Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
- Registration Number
- NCT02115750
- Lead Sponsor
- Coherus Biosciences, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 647
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enbrel (etanercept) Etanercept Enbrel 50mg weekly times 24 weeks. CHS-0214 CHS-0214 CHS-0214 50mg weekly times 24 weeks.
- Primary Outcome Measures
Name Time Method ACR-20 - 20% Improvement According to American College of Rheumatology Criteria 24-weeks 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
Name Time Method Summary of Change in Tender Joint Count (TJC) by Study Visit Weeks 4,8,12,18,24,28,36,48 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.
ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18 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 Swollen Joint Count (SJC) by Study Visit Weeks 4,8,12,18,24,28,36,48 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 Weeks 4,8,12,18,24,28,36,48 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 Weeks 4,8,12,18,24,28,36,48 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 Weeks 4,8,12,18,24,28,36,48 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".
Trial Locations
- Locations (141)
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Dream Team Clinical Research
🇺🇸Anaheim, California, United States
Arthritis Center of Nebraska
🇺🇸Lincoln, Nebraska, United States
Rheumatic Disease Center
🇺🇸Glendale, Wisconsin, United States
Pioneer Research Solutions Inc
🇺🇸Houston, Texas, United States
Yu-Family Clinic
🇯🇵Miyagi, Japan
Advanced Medical Research
🇺🇸Lakewood, California, United States
Pro Health Partners
🇺🇸Long Beach, California, United States
Desert Medical Advances
🇺🇸Palm Desert, California, United States
Troum Medical Associates
🇺🇸Santa Monica, California, United States
Kaiser Permanente - CA
🇺🇸Richmond, California, United States
Med Investigators, Inc
🇺🇸Roseville, California, United States
IMMUNOe International Research Centers
🇺🇸Centennial, Colorado, United States
Advanced Medical Research, Inc
🇺🇸Orlando, Florida, United States
Inland Rheumatology Clinical Trials Inc
🇺🇸Upland, California, United States
Allergy & Rheumatology Associates LLC
🇺🇸Saint Petersburg, Florida, United States
Hope Clinical Research
🇺🇸Kissimmee, Florida, United States
Bluegrass Community Research, Inc
🇺🇸Lexington, Kentucky, United States
The Center for Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
St. Louis Center for Clinical Research
🇺🇸Saint Louis, Missouri, United States
PMG Research of Wilmington LLC
🇺🇸Wilmington, North Carolina, United States
DJL Clinical Research
🇺🇸Charlotte, North Carolina, United States
North Shore University Hospital
🇺🇸Great Neck, New York, United States
Low Country Rheumatology
🇺🇸Charleston, South Carolina, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Texas Physicians Medical Research Group
🇺🇸Arlington, Texas, United States
Arthritis Clinic
🇺🇸Jackson, Tennessee, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Arthritis Northwest Rheumatology PLLC
🇺🇸Spokane, Washington, United States
Brest Regional Clinical Hospital
🇧🇾Brest, Belarus
Gundersen Lutheran Medical Center
🇺🇸Onalaska, Wisconsin, United States
City Clinical Hospital #9 - Belarus
🇧🇾Minsk, Belarus
City Clinical Hospital #1 - Belarus
🇧🇾Minsk, Belarus
Grodno Regional Clinical Hospital
🇧🇾Grodno, Belarus
Hôpital Michallon - CHU de Grenobl
🇫🇷Grenoble, France
CHU Bicetre
🇫🇷Le Kremlin-Bicetre, France
Centre Hospitalier Regional D'Orleans
🇫🇷Orleans Cedex, France
Hopital Cochin-Saint Vincent de Paul
🇫🇷Paris, France
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Germany
Hopital de Saint Etienne
🇫🇷Saint-Etienne, France
Asklepios Klinikum Bad Abbach
🇩🇪Bad Abbach, Germany
Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology
🇩🇪Frankfurt, Germany
Universitätsmedizin Göttingen
🇩🇪Gottingen, Germany
SMO.MD GmbH - Zentrum fuer klinische Studien
🇩🇪Magdeburg, Germany
St. Rokus Hospital, BAJA
🇭🇺Baja, Hungary
Rakoczi Ferenc Korhaz-CRU Hungary (KFT)
🇭🇺Szikszo, Hungary
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Assaf Harofeh Medical Center
🇮🇱Zerifin, Israel
Hiroshima Clinic
🇯🇵Nishi-ku, Hiroshimashi, Japan
Izumi Himawari Clinica
🇯🇵Sendai-City, Miyagi, Japan
Yamada Rheumatology Clinic
🇯🇵Ehime, Japan
Shono Rheumatism Clinic
🇯🇵Fukuoka-shi, Japan
University of Occupational and Environmental Health Hospital
🇯🇵Fukuoka, Japan
Medical Co. LTA PS Clinic
🇯🇵Fukuoka, Japan
Hiroshima Rheumatology Clinic
🇯🇵Hiroshima, Japan
Izumihara Rheumatic and Medical Clinic
🇯🇵Kagoshima, Japan
Munakata Yasuhiko Clinic
🇯🇵Miyagi, Japan
Komagamine Orthopaedic Rheumatic Clinic
🇯🇵Morioka Iwate, Japan
Zenjinkai Shimin no Mori Hospital
🇯🇵Miyazaki, Japan
Kai Clinic
🇯🇵Miyazaki, Japan
Nagasaki Medical Hospital of Rheumatology
🇯🇵Nagasaki, Japan
Koshigaya Municipal Hospital
🇯🇵Saitama, Japan
SaSebo Chuo Hospital
🇯🇵Nagasaki, Japan
Otsuka Clinica of Rheumatism and Medicine
🇯🇵Oita, Japan
Rinku Hashimoto Rheumatology Orthopedics
🇯🇵Osaka, Japan
Medical Corporation Kojyokai Hirose Clinic
🇯🇵Saitama, Japan
St. Luke's International Hospital
🇯🇵Tokyo, Japan
Hokkaido Medical Center for Rheumatic Diseases
🇯🇵Sapporo, Japan
Centrum Kliniczno Badawcze
🇵🇱Elblag, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
🇵🇱Gdynia, Poland
Mazowieckie Centrum Badan Klinicznych (MCBK) SC
🇵🇱Grodzisk Mazowiecki, Poland
Centrum Medyczne SYNEXUS Poznan
🇵🇱Poznan, Poland
Prywatna Praktyka Lekarska Prof UM dr hab. Med. Pawel Hrycaj
🇵🇱Poznan, Poland
Biogenes NZOZ
🇵🇱Wroclaw, Poland
Practicheskaya Meditsina, Ltd
🇷🇺Moscow, Russian Federation
Smolensk State Medical University (SSMU)
🇷🇺Smolensk, Russian Federation
MBI "Central City Clinical Hospital #6
🇷🇺Yekaterinburg, Russian Federation
Dr S Nayiager
🇿🇦Durban, South Africa
Wits Donald Gordon Clinical Trial Site
🇿🇦Johannesburg, South Africa
Dr CI Louw
🇿🇦Cape Town, South Africa
Drs Dindar and Partners
🇿🇦Mpumalanga, South Africa
Private Practice - Cathy Spargo
🇿🇦Pinelands, South Africa
Jakaranda Hospital Pretoria
🇿🇦Pretoria, South Africa
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Emmed Research
🇿🇦Pretoria, South Africa
Winelands Rheumatology Centre
🇿🇦Stellenbosch, South Africa
Harrogate District NHS Foundation Trust
🇬🇧Harrogate, United Kingdom
Hospital Regional Universitario de Málaga
🇪🇸Malaga, Spain
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Profmedicus sp. z o.o
🇵🇱Olsztyn, Poland
Centrum Medyczne AMED
🇵🇱Warszawa, Poland
DRC Gyogzszervizsgalo Kozpont
🇭🇺Balatonfured, Hungary
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
Inoue Hospital
🇯🇵Takasaki-shi, Gunma, Japan
Miyashita Rheumatology Clinic
🇯🇵Omura-shi, Nagasaki, Japan
Kondo Clinic for Rheumatism and Orthopaedics
🇯🇵Fukuoka, Japan
Yoshida Orthopaedic and Rheumatology Clinic
🇯🇵Iwate, Japan
Keio University Hospital
🇯🇵Tokyo, Japan
Synexus Polska Sp. z o.o. Oddzial w Katowicach
🇵🇱Katowice, Poland
Békés Megyei Pándy Kálmán Kórház
🇭🇺Gyula, Hungary
Centrum Terapii Wspólczesne
🇵🇱Kodz, Poland
NZOZ Lecznica MAK-MED
🇵🇱Nadarzyn, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
🇵🇱Warszawa, Poland
Krasnoyarsk Medical Academy
🇷🇺Krasnoyarsk, Russian Federation
Eiraku Clinic
🇯🇵Kagoshima, Japan
Vitebsk Regional Clinical Hospital
🇧🇾Vitebsk, Belarus
Qualiclinic Kft
🇭🇺Budapest, Hungary
St. Joseph Hospital of Orange
🇺🇸Orange, California, United States
Kumamoto Orthopaedic Hospital
🇯🇵Kumamoto, Japan
Nagoya University Hospital
🇯🇵Nagoya-shi, Aichi, Japan
Japanese Red Cross Okayama Hospital
🇯🇵Okayama-Shi, Okayama, Japan
Japanese Red Cross Nagoya Daiichi Hospital
🇯🇵Aichi, Japan
St Mary;s Hospital
🇯🇵Fukuoka, Japan
Medical Corporation Nakayama Clinic
🇯🇵Hyogo, Japan
Sverdlovsk Regional Clinical Hospital #1
🇷🇺Ekaterinburg, Russian Federation
Orszagos Reumatologiai es Fizioterapias Intezet
🇭🇺Budapest, Hungary
State Healthcare Institution of Moscow City Clinical Hospital #15 n.a. O.M. Filatov
🇷🇺Moscow, Russian Federation
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Matsubara Mayflower Hospital
🇯🇵Hyogo, Japan
Kawasaki Rheumatism and Internal Medicine Clinic
🇯🇵Kanagawa, Japan
Tokito Clinic Rheumatology and Orthopaedics, Surgery
🇯🇵Yamaguchi, Japan
St. Petersburg State Healthcare Institution "Consultative diagnostic center #85
🇷🇺St Petersburg, Russian Federation
Republican Hospital n.a. V.A. Baranov
🇷🇺Petrozavodsk, Russian Federation
Medical Research Institute, LLC
🇷🇺St. Petersburg, Russian Federation
Oribe Clinic of Rheumatism and Medicine
🇯🇵Oita, Japan
Synexus Polska Sp. z o.o
🇵🇱Wroclaw, Poland
Municipal Healthcare Institution "Emergency Clinical Hospital n.a. N.V. Soloviev
🇷🇺Yaroslavl, Russian Federation
University of Szeged, Faculty of Medicine
🇭🇺Szeged, Hungary
Rambam Medical Center
🇮🇱Haifa, Israel
Sendai Taihaku Hospital
🇯🇵Miyagi, Japan
Gomel Regional Clinical Hospital
🇧🇾Gomel, Belarus
Miyasato Clinic
🇯🇵Yamaguchi, Japan
Pacific Arthritis Center Medical Group
🇺🇸Omaha, Nebraska, United States
Elite Clinical Studies
🇺🇸Phoenix, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Rheumatoid Arthritis Investigational Network
🇺🇸Omaha, Nebraska, United States
HealthPoint Medical Group
🇺🇸Tampa, Florida, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Wirral University Teaching Hospital NHS Foundation Trust
🇬🇧Merseyside, United Kingdom