At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 376 enrolled
Drug / intervention
GP2015drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating GP2015 for Rheumatoid Arthritis. Completed, enrolled 376 participants across 92 sites in 16 countries.
Detailed Summary
Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBulgaria, Czechia, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Poland, Russia, Serbia, Slovakia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartFeb 2015
First PostedDec 2015
Primary CompletionDec 2016
Study CompletionJun 2017
TodayJul 2026
First PostedDec 23, 2015
Enrollment StartFeb 21, 2015
Primary CompletionDec 29, 2016
Study CompletionJun 12, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.5 years ago
Interventions
GP2015drug
Enbrel comparator