Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Lovastatin; Placebo
Intervention description: Two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion; Two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Arthritis, Rheumatoid

Summary:

      Rheumatoid arthritis (RA) is the most common inflammatory arthritis and a major health
      problem. The purpose of this study is to determine the safety and effectiveness of lovastatin
      for controlling inflammation in mildly active RA.
    

Eligibility criteria:

        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 more
             than six swollen and eight tender joints

          -  If on corticosteroids, dose must be stable and 10 mg/day prednisone (or equivalent) or
             less 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 joint
             replacement 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 lupus
             erythematosus (SLE), psoriatic arthritis, gout, scleroderma, or known reactive
             arthritis (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 to
             study entry

          -  History of alcohol abuse

          -  History of liver disease, current liver disease (e.g., hepatitis, cirrhosis), or
             abnormal 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