Treatments Against RA and Effect on FDG-PET/CT
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate; Sulfasalazine; Hydroxychloroquine; Etanercept; Adalimumab
Intervention description: 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.; 1 gm bid; 200 mg twice daily, not to exceed 6.5mg/kg; 50 mg SC weekly; 40 mg SQ every other week
Intervention MeSH terms: Hydroxychloroquine; Sulfasalazine; Adalimumab; Etanercept; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 159.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: rheumatoid arthritis

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).
    

Eligibility 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)