At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 309 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 Multicenter, Double-Blind, Randomized, Parallel-Arm Study to Determine the Effect of Methotrexate Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis Treated With Adalimumab (MUSICA)
In Brief
A Phase 4 clinical trial evaluating Adalimumab and Methotrexate for Rheumatoid Arthritis. Completed, enrolled 309 participants across 49 sites in 2 countries.
Detailed Summary
This study will investigate the efficacy of both low and high doses of methotrexate (MTX) in combination with open-label adalimumab (ADA) in patients who have had an inadequate response to high dose of MTX. The study will also evaluate the pharmacokinetics and safety of the two regimens of MTX in combination with ADA in participants with rheumatoid arthritis (RA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartSep 2010
Primary CompletionJan 2013
TodayJul 2026
First PostedAug 19, 2010
Enrollment StartSep 1, 2010
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.9 years ago
Interventions
Adalimumabbiological
Adalimumab in pre-filled syringes
Methotrexatedrug
Methotrexate capsule