At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 188 enrolled
Drug / intervention
etanerceptbiological
Likely dose
etanercept 50mgfrom 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 Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating etanercept for Arthritis, Rheumatoid. Completed, enrolled 188 participants across 31 sites in 9 countries.
Detailed Summary
Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesBulgaria, Croatia, Germany, Greece, Hungary, Poland, Serbia, Slovakia, South Africa
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartApr 2015
Primary CompletionMay 2016
Study CompletionJun 2016
TodayJul 2026
First PostedMar 4, 2015
Enrollment StartApr 1, 2015
Primary CompletionMay 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.3 years ago
Interventions
etanerceptbiological
50mg subcutaneous, once weekly, 24 weeks