Status:
COMPLETED
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)
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 o...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT01185288
Start Date
September 1 2010
End Date
January 1 2013
Last Update
March 18 2014
Active Locations (49)
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1
Site Reference ID/Investigator# 38982
Huntsville, Alabama, United States, 35801
2
Site Reference ID/Investigator# 38686
Tuscaloosa, Alabama, United States, 35406
3
Site Reference ID/Investigator# 42044
Mesa, Arizona, United States, 85202
4
Site Reference ID/Investigator# 37983
Phoenix, Arizona, United States, 85031