At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,004 enrolled
Drug / intervention
LY2127399 +1 moredrug
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 Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)
In Brief
A Phase 3 clinical trial evaluating LY2127399 and Placebo for Rheumatoid Arthritis. Completed, enrolled 1,004 participants across 213 sites in 22 countries.
Detailed Summary
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic drug (DMARD) therapy. This study is comprised of 2 periods: Period 1 - 24-week blinded treatment Period 2 - 48-week post-treatment follow-up
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Bulgaria, Colombia, Croatia, Hungary, India, Japan, Lithuania, Malaysia, Mexico, New Zealand, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Sri Lanka, Taiwan, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartJan 2011
Primary CompletionDec 2012
Study CompletionJul 2013
TodayJul 2026
First PostedSep 16, 2010
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2012
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.8 years ago
Interventions
LY2127399drug
Placebodrug