Status:
TERMINATED
Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Autoimmunity Centers of Excellence
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 inf...
Detailed Description
RA is characterized by persistent inflammation of peripheral joints, causing pain, stiffness, swelling, and warmth. The inflammation may cause progressive joint damage and destruction, resulting in de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 6 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00302952
Start Date
November 6 2007
End Date
April 30 2012
Last Update
September 7 2022
Active Locations (15)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
University of Colorado
Aurora, Colorado, United States, 80095
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637