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)

AbbVie

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Biological: Adalimumab; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01185288

M12-071

Details and patient eligibility

About

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).

Enrollment: 309 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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309 participants in 2 patient groups

Adalimumab + Low Dose Methotrexate

Experimental group

Description:

Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).

Treatment:

Drug: Methotrexate

Biological: Adalimumab

Adalimumab + High Dose Methotrexate

Active Comparator group

Description:

Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).

Treatment:

Drug: Methotrexate

Biological: Adalimumab