Phase 4
Completed N=309
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)
Source: ClinicalTrials.gov NCT01185288 ↗Enrolled (actual)
309
Serious AEs
5.5%
Results posted
Mar 2014
Primary outcomePrimary: Disease Activity Score for 28 Joints Based on C-reactive Protein (DAS28[CRP]) at Week 24 — 4.11; 3.75 scores on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Activity Score for 28 Joints Based on C-reactive Protein (DAS28[CRP]) at Week 24 |
4.11; 3.75 | — |
| SECONDARY Percentage of Participants With Power Doppler Ultrasound (PD U/S) Score for Synovial Vascularity Improvement by 30% at Week 24 |
45.45; 52.38 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 50% (ACR50) Criteria Response at Week 24 |
29.80; 37.66 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 70% (ACR70) Criteria Response at Week 24 |
13.25; 20.13 | — |
| SECONDARY Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤ -0.22 at Week 24 |
63.58; 65.58 | — |
| SECONDARY Percent Change From Baseline in Medical Outcomes Study Version II (MOS) Sleep Problem Index 9 at Week 24 |
-15.42; -17.27 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01185288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.