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)
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01185288
First received: August 18, 2010
Last updated: March 6, 2013
Last verified: February 2013
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Purpose
This study will investigate the efficacy of both high and low doses of MTX in combination with open-label adalimumab 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 adalimumab in subjects with rheumatoid arthritis (RA).
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Biological: Humira (adalimumab) Drug: Methotrexate (MTX) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Non-inferiority of low dose MTX + adalimumab compared to high dose MTX + adalimumab, based on the Mean Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) score in each treatment Arm at Week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Ultrasound (U/S) disease activity Power Doppler (PD) Score [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- American College of Rheumatology (ACR) 50/70 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- Health Assessment Questionnaire-Disability Index (HAQ-DI) and Medical Outcomes Sleep (MOS) Index II [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 308 |
| Study Start Date: | September 2010 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
Adalimumab plus high dose methotrexate
|
Biological: Humira (adalimumab)
Open-label adalimumab 40 mg every other week
Other Name: ABT-D2E7
Drug: Methotrexate (MTX)
Blinded low dose oral MTX once per week or blinded high dose oral MTX once per week
|
|
Active Comparator: Arm 2
Adalimumab plus low dose methotrexate
|
Biological: Humira (adalimumab)
Open-label adalimumab 40 mg every other week
Other Name: ABT-D2E7
Drug: Methotrexate (MTX)
Blinded low dose oral MTX once per week or blinded high dose oral MTX once per week
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult subjects with moderately to severely activate rheumatoid arthritis
- Subjects must have a DAS28(CRP) (Disease Activity Score using C-Reactive Protein) greater than or equal to 3.2 at the Baseline Visit (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 15mg 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-DMARD (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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185288
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Hide Study LocationsLocations
| United States, Alabama | |
| Site Reference ID/Investigator# 38982 | |
| Huntsville, Alabama, United States, 35801 | |
| Site Reference ID/Investigator# 38686 | |
| Tuscaloosa, Alabama, United States, 35406 | |
| United States, Arizona | |
| Site Reference ID/Investigator# 42044 | |
| Mesa, Arizona, United States, 85202 | |
| Site Reference ID/Investigator# 37983 | |
| Paradise Valley, Arizona, United States, 85253 | |
| United States, Arkansas | |
| Site Reference ID/Investigator# 44823 | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Site Reference ID/Investigator# 37981 | |
| Hemet, California, United States, 92543 | |
| Site Reference ID/Investigator# 40208 | |
| Long Beach, California, United States, 90822 | |
| Site Reference ID/Investigator# 38423 | |
| Sacramento, California, United States, 95816 | |
| Site Reference ID/Investigator# 38204 | |
| Victorville, California, United States, 92395 | |
| Site Reference ID/Investigator# 40762 | |
| Walnut Creek, California, United States, 94598 | |
| United States, Connecticut | |
| Site Reference ID/Investigator# 43049 | |
| Danbury, Connecticut, United States, 06810 | |
| United States, Florida | |
| Site Reference ID/Investigator# 38687 | |
| Jacksonville, Florida, United States, 32209 | |
| Site Reference ID/Investigator# 40105 | |
| Miami, Florida, United States, 33169 | |
| Site Reference ID/Investigator# 38083 | |
| Sarasota, Florida, United States, 34239 | |
| United States, Georgia | |
| Site Reference ID/Investigator# 38688 | |
| Lawrenceville, Georgia, United States, 30045 | |
| United States, Idaho | |
| Site Reference ID/Investigator# 38689 | |
| Meridian, Idaho, United States, 83642 | |
| United States, Illinois | |
| Site Reference ID/Investigator# 38085 | |
| Rock Island, Illinois, United States, 61201 | |
| Site Reference ID/Investigator# 40128 | |
| Springfield, Illinois, United States, 62704 | |
| United States, Kentucky | |
| Site Reference ID/Investigator# 38981 | |
| Bowling Green, Kentucky, United States, 42101 | |
| United States, Louisiana | |
| Site Reference ID/Investigator# 38086 | |
| Covington, Louisiana, United States, 70433 | |
| United States, Massachusetts | |
| Site Reference ID/Investigator# 40125 | |
| Fall River, Massachusetts, United States, 02720 | |
| United States, Nevada | |
| Site Reference ID/Investigator# 65490 | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| Site Reference ID/Investigator# 40124 | |
| Clifton, New Jersey, United States, 07012 | |
| Site Reference ID/Investigator# 38978 | |
| Freehold, New Jersey, United States, 07728 | |
| Site Reference ID/Investigator# 40123 | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| Site Reference ID/Investigator# 38983 | |
| Bronx, New York, United States, 10467 | |
| Site Reference ID/Investigator# 38264 | |
| Smithtown, New York, United States, 11787 | |
| United States, North Carolina | |
| Site Reference ID/Investigator# 38263 | |
| Asheville, North Carolina, United States, 28803 | |
| Site Reference ID/Investigator# 38261 | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Ohio | |
| Site Reference ID/Investigator# 39024 | |
| Mayfield Village, Ohio, United States, 44143 | |
| United States, Oklahoma | |
| Site Reference ID/Investigator# 40127 | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Site Reference ID/Investigator# 38202 | |
| Bend, Oregon, United States, 97701 | |
| Site Reference ID/Investigator# 39023 | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Site Reference ID/Investigator# 38265 | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Tennessee | |
| Site Reference ID/Investigator# 38082 | |
| Jackson, Tennessee, United States, 38305 | |
| United States, Texas | |
| Site Reference ID/Investigator# 37980 | |
| Dallas, Texas, United States, 75231 | |
| Site Reference ID/Investigator# 44888 | |
| Dallas, Texas, United States, 75246 | |
| Site Reference ID/Investigator# 43050 | |
| Houston, Texas, United States, 77074 | |
| Site Reference ID/Investigator# 43735 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Site Reference ID/Investigator# 44344 | |
| Richmond, Virginia, United States, 23294 | |
| United States, Washington | |
| Site Reference ID/Investigator# 38084 | |
| Seattle, Washington, United States, 98104 | |
| Site Reference ID/Investigator# 40210 | |
| Seattle, Washington, United States, 98101 | |
| Site Reference ID/Investigator# 38542 | |
| Seattle, Washington, United States, 98133 | |
| Site Reference ID/Investigator# 38424 | |
| Spokane, Washington, United States, 99204 | |
| Site Reference ID/Investigator# 38203 | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Site Reference ID/Investigator# 38087 | |
| Franklin, Wisconsin, United States, 53132 | |
| Puerto Rico | |
| Site Reference ID/Investigator# 38691 | |
| San Juan, Puerto Rico, 00936-8344 | |
| Site Reference ID/Investigator# 60850 | |
| San Juan, Puerto Rico, 00936-5067 | |
| Site Reference ID/Investigator# 60851 | |
| Vega Baja, Puerto Rico, 00694-0764 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Dawn Carlson, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01185288 History of Changes |
| Other Study ID Numbers: | M12-071 |
| Study First Received: | August 18, 2010 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AbbVie:
|
Rheumatoid Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Adalimumab Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013