Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00302952
Status:
TERMINATED
Last Update Posted:
2022-09-07
First Post:
2006-03-13
Brief Title:
Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Double Blind Placebo Controlled Phase II Randomized Study of Lovastatin Therapy in the Treatment of Mildly Active Rheumatoid Arthritis
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment Study Drug Expiration Target 40 randomized participants arm
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inflammation in mildly active RA
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None