africa and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACR-20 - 20% Improvement According to American College of Rheumatology Criteria (time frame: 24-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02115750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.

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