At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 728 enrolled
Drug / intervention
FKB327 +1 moredrug
Likely dose
FKB327 40 mgfrom 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 Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate
In Brief
A Phase 3 clinical trial evaluating FKB327 and Humira® for Arthritis, Rheumatoid. Completed, enrolled 728 participants across 100 sites in 12 countries.
Detailed Summary
The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesBulgaria, Canada, Chile, Czechia, Germany, Peru, Poland, Romania, Russia, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartDec 2014
Primary CompletionJul 2016
TodayJul 2026
First PostedOct 9, 2014
Enrollment StartDec 1, 2014
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.7 years ago
Interventions
FKB327drug
Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
Humira®drug
Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.