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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)

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Adalimumab (Biological); Methotrexate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Dawn Carlson, MD, Study Director, Affiliation: AbbVie

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).

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

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

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

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Site Reference ID/Investigator# 38691, San Juan 00936-8344, Puerto Rico

Site Reference ID/Investigator# 60850, San Juan 00936-5067, Puerto Rico

Site Reference ID/Investigator# 60851, Vega Baja 00694-0764, Puerto Rico

Site Reference ID/Investigator# 38982, Huntsville, Alabama 35801, United States

Site Reference ID/Investigator# 38686, Tuscaloosa, Alabama 35406, United States

Site Reference ID/Investigator# 42044, Mesa, Arizona 85202, United States

Site Reference ID/Investigator# 37983, Phoenix, Arizona 85031, United States

Site Reference ID/Investigator# 44823, Little Rock, Arkansas 72205, United States

Site Reference ID/Investigator# 37981, Hemet, California 92543, United States

Site Reference ID/Investigator# 40208, Long Beach, California 90822, United States

Site Reference ID/Investigator# 38423, Sacramento, California 95816, United States

Site Reference ID/Investigator# 38204, Victorville, California 92395, United States

Site Reference ID/Investigator# 40762, Walnut Creek, California 94598, United States

Site Reference ID/Investigator# 43049, Danbury, Connecticut 06810, United States

Site Reference ID/Investigator# 38687, Jacksonville, Florida 32209, United States

Site Reference ID/Investigator# 40105, Miami, Florida 33169, United States

Site Reference ID/Investigator# 38083, Sarasota, Florida 34239, United States

Site Reference ID/Investigator# 38688, Lawrenceville, Georgia 30045, United States

Site Reference ID/Investigator# 38689, Meridian, Idaho 83642, United States

Site Reference ID/Investigator# 38085, Rock Island, Illinois 61201, United States

Site Reference ID/Investigator# 40128, Springfield, Illinois 62704, United States

Site Reference ID/Investigator# 38981, Bowling Green, Kentucky 42101, United States

Site Reference ID/Investigator# 38086, Covington, Louisiana 70433, United States

Site Reference ID/Investigator# 40125, Fall River, Massachusetts 02720, United States

Site Reference ID/Investigator# 65490, Las Vegas, Nevada 89102, United States

Site Reference ID/Investigator# 40124, Clifton, New Jersey 07012, United States

Site Reference ID/Investigator# 38978, Freehold, New Jersey 07728, United States

Site Reference ID/Investigator# 40123, Voorhees, New Jersey 08043, United States

Site Reference ID/Investigator# 38983, Bronx, New York 10467, United States

Site Reference ID/Investigator# 38264, Smithtown, New York 11787, United States

Site Reference ID/Investigator# 38263, Asheville, North Carolina 28803, United States

Site Reference ID/Investigator# 38261, Greenville, North Carolina 27834, United States

Site Reference ID/Investigator# 39024, Mayfield Village, Ohio 44143, United States

Site Reference ID/Investigator# 40127, Oklahoma City, Oklahoma 73104, United States

Site Reference ID/Investigator# 38202, Bend, Oregon 97701, United States

Site Reference ID/Investigator# 39023, Eugene, Oregon 97401, United States

Site Reference ID/Investigator# 38265, Duncansville, Pennsylvania 16635, United States

Site Reference ID/Investigator# 38082, Jackson, Tennessee 38305, United States

Site Reference ID/Investigator# 37980, Dallas, Texas 75231, United States

Site Reference ID/Investigator# 44888, Dallas, Texas 75246, United States

Site Reference ID/Investigator# 43050, Houston, Texas 77074, United States

Site Reference ID/Investigator# 43735, San Antonio, Texas 78229, United States

Site Reference ID/Investigator# 44344, Richmond, Virginia 23294, United States

Site Reference ID/Investigator# 38084, Seattle, Washington 98122, United States

Site Reference ID/Investigator# 38542, Seattle, Washington 98133, United States

Site Reference ID/Investigator# 40210, Seattle, Washington 98101, United States

Site Reference ID/Investigator# 38424, Spokane, Washington 99204, United States

Site Reference ID/Investigator# 38203, Tacoma, Washington 98405, United States

Site Reference ID/Investigator# 38087, Franklin, Wisconsin 53132, United States

Additional Information

Starting date: September 2010
Last updated: January 31, 2014

Page last updated: August 23, 2015

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