Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00302952

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

64

Starts

2007-11-06

Expected to finish

2012-04-30

Last updated by the study team

2022-09-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Justus J. Fiechtner, MD, PLLC — Lansing, Michigan, United States
• Feinstein Institute for Medical Research NS-LIJ Health System — Manhasset, New York, United States
• University of Rochester — Rochester, New York, United States
• Carolina Bone and Joint — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baylor Research Institute — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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