Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA) (CHS-0214-02)
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|ClinicalTrials.gov Identifier: NCT02115750|
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : October 12, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Etanercept Drug: CHS-0214||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||647 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||May 2016|
Active Comparator: Enbrel (etanercept)
Enbrel 50mg weekly times 24 weeks.
CHS-0214 50mg weekly times 24 weeks.
- ACR-20 [ Time Frame: 24-weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115750
Show 141 Study Locations
|Study Director:||Barbara K Finck, M.D.||Coherus Biosciences, Inc.|