At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,307 enrolled
Drug / intervention
Adalimumab +4 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 Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy
In Brief
A Phase 3 clinical trial evaluating Adalimumab, Baricitinib, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 1,307 participants across 213 sites in 28 countries.
Detailed Summary
The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Belgium, Canada, China, Croatia, Czechia, France, Germany, Greece, Hungary, Japan, Latvia, Lithuania, Mexico, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedOct 2012
Primary CompletionMar 2015
Study CompletionSep 2015
TodayJul 2026
First PostedOct 19, 2012
Enrollment StartOct 1, 2012
Primary CompletionMar 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.7 years ago
Interventions
Adalimumabdrug
Administered SC
Baricitinibdrug
Administered orally
Methotrexatedrug
Administered orally
Adalimumab Placebodrug
Adalimumab placebo administered SC.
Baricitinib Placebodrug
Baricitinib placebo administered orally.