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Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Lovastatin (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Cynthia Aranow, MD, Study Chair, Affiliation: Feinstein Institute for Medical Research NS-LIJ Health System
Betty Diamond, MD, Study Chair, Affiliation: Feinstein Institute for Medical Research NS-LIJ Health System

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.

Clinical Details

Official title: A Double Blind, Placebo Controlled, Phase II, Randomized Study of Lovastatin Therapy in the Treatment of Mildly Active Rheumatoid Arthritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome:

Adjusted Mean Change From Baseline in Log Transformed C - Reactive Protein (CRP) at Day 84

Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84

Change From Baseline in Total Bilirubin, Creatinine, BUN, Phosphorus, Calcium, and Glucose at Day 84

Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscular Hemoglobin Concentration (MCHC) at Day 84

Change From Baseline in Potassium, Sodium, Chloride, and Total CO2 at Day 84

Change From Baseline in CPK at Day 84

Change From Baseline in Counts: White Blood Cells (WBC), Neutrophils, Bands, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, and Reticulocytes at Day 84

Change From Baseline in Hematocrit (Hct) at Day 84

Change From Baseline in Red Cell Distribution Width (RDW) at Day 84

Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Day 84

Change From Baseline in Mean Corpuscular Volume (MCV) at Day 84

Secondary outcome:

Adjusted Mean Change From Baseline in the Disease Activity Score Using C-reactive Protein (DAS28-CRP) on Day 84

Percentage of Participants Meeting ACR20 Response Criteria at Day 84 (ACR: American College of Rheumatology)

Adjusted Mean Change From Baseline in Serum IgM Rheumatoid Factor by ELISA (ELISA: Enzyme-linked Immunosorbent Assay)

Adjusted Mean Change From Baseline in Serum Anti-cyclic Citrullinated Peptide (Anti-CCP) by ELISA (ELISA: Enzyme-linked Immunosorbent Assay)

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 deformity and loss of function. Both traditional and biologic disease-modifying antirheumatic drugs (DMARDs) have been prescribed for RA patients to control existing inflammatory symptoms and affect long-term prognosis. However, DMARD use is expensive, and the long-term safety of DMARDs is unknown. Lovastatin is an HMG-CoA reductase inhibitor (also known as a statin) used to lower levels of cholesterol and other fats in the blood. The purpose of this study is to examine the safety and efficacy of lovastatin in controlling inflammation in individuals with RA who have mildly active RA disease despite treatment. Participants will be randomly assigned to one of two study arms (Experimental or Placebo). There will be four study visits over 12 weeks. At each visit, a physical exam, vital signs measurement, medication history, a pregnancy test (if applicable), and blood collection will occur. Additional safety blood testing will occur at Week 2. Tender and swollen joint counts and a Physician Global Assessment will occur at study entry and Week 12. Participants will also be asked to complete self-assessments at study entry and Week 12.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

University of Alabama, Birmingham, Alabama 35294, United States

University of California, San Francisco, San Francisco, California 94143, United States

University of Colorado, Aurora, Colorado 80095, United States

University of Chicago Medical Center, Chicago, Illinois 60637, United States

Justus J. Fiechtner, MD, PLLC, Lansing, Michigan 48910, United States

Feinstein Institute for Medical Research NS-LIJ Health System, Manhasset, New York 11030, United States

University of Rochester, Rochester, New York 14642, United States

Carolina Bone and Joint, Charlotte, North Carolina 29425, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 73104, United States

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15261, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Baylor Research Institute, Dallas, Texas 75231, United States

University of Utah, Salt Lake City, Utah 84132, United States

Additional Information

Related publications:

Abud-Mendoza C, de la Fuente H, Cuevas-Orta E, Baranda L, Cruz-Rizo J, González-Amaro R. Therapy with statins in patients with refractory rheumatic diseases: a preliminary study. Lupus. 2003;12(8):607-11.

McCarey DW, McInnes IB, Madhok R, Hampson R, Scherbakov O, Ford I, Capell HA, Sattar N. Trial of Atorvastatin in Rheumatoid Arthritis (TARA): double-blind, randomised placebo-controlled trial. Lancet. 2004 Jun 19;363(9426):2015-21.

Starting date: August 2006
Last updated: February 12, 2014

Page last updated: August 23, 2015

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