ETA305
Research type
Research Study
Full title
An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05)
IRAS ID
180728
Contact name
Barbara Finck
Contact email
Sponsor organisation
Coherus BioSciences, Inc.
Eudract number
2015-000665-30
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
The purpose of this extension study is to evaluate the longer-term safety and durability of responses of patients who have successfully completed 48 weeks of evaluations in the confirmatory CHS-0214 safety and efficacy studies CHS-0214-02 and CHS-0214-04 in rheumatoid arthritis (RA) and Psoriasis (PsO) respectively.
Both RA and Pso are autoimmune inflammatory diseases. Psoriasis is an inflammatory skin condition, caused by an overactive immune system, and rheumatoid arthritis causes pain, swelling and inflammation of the joints. Currently there is no cure for either of these indications.
Tumour necrosis factor (TNF) is a naturally occurring molecule that plays an important role in the inflammatory process for these diseases.
High levels of TNF are found in tissues and fluids of patients with Pso and RA. 2 distinct types of TNF receptor are found on cell surfaces and in the surrounding areas.
Etancercept (Enbrel), a biologic drug, is a soluble form of this receptor that can bind to TNF and make it biologically inactive. Biologic drugs 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 open label extension study will continue to compare the effectiveness and safety of a biosimilar investigational drug developed by Coherus Biosciences, Inc. (CHS0214). Open label means that all the participants will receive CHS-0214.
This is a multicenter multinational study which will be conducted in about 130 centres globally. Approximately 400 men and women aged 18 years or older will take part.
The study will last approximately 52 weeks, and the participant will receive the study medication on a weekly basis for 48 weeks.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0249
Date of REC Opinion
30 Jul 2015
REC opinion
Favourable Opinion