Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
159 participants
INTERVENTIONAL
2016-07-31
2021-05-31
Brief Summary
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Detailed Description
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Once randomized, a baseline visit will be conducted with each subject. Baseline data collection includes questionnaires, disease activity score, and the first FDG-PET/CT imaging. After the baseline at week 0, subjects will visit with their rheumatologist at weeks 6, 12, 18, and 24 for safety labs and further collection of disease activity scores and questionnaires. The second FDG-PET/CT will be performed at week 24. Blood specimens will be collected at weeks 0, 6, 18, and 24 for bioassays. Subject participation will end after the week 24 visit.
Patients and care providers will be unblinded. The FDG-PET/CT image readers will be blinded to treatment arm as well as timepoint of image acquisition.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Triple therapy (MTX+SSZ+HCQ)
Sulfasalazine (SSZ) 1 g bid and hydroxychloroquine (HCQ) 200 mg twice daily, not to exceed 6.5mg/kg HCQ (in addition to concomitant methotrexate \[MTX\]).
Methotrexate
Subjects entering trial will continue on MTX dose of at least 15mg MTX/week. At the discretion of the treating rheumatologist, may be switched to SQ route.
Sulfasalazine
1 gm bid
Hydroxychloroquine
200 mg twice daily, not to exceed 6.5mg/kg
TNF inhibitor (etanercept or adalimumab)
etanercept 50 mg subcutaneously weekly or adalimumab 40 mg subcutaneously every other week (in addition to concomitant methotrexate, plus hydroxychloroquine, for subjects who were taking this at screening). Biologic treatment will be assigned randomly.
Methotrexate
Subjects entering trial will continue on MTX dose of at least 15mg MTX/week. At the discretion of the treating rheumatologist, may be switched to SQ route.
Etanercept
50 mg SC weekly
Adalimumab
40 mg SQ every other week
Interventions
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Methotrexate
Subjects entering trial will continue on MTX dose of at least 15mg MTX/week. At the discretion of the treating rheumatologist, may be switched to SQ route.
Sulfasalazine
1 gm bid
Hydroxychloroquine
200 mg twice daily, not to exceed 6.5mg/kg
Etanercept
50 mg SC weekly
Adalimumab
40 mg SQ every other week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men ≥ 45 years and women ≥ 50 years
* MTX monotherapy for ≥ 8 weeks at ≥ 15mg weekly or ≥ 7.5 mg weekly with a documented intolerance to higher doses
* No non-biologic DMARDs in preceding two months (other than MTX and HCQ)
* Disease Activity Score-28 \> 3.2
* Able to sign informed consent
Exclusion Criteria
* Current use of \>10mg per day of prednisone
* Use of a high-intensity statin lipid lowering drug or PCSK9 inhibitor in the past 12 months
* Prior patient reported, physician diagnosed clinical cardiovascular (CV) event
* Insulin-dependent or uncontrolled diabetes mellitus (DM)
* Systemic lupus erythematosus (SLE) or other autoimmune and chronic inflammatory diseases (i.e. inflammatory bowel disease, sarcoidosis)
* Cancer treated in the last 5 years (except basal and squamous cell) or any lymphoma or melanoma
* Known pregnancy, HIV, Hepatitis B Virus, Hepatitis C Virus, active (or untreated latent) tuberculosis
* Baseline: liver, renal or blood count abnormalities, Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Known sulfa allergy, macular disease or hypersensitivity to treatments; known demyelinating disease; uncompensated Congestive Heart Failure (CHF)
* Intra-articular injection within the 4 weeks prior to baseline FDG PET/CT
* 2 or more high dose radiation scans in the past year (CT scan with contrast, angiogram, SPECT nuclear medicine scan, myocardial/cardiac perfusion scan)
45 Years
ALL
No
Sponsors
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Columbia University
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Daniel H. Solomon, M.D.,MPH
Chief, Section of Clinical Sciences
Principal Investigators
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Daniel Solomon
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Loma Linda University Clinical Trial Center
Loma Linda, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Brigid Freyne, MD Inc.
Murrieta, California, United States
Desert Medical Advances
Palm Desert, California, United States
University of California San Francisco
San Francisco, California, United States
Nazanin Firooz MD, Inc.
West Hills, California, United States
Robert W. Levin, MD, PA
Clearwater, Florida, United States
IRIS Research and Development
Plantation, Florida, United States
Southwest Florida Clinical Research Center
Tampa, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University Medical Center
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Northwell Health
Great Neck, New York, United States
New York University School of Medicine
New York, New York, United States
Mount Sinai- Icahn School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Altoona Research Center
Duncansville, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Baylor Scott & White Medical Center- Temple
Temple, Texas, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Countries
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References
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Liao KP, Rist P, Giles J, Santacroce L, Connelly MA, Glynn RJ, Ridker P, Tawakol A, Bathon J, Solomon DH. Impact of RA treatment strategies on lipids and vascular inflammation in rheumatoid arthritis: a secondary analysis of the TARGET randomized active comparator trial. Arthritis Res Ther. 2024 Jun 24;26(1):123. doi: 10.1186/s13075-024-03352-3.
Solomon DH, Giles JT, Liao KP, Ridker PM, Rist PM, Glynn RJ, Broderick R, Lu F, Murray MT, Vanni K, Santacroce LM, Abohashem S, Robson PM, Fayad Z, Mani V, Tawakol A, Bathon J; TARGET Trial Consortium. Reducing cardiovascular risk with immunomodulators: a randomised active comparator trial among patients with rheumatoid arthritis. Ann Rheum Dis. 2023 Mar;82(3):324-330. doi: 10.1136/ard-2022-223302. Epub 2022 Nov 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014P002747
Identifier Type: -
Identifier Source: org_study_id
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