At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 395 enrolled
Drug / intervention
adalimumab +1 morebiological
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 Double-Blind, Randomized, Parallel-Arm, Multicenter Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy With Adalimumab in Subjects With Early Rheumatoid Arthritis (CONCERTO)
In Brief
A Phase 3 clinical trial evaluating adalimumab and methotrexate for Early Rheumatoid Arthritis. Completed, enrolled 395 participants across 68 sites in 10 countries.
Detailed Summary
The purpose of this study is to determine the effects of different doses of methotrexate (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Rheumatoid Arthritis
CountriesArgentina, Austria, Belgium, Canada, Czechia, Germany, Poland, Puerto Rico, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartOct 2010
Primary CompletionSep 2012
TodayJul 2026
First PostedAug 19, 2010
Enrollment StartOct 1, 2010
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.9 years ago
Interventions
adalimumabbiological
Pre-filled syringe every other week
methotrexatedrug
weekly oral capsule dosing