TARGET Trial Study Cohort

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. ]]>
TARGET Trial Research Consent Form (UW-Madison)Partners HealthCare System Research Consent Form (BSWRI)Adverse Event FormPartners HealthCare System Research Consent Form (DHMC)Partners HealthCare System Research Consent Form (UPMC)Partners HealthCare System Research Consent Form (Northwestern)Partners HealthCare System Research Consent Form (SUNY Downstate)Partners HealthCare System Research Consent FormFollow-Up FDG-PET/CT FormHomonculusMedication UpdateProtocol Deviation FormSurvey - Incidental FindingsHealth and LifePre-Screen ChecklistTreatments Against RA and Effect on FDG PET-CT: The TARGET TrialHealth and Life (Spanish)V1 ScreeningV2 Baseline VisitV3V4V5V6WithdrawalInclusion 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) ]]>
The TARGET trial was funded and enrollment completed in 2022. Data cleaning and publication of the main study findings occurred during 2023. Other secondary publications have been published or submitted in 2024. We continue to work with the data on further analyses through a follow on grant. We are now ready to deposit a cleaned database for public use by qualified researchers.]]>