Treatments Against RA and Effect on FDG-PET/CT

• Status: Active, not recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Columbia University
• Treatments: Adalimumab; Etanercept; Hydroxychloroquine; Methotrexate; Sulfasalazine

Criteria

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)