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)

Completed · Phase 4

Conditions studied: Rheumatoid Arthritis

In brief

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).

Key facts

Study ID

NCT01185288

Run by

AbbVie (prior sponsor, Abbott)

People needed

309

Starts

2010-09-01

Expected to finish

2013-01-01

Last updated by the study team

2014-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects with moderately to severely active rheumatoid arthritis
• Subjects must have a DAS28(CRP) (Disease Activity Score using C-Reactive Protein) greater than or equal to 3.2 at baseline (there is no minimum CRP score required to qualify)
• Subjects must have at least 5/68 tender joints plus 5/66 swollen joints assessed at screening or baseline
• Subject must treated with and MTX (methotrexate) dose (oral and/or injectable) of 15 mg or more per week (no upper limit on dose) for at least 12 weeks prior to screening
• Subject is either biologic-naïve or has only one prior biologic disease-modifying antirheumatic drug (i.e. abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, or tocilizumab)

You may not qualify if…

• Previous exposure to adalimumab (Humira), rituximab (Rituxan), natalizumab (Tysabri), efalizumab (Raptiva)
• Subject has been treated with intra-articular or parenteral administration of corticosteroids within 4 weeks of screening
• Subject has diagnosis or history of gout or pseudogout
• Subject has undergone joint surgery within 12 weeks of screening (at joints to be assessed by ultrasound)
• Subject has history of chronic arthritis diagnosed before age 16 years

Where it is running

• Site Reference ID/Investigator# 38982 — Huntsville, Alabama, United States
• Site Reference ID/Investigator# 38686 — Tuscaloosa, Alabama, United States
• Site Reference ID/Investigator# 42044 — Mesa, Arizona, United States
• Site Reference ID/Investigator# 37983 — Phoenix, Arizona, United States
• Site Reference ID/Investigator# 44823 — Little Rock, Arkansas, United States
• Site Reference ID/Investigator# 37981 — Hemet, California, United States
• Site Reference ID/Investigator# 40208 — Long Beach, California, United States
• Site Reference ID/Investigator# 38423 — Sacramento, California, United States
• Site Reference ID/Investigator# 38204 — Victorville, California, United States
• Site Reference ID/Investigator# 40762 — Walnut Creek, California, United States
• Site Reference ID/Investigator# 43049 — Danbury, Connecticut, United States
• Site Reference ID/Investigator# 38687 — Jacksonville, Florida, United States
• Site Reference ID/Investigator# 40105 — Miami, Florida, United States
• Site Reference ID/Investigator# 38083 — Sarasota, Florida, United States
• Site Reference ID/Investigator# 38688 — Lawrenceville, Georgia, United States
• Site Reference ID/Investigator# 38689 — Meridian, Idaho, United States
• Site Reference ID/Investigator# 38085 — Rock Island, Illinois, United States
• Site Reference ID/Investigator# 40128 — Springfield, Illinois, United States
• Site Reference ID/Investigator# 38981 — Bowling Green, Kentucky, United States
• Site Reference ID/Investigator# 38086 — Covington, Louisiana, United States
• Site Reference ID/Investigator# 40125 — Fall River, Massachusetts, United States
• Site Reference ID/Investigator# 65490 — Las Vegas, Nevada, United States
• Site Reference ID/Investigator# 40124 — Clifton, New Jersey, United States
• Site Reference ID/Investigator# 38978 — Freehold, New Jersey, United States
• Site Reference ID/Investigator# 40123 — Voorhees Township, New Jersey, United States

Full record on ClinicalTrials.gov

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