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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)

NCT01185288•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (49)

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

Key Dates

Start Date

September 1, 2010

Primary Completion Date

January 1, 2013

Completion Date

January 1, 2013

Last Updated

March 18, 2014

Enrollment

309

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

Adalimumab

BIOLOGICAL

Methotrexate

DRUG

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITING

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

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