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)
NCT ID: NCT01185288
Last Updated: 2014-03-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
309 participants
INTERVENTIONAL
2010-09-30
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)
NCT01185301
Methotrexate-Inadequate Response Study
NCT00559585
Remission and Joint Damage Progression in Early Rheumatoid Arthritis
NCT00122382
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.
NCT00195702
A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate
NCT04909801
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adalimumab + Low Dose Methotrexate
Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
Adalimumab
Adalimumab in pre-filled syringes
Methotrexate
Methotrexate capsule
Adalimumab + High Dose Methotrexate
Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
Adalimumab
Adalimumab in pre-filled syringes
Methotrexate
Methotrexate capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Adalimumab
Adalimumab in pre-filled syringes
Methotrexate
Methotrexate capsule
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dawn Carlson, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Site Reference ID/Investigator# 38264
Smithtown, New York, United States
Site Reference ID/Investigator# 38983
The Bronx, New York, United States
Site Reference ID/Investigator# 38263
Asheville, North Carolina, United States
Site Reference ID/Investigator# 38261
Greenville, North Carolina, United States
Site Reference ID/Investigator# 39024
Mayfield Village, Ohio, United States
Site Reference ID/Investigator# 40127
Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 38202
Bend, Oregon, United States
Site Reference ID/Investigator# 39023
Eugene, Oregon, United States
Site Reference ID/Investigator# 38265
Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 38082
Jackson, Tennessee, United States
Site Reference ID/Investigator# 37980
Dallas, Texas, United States
Site Reference ID/Investigator# 44888
Dallas, Texas, United States
Site Reference ID/Investigator# 43050
Houston, Texas, United States
Site Reference ID/Investigator# 43735
San Antonio, Texas, United States
Site Reference ID/Investigator# 44344
Richmond, Virginia, United States
Site Reference ID/Investigator# 40210
Seattle, Washington, United States
Site Reference ID/Investigator# 38084
Seattle, Washington, United States
Site Reference ID/Investigator# 38542
Seattle, Washington, United States
Site Reference ID/Investigator# 38424
Spokane, Washington, United States
Site Reference ID/Investigator# 38203
Tacoma, Washington, United States
Site Reference ID/Investigator# 38087
Franklin, Wisconsin, United States
Site Reference ID/Investigator# 60850
San Juan, , Puerto Rico
Site Reference ID/Investigator# 38691
San Juan, , Puerto Rico
Site Reference ID/Investigator# 60851
Vega Baja, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kaeley GS, MacCarter DK, Pangan AL, Wang X, Kalabic J, Ranganath VK. Clinical Responses and Synovial Vascularity in Obese Rheumatoid Arthritis Patients Treated with Adalimumab and Methotrexate. J Rheumatol. 2018 Dec;45(12):1628-1635. doi: 10.3899/jrheum.171232. Epub 2018 Sep 1.
Kaeley GS, MacCarter DK, Goyal JR, Liu S, Chen K, Griffith J, Kupper H, Garg V, Kalabic J. Similar Improvements in Patient-Reported Outcomes Among Rheumatoid Arthritis Patients Treated with Two Different Doses of Methotrexate in Combination with Adalimumab: Results From the MUSICA Trial. Rheumatol Ther. 2018 Jun;5(1):123-134. doi: 10.1007/s40744-018-0105-7. Epub 2018 Mar 24.
Burmester GR, Kaeley GS, Kavanaugh AF, Gabay C, MacCarter DK, Nash P, Takeuchi T, Goss SL, Rodila R, Chen K, Kupper H, Kalabic J. Treatment efficacy and methotrexate-related toxicity in patients with rheumatoid arthritis receiving methotrexate in combination with adalimumab. RMD Open. 2017 Sep 17;3(2):e000465. doi: 10.1136/rmdopen-2017-000465. eCollection 2017.
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Kaeley GS, Evangelisto AM, Nishio MJ, Goss SL, Liu S, Kalabic J, Kupper H. Methotrexate Dosage Reduction Upon Adalimumab Initiation: Clinical and Ultrasonographic Outcomes from the Randomized Noninferiority MUSICA Trial. J Rheumatol. 2016 Aug;43(8):1480-9. doi: 10.3899/jrheum.151009. Epub 2016 Jun 15.
Kaeley GS, Nishio MJ, Goyal JR, MacCarter DK, Wells AF, Chen S, Kupper H, Kalabic J. Changes in Ultrasonographic Vascularity Upon Initiation of Adalimumab Combination Therapy in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2016 Nov;68(11):2584-2592. doi: 10.1002/art.39751. Epub 2016 Sep 29.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M12-071
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.