Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis

Inclusion Criteria:

• Diagnosis of RA as defined by 1987 American College of Rheumatology (ACR) criteria
• Functional Class I, II, or III RA as defined by 1987 ACR criteria
• Serum C-reactive protein (CRP) measurement of greater than 5 mg/L
• Mildly active disease with at least one swollen and two tender joints, but no morethan six swollen and eight tender joints
• If on corticosteroids, dose must be stable and 10 mg/day prednisone (or equivalent) orless for at least 4 weeks prior to study entry
• If on DMARD, dose must be stable for at least 4 weeks (methotrexate, leflunomide,azathioprine, etanercept, adalimumab, anakinra) or at least 3 months (hydroxychloroquine, gold, or abatacept)
• Willing to use acceptable means of contraception

Exclusion Criteria:

• Serum creatinine level greater than 1.5 mg/dL
• Currently taking a statin or have taken a statin within 12 weeks of study entry
• History of an adverse reaction to a statin
• Active or recent infection within 4 weeks of study entry
• Myositis or an unexplained elevation in creatine phosphokinase (CPK)
• Joint replacement surgery within 60 days of study entry or plan to undergo jointreplacement surgery during the course of the study
• Intra-articular cortisone injections within 4 weeks of study entry
• Chronic disorders other than RA affecting the joints, including systemic lupuserythematosus (SLE), psoriatic arthritis, gout, scleroderma, or known reactivearthritis (Reiter's syndrome)
• HIV infection
• Hepatitis B surface antigen positive
• Hepatitis C antibody positive
• Treatment with infliximab within 12 weeks of study entry
• Treatment with rituximab
• Treatment with medications known to be metabolized by the cytochrome P3A4 pathway.More information about this criterion can be found in the protocol.
• Require amiodarone or verapamil
• Investigational drug or treatment during the 4 weeks or seven half-lives prior tostudy entry
• History of alcohol abuse
• History of liver disease, current liver disease (e.g., hepatitis, cirrhosis), orabnormal liver function (AST or ALT greater than 2 times the upper limit of normal [ULN])
• Any condition that, in the opinion of the investigator, may interfere with the study
• Pregnancy or breastfeeding