NCT01185288

A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab	Adalimumab in pre-filled syringes
DRUG	Methotrexate	Methotrexate capsule

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2010-08-19
• Last updated: 2014-03-18
• Results posted: 2014-03-18

Locations

49 sites across 2 countries: United States, Puerto Rico