Coherus ETA302 - RA
Research type
Research Study
Full 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
IRAS ID
157357
Contact name
Kevin Davies
Contact email
Sponsor organisation
Coherus Biosciences Inc
Eudract number
2014-000443-33
Research summary
Rheumatoid arthritis (RA) is a chronic (long-lasting), progressive auto-immune disease that causes pain, swelling and inflammation of the joints, most commonly in the fingers, wrists, feet and ankles.
There is no known cure for RA. Current therapies include disease-modifying anti-rheumatic drugs (DMARDs) which suppress inflammation and help to delay progression of the disease, or non-steroidal anti-inflammatory drugs (NSAIDs) which ease pain. In the most severe cases, biologic drugs such as Enbrel® may be used. By targeting specific components of the immune system, biologics block the naturally-occurring proteins that contribute to the inflammatory process. They are manufactured in cultured cells and vary depending on culture conditions, meaning that biologic drugs cannot be considered ‘identical’ but may be considered biosimilar.
This study will compare the effectiveness and safety of a biosimilar investigational drug developed by Coherus Biosciences, Inc. (CHS-0214) with EU-approved reference drug Enbrel®, administered weekly for 24 weeks in patients with RA. The long-term effectiveness and safety of open-label CHS-0214 will then be evaluated from 25 to 48 weeks.
This is a double-blind, randomised, active control study meaning that neither the patient nor the study doctor will know which medication is being given and that no participant will receive a placebo (a drug that has no medical effect).
This is a multicentre study which will take place across Europe, United States, Japan, Brazil and Israel. It is anticipated that approximately 486 patients will be enrolled worldwide, 5 of those in the UK.REC name
London - West London & GTAC Research Ethics Committee
REC reference
14/LO/1435
Date of REC Opinion
20 Oct 2014
REC opinion
Further Information Favourable Opinion