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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Autoimmunity Centers of Excellence |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00302952 |
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.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Lovastatin Device: Lovastatin placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind, Placebo Controlled, Phase II, Randomized Study of Lovastatin Therapy in the Treatment of Mildly Active Rheumatoid Arthritis |
Estimated Enrollment: | 80 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive lovastatin daily for 12 weeks
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Drug: Lovastatin
80 mg oral tablet taken daily
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2: Placebo Comparator
Participants will receive lovastatin placebo daily for 12 weeks
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Device: Lovastatin placebo
Oral placebo tablet taken daily
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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. Arm A will receive 80 mg lovastatin daily for 12 weeks; Arm B will receive placebo.
There will be four study visits over the 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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: S. Louis Bridges, Jr, MD, PhD 205-934-7995 LBridges@uab.edu | |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Maria Dall'Era, MD 415-502-1886 maria.dallera@ucsf.edu | |
United States, Colorado | |
University of Colorado | Recruiting |
Aurora, Colorado, United States, 80095 | |
Contact: Jann Wagner 303-724-7516 Janice.Wagner@uchsc.edu | |
United States, Michigan | |
Justus Flechtner, MD, PC | Recruiting |
Lansing, Michigan, United States, 48910 | |
Contact: Justus Fletchner, MD, PC 517-272-9727 researchinfo21@hotmail.com | |
United States, New York | |
Feinstein Institute for Medical Research NS-LIJ Health System | Recruiting |
Manhasset, New York, United States, 11030 | |
Contact: Cynthia Aranow, MD 516-562-3837 caranow@nshs.edu | |
University of Rochester | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: R. John Looney, MD 585-275-5308 John_Looney@urmc.rochester.edu | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Edna Scarlett 919-684-6150 scarl001@mc.duke.edu | |
Carolina Bone and Joint | Recruiting |
Charlotte, North Carolina, United States, 29425 | |
Contact: Sophia Rosemond 704-541-3055 srosemond@bonesrus.org | |
United States, Pennsylvania | |
University of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15261 | |
Contact: Mary Chester Wasko, MD 412-383-8846 waskomc@dom.pitt.edu | |
Altoona Center for Clinical Research | Recruiting |
Duncansville, Pennsylvania, United States, 16635 | |
Contact: Renea Weyandt 814-693-0300 reneaweyandt1125@yahoo.com | |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Amanda Oswald 843-792-2014 Oswalkd@musc.edu | |
United States, Utah | |
University of Utah | Not yet recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Tracy Frech, MD 801-581-4333 tracy.frech@hsc.utah.edu |
Study Chair: | Cynthia Aranow, MD | Feinstein Institute for Medical Research NS-LIJ Health System |
Study Chair: | Betty Diamond, MD | Feinstein Institute for Medical Research NS-LIJ Health System |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | DAIT ARA02 |
Study First Received: | March 13, 2006 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00302952 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Autoimmune Diseases Musculoskeletal Diseases Antilipemic Agents Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Anticholesteremic Agents Rheumatic Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Lovastatin |
Antimetabolites Autoimmune Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Joint Diseases Antilipemic Agents Arthritis, Rheumatoid Enzyme Inhibitors Rheumatic Diseases |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Musculoskeletal Diseases Therapeutic Uses Arthritis Connective Tissue Diseases Lovastatin |