Utlizing the RA signature to predict response to TNFi

Inclusion Criteria
Subjects who meet all of the following criteria at screening are eligible for enrollment into the study:
Written informed consent signed by the subject;
Fulfill ACR/EULAR 2010 criteria for RA;
Men ≥ 45 years and women ≥ 50 years;
MTX monotherapy for ≥ 8 weeks at ≥ 15mg weekly or on at least 7.5mg of methotrexate weekly for ≥8 weeks with a documented intolerance of higher MTX doses, and on a stable dose for the previous 4 weeks;
DAS28 score > 3.2;
Males and females with reproductive potential must agree to practice effective measures of birth control;
If taking prednisone (or equivalent corticosteroid), the dose must be ≤ 10 mg/day at the time of the baseline If taking a low-dose statin, the dose must be stable for six weeks prior to screening and must not change during the six months of the trial (please see Statins and PCSK9 Inhibitors Section 4.4.2 for further details);
Willing to comply with all study procedures and be available for the duration of the study;
Rheumatoid arthritis diagnosis without psoriasis or with psoriasis if rheumatoid factor ≥ 2x ULN or anti-CCP ≥ 2x ULN.
Exclusion Criteria
Prior use of biologic DMARD or small molecule DMARD (i.e. tofacitinib) in the past 6 months, use of Rituximab ever;
If a subject is considered to be an etanercept (Enbrel) or adalimumab (Humira) failure by their primary rheumatologist;
Non-biologic DMARDs other than MTX for two months prior to Screening;
Current use, or use within the past 12 months, of a moderate or high dose statin lipid lowering drug or a PCSK9 inhibitor (alirocumab/Praluent, Evolocumab/Repatha, or Bococizumab);
Prior patient reported, physician diagnosed clinical CV event: myocardial infarction or heart attack, angina, stroke, uncompensated or severe heart failure (NYHA class III or IV), prior vascular procedure (coronary artery angioplasty or stenting, carotid endarterectomy, coronary artery bypass surgery);
Demyelinating disease;
Any of the following forms of arthritis that may otherwise explain the subject’s RA symptoms: Psoriatic Arthritis, Reactive Arthritis, Juvenile Idiopathic Arthritis, Ankylosing Spondylitis, Polymyalgia Rheumatica
Any of the following other autoimmune and/or chronic inflammatory diseases: Inflammatory Bowel Disease, Crohn’s disease, Cutaneous or Systemic Lupus, Systemic Vasculitis, Giant Cell Arteritis, Polymyositis, Dermatomyositis, Sarcoidosis, or Scleroderma;
Transient ischemic attack (TIA);
Revascularization for peripheral artery disease;
Cancer treated in last five years (except basal and squamous cell) or any lymphoma or melanoma; Type I diabetes mellitus or type II diabetes mellitus treated with insulin or uncontrolled with HbA1c ≥7%;
Known pregnancy, HIV, hepatitis B, hepatitis C, active (or untreated latent) TB;
Known sulfa allergy or other known hypersensitivity to any of the trial agents or G6PD deficiency;
Known macular disease or known retinal disease;
Baseline blood count, renal or liver abnormalities as follows: WBC < 3.5 x 1000 n/ul, Hematocrit < 30%, Platelet count < 90 x 1,000 n/ul, estimated glomerular filtration rate < 50 ml/min/1.7m2, AST >60 U/L, ALT>84 U/L;Two or more of the following high dose radiation scans in the past year: CT scan with contrast, angiogram, SPECT nuclear medicine scan, myocardial (cardiac) perfusion scan.
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