Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis

• Status: Terminated
• Trial end date: 2012-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Autoimmunity Centers of Excellence
• Treatments: Dihydromevinolin; L 647318; Lovastatin

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