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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2017

At a glance

  • Drugs Etanercept (Primary)
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ETA 302
  • Sponsors Coherus Biosciences; Daiichi Sankyo Company
  • Most Recent Events

    • 27 Sep 2016 According to a Coherus Biosciences media release, the company is on track for submission of a CHS-0214 Marketing Authorization Application (MAA) to the European Medicines Agency in the fourth quarter of 2016. Data from two phase III studies and two pivotal clinical pharmacokinetic studies will support the MAA.
    • 24 Jun 2016 Status changed from active, no longer recruiting to completed.
    • 10 Jun 2016 According to a Coherus BioSciences media release, the company announces study data from this trial at the European League Against Rheumatism Annual European Congress of Rheumatology.
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