Treatments Against RA and Effect on FDG-PET/CT



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:45 - Any
Updated:2/13/2019
Start Date:July 2016
End Date:March 2022
Contact:Daniel H Solomon
Email:dsolomon@partners.org

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Treatments Against RA and Effect on FDG-PET/CT (The TARGET Trial)

In a randomized controlled clinical trial, investigators will compare the effects on
[18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from
two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate
responders (MTX-IRs). Two common RA treatments will be compared: triple therapy
(sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF)
inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and
hydroxychloroquine for subjects who were taking this at screening).

Consenting subjects will be screened for eligibility and randomized to a treatment arm.
Subjects will be randomized to a treatment arm with either synthetic disease-modifying
antirheumatic drugs (DMARDs) [triple therapy: sulfasalazine, methotrexate, and
hydroxychloroquine] or biologic DMARDs [etanercept or adalimumab, plus background
methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at
screening].

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.

Inclusion Criteria:

- Fulfill American College of Rheumatology/European League Against Rheumatism 2010
criteria for RA

- 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:

- Use of biologic DMARD within the past 6 months or use of rituximab ever

- 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)
We found this trial at
34
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630 W 168th St
New York, New York
212-305-2862
Phone: 212-342-2713
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Jeffrey Curtis, MD
Phone: 205-934-9843
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Elena Massarotti, MD
Phone: 617-525-8786
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Marcy Bolster, MD
Phone: 617-643-5691
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
Principal Investigator: Ellen Ginzler, MD
Phone: 718-270-1190
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Rumey Ishizawar, MD
Phone: 919-966-0545
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Elaine Husni, MD
Phone: 216-444-4887
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Binh Nguyen, MD
Phone: 713-500-6852
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Cong-Qui Chu, MD
Phone: 503-494-5571
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Elena Schiopu, MD
Phone: 734-998-1271
University of Michigan The University of Michigan was founded in 1817 as one of the...
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Principal Investigator: Barbara Mendez, MD
Phone: 718-918-6212
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Eric Ruderman, MD
Phone: 312-503-1137
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Clearwater, Florida 33765
Principal Investigator: Robert W Levin, MD
Phone: 727-734-6631
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3505 Gaston Avenue
Dallas, Texas 75246
Principal Investigator: John Cush, MD
Phone: 214-820-9626
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Dallas, Texas 75231
Principal Investigator: Margarita Fallena, MD
Phone: 214-879-6737
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Duncansville, Pennsylvania 16635
Principal Investigator: Alan Kivitz, MD
Phone: 814-296-6101
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Great Neck, New York 11021
Principal Investigator: Diane Horowitz, MD
Phone: 516-708-2556
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: William FC Rigby, MD
Phone: 603-650-4717
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Kristine M Lohr, MD
Phone: 859-323-2093
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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10833 Le Conte Ave
Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Christina Charles, MD
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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Madison, Wisconsin 53706
(608) 263-2400
Principal Investigator: Karen Hansen, MD
Phone: 608-262-8317
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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Murrieta, California 92563
Principal Investigator: Brigid Freyne, MD
Phone: 951-696-4600
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1 Gustave L. Levy Place
New York, New York 10029
Principal Investigator: Yousaf Ali, MD
Phone: 212-241-4824
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Jose Scher, MD
Phone: 646-577-3555
New York University School of Medicine NYU School of Medicine has a proud history that...
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Palm Desert, California 92260
Principal Investigator: Maria Greenwald, MD
Phone: 760-341-6800
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Joshua Baker, MD
Phone: 215-662-6335
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Larry Moreland, MD
Phone: 412-647-2638
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Saint Louis, Missouri 63110
Principal Investigator: Deborah Parks, MD
Phone: 314-362-7306
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San Francisco, California 94143
Principal Investigator: Jonathan Graf, MD
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Seattle, Washington 98104
Principal Investigator: Philip Mease, MD
Phone: 206-386-2007
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Tampa, Florida 33609
Principal Investigator: Jeffrey Miller, MD
Phone: 813-879-1188
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Temple, Texas 76508
Principal Investigator: Beth Scholz, MD
Phone: 254-724-7727
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23101 Sherman Place
West Hills, California 91307
Principal Investigator: Nazanin Firooz, MD
Phone: 818-598-0000
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Wheaton, Maryland 20902
Principal Investigator: Alan K Matsumoto, MD
Phone: 301-942-6610
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