To be eligible for the study, patients must meet the following criteria at their first study visit:
- have a diagnosis of Rheumatoid Arthritis.
- men must be 45 or older, and women 50 or older
- be taking at least 15mg of methotrexate weekly (or at least 7.5mg weekly with a documented intolerance of higher doses) for 2 months with no other RA medications.
- have moderate disease activity (DAS28 score > 3.2)
- be able to swallow pills at randomization
- agree to practice effective measures of birth control if of reproductive potential
- be willing to comply with all study procedures and be available for the duration of the study
Subjects must sign a form agreeing to participate in the trial and acknowledging that they understand what participation involves.
To be eligible, patients cannot have any of the following conditions:
Other autoimmune diseases:
Two or more of the following within the past year:
To be eligible, patients cannot take any of the following medications:
- Rituximab (Rituxan)
- A moderate- or high-intensity statin lipid lowering drug
- A PCSK9 inhibitor (alirocumab/Praluent, Evolocumab/Repatha, or Bococizumab)
- A biologic DMARD other than rituximab
- Tofacitinib (Xeljanz)
- Non-biologic DMARDs other than methotrexate or hydroxychloroquine (Plaquenil) for two months prior to Screening;
- More than 10mg per day of prednisone or
- A predinsone or other oral steroid taper