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Rheumatoid ArthritisPhase 4MUSICANCT01185288

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 Phase 4 study testing Adalimumab and Methotrexate in people with Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 49 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Adalimumab and Methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
309 participants
Where
49 sitesin 2 countries
Study dates
Sep 2010to Jan 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

49 sites in 2 countries.

49 sites in 2 countries

United States46 sites

  • Site Reference ID/Investigator# 38263

    Asheville, North Carolina, 28803

  • Site Reference ID/Investigator# 38202

    Bend, Oregon, 97701

  • Site Reference ID/Investigator# 38981

    Bowling Green, Kentucky, 42101

  • Site Reference ID/Investigator# 40124

    Clifton, New Jersey, 07012

  • Site Reference ID/Investigator# 38086

    Covington, Louisiana, 70433

  • Site Reference ID/Investigator# 37980

    Dallas, Texas, 75231

  • Site Reference ID/Investigator# 44888

    Dallas, Texas, 75246

  • Site Reference ID/Investigator# 43049

    Danbury, Connecticut, 06810

  • Site Reference ID/Investigator# 38265

    Duncansville, Pennsylvania, 16635

  • Site Reference ID/Investigator# 39023

    Eugene, Oregon, 97401

  • Site Reference ID/Investigator# 40125

    Fall River, Massachusetts, 02720

  • Site Reference ID/Investigator# 38087

    Franklin, Wisconsin, 53132

  • Site Reference ID/Investigator# 38978

    Freehold, New Jersey, 07728

  • Site Reference ID/Investigator# 38261

    Greenville, North Carolina, 27834

  • Site Reference ID/Investigator# 37981

    Hemet, California, 92543

  • Site Reference ID/Investigator# 43050

    Houston, Texas, 77074

  • Site Reference ID/Investigator# 38982

    Huntsville, Alabama, 35801

  • Site Reference ID/Investigator# 38082

    Jackson, Tennessee, 38305

  • Site Reference ID/Investigator# 38687

    Jacksonville, Florida, 32209

  • Site Reference ID/Investigator# 65490

    Las Vegas, Nevada, 89102

  • Site Reference ID/Investigator# 38688

    Lawrenceville, Georgia, 30045

  • Site Reference ID/Investigator# 44823

    Little Rock, Arkansas, 72205

  • Site Reference ID/Investigator# 40208

    Long Beach, California, 90822

  • Site Reference ID/Investigator# 39024

    Mayfield Village, Ohio, 44143

  • Site Reference ID/Investigator# 38689

    Meridian, Idaho, 83642

  • Site Reference ID/Investigator# 42044

    Mesa, Arizona, 85202

  • Site Reference ID/Investigator# 40105

    Miami, Florida, 33169

  • Site Reference ID/Investigator# 40127

    Oklahoma City, Oklahoma, 73104

  • Site Reference ID/Investigator# 37983

    Phoenix, Arizona, 85031

  • Site Reference ID/Investigator# 44344

    Richmond, Virginia, 23294

  • Site Reference ID/Investigator# 38085

    Rock Island, Illinois, 61201

  • Site Reference ID/Investigator# 38423

    Sacramento, California, 95816

  • Site Reference ID/Investigator# 43735

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 38083

    Sarasota, Florida, 34239

  • Site Reference ID/Investigator# 40210

    Seattle, Washington, 98101

  • Site Reference ID/Investigator# 38084

    Seattle, Washington, 98122

  • Site Reference ID/Investigator# 38542

    Seattle, Washington, 98133

  • Site Reference ID/Investigator# 38264

    Smithtown, New York, 11787

  • Site Reference ID/Investigator# 38424

    Spokane, Washington, 99204

  • Site Reference ID/Investigator# 40128

    Springfield, Illinois, 62704

  • Site Reference ID/Investigator# 38203

    Tacoma, Washington, 98405

  • Site Reference ID/Investigator# 38983

    The Bronx, New York, 10467

  • Site Reference ID/Investigator# 38686

    Tuscaloosa, Alabama, 35406

  • Site Reference ID/Investigator# 38204

    Victorville, California, 92395

  • Site Reference ID/Investigator# 40123

    Voorhees Township, New Jersey, 08043

  • Site Reference ID/Investigator# 40762

    Walnut Creek, California, 94598

Other trials in United States

Puerto Rico3 sites

  • Site Reference ID/Investigator# 60850

    San Juan, 00936-5067

  • Site Reference ID/Investigator# 38691

    San Juan, 00936-8344

  • Site Reference ID/Investigator# 60851

    Vega Baja, 00694-0764

Other trials in Puerto Rico

About this study

Official title: 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)

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).

Keywords
Rheumatoid Arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdalimumabBiological

    Also called ABT-D2E7, Humira

    Adalimumab in pre-filled syringes

  • MethotrexateDrug

    Methotrexate capsule

Study groups in NCT01185288
Study groupRoleWhat they receive
Adalimumab + Low Dose MethotrexateExperimentalOpen-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
Receives: Biological: Adalimumab; Drug: Methotrexate
Adalimumab + High Dose MethotrexateActive comparatorOpen-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
Receives: Biological: Adalimumab; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Activity Score for 28 Joints Based on C-reactive Protein (DAS28[CRP]) at Week 24

    The DAS28(CRP) score includes 28 tender joint counts, 28 swollen joint counts, C-reactive protein, and participant's global assessment of disease activity. Scores on the DAS28(CRP) range from 0 to 10. A DAS28(CRP) score ≥ 5.1 indicates high disease activity, and a DAS28(CRP) score < 2.6 indicates clinical remission. Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline DAS28(CRP) value, treatment group, and prior methotrexate dose group.

    Measured: Week 24

Secondary outcomes (5)

  1. Percentage of Participants With Power Doppler Ultrasound (PD U/S) Score for Synovial Vascularity Improvement by 30% at Week 24

    PD U/S assessed the severity of synovial inflammation in both hands (bilateral wrists, metacarpophalangeal joints 2, 3, 5, and metatarsophalangeal joint 5). Bilateral images based on dorsal midline imaging of the wrist, dorsal and volar imaging of metacarpophalangeal joints, and dorsal imaging alone of metatarsophalangeal joints are scored using a 4-grade scale: grade 0 or normal = normal joint (no Doppler signal); grade 1 or mild = mild synovitis (≤ 3 isolated signals); grade 2 or moderate = moderate synovitis (> 3 isolated signals or a confluent signal in < 50% of synovial area); grade 3 or marked = marked synovitis (signals in ≥ 50% of the synovial area). Each image is rated 0 to 3, for a total possible score ranging from 0 to 48 (16*0, 16*3) for 2 hands. Higher grade/score=more severe disease. Change = week 24 score - baseline score.

    Measured: Baseline, 24 weeks

  2. Percentage of Participants With American College of Rheumatology 50% (ACR50) Criteria Response at Week 24

    Response, as defined by ACR50 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).

    Measured: Baseline, 24 weeks

  3. Percentage of Participants With American College of Rheumatology 70% (ACR70) Criteria Response at Week 24

    Response, as defined by ACR70 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).

    Measured: Baseline, 24 weeks

  4. Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤ -0.22 at Week 24

    The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high dependency disability). The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from baseline of ≤ -0.22. Normal physical function is defined by HAQ-DI score of < 0.5. Negative change from baseline in the overall score indicates improvement.

    Measured: Baseline, 24 weeks

  5. Percent Change From Baseline in Medical Outcomes Study Version II (MOS) Sleep Problem Index 9 at Week 24

    The least squares mean percentage change in MOS Sleep Problem Index 9 from baseline to week 24. The MOS Sleep Problem Index 9 consists of 9 questions to assess sleep, including how long it takes the participant to fall asleep (1=0 to 15 minutes, to 5=more than 60 minutes); and aspects of related to quality of sleep, including how often the participant felt that the sleep was not quiet, felt rested upon waking, awakened short of breath or with a headache, felt drowsy during the day, had trouble falling sleep, how often were awaken, had trouble staying awake during the day, and got needed amount of sleep (1=all the time; 5=none of the time). Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline MOS Sleep Problem Index value, treatment group, and prior methotrexate dose group.

    Measured: Baseline, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01185288
Sponsor's protocol ID
M12-071
Acronym
MUSICA
Status last verified
Jan 2014
First submitted
18 Aug 2010
Last updated
18 Mar 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 30173153

  • 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.

    PubMed 29574622

  • 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.

    PubMed 28955494

  • 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.

    PubMed 27338778

  • 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.

    PubMed 27307526

  • 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.

    PubMed 27214046

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adalimumab and Methotrexate in people with Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 49 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Activity Score for 28 Joints Based on C-reactive Protein (DAS28[CRP]) at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01185288, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.

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