An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus
|ClinicalTrials.gov Identifier: NCT00432354|
Recruitment Status : Unknown
Verified March 2007 by Buddhist Tzu Chi General Hospital.
Recruitment status was: Recruiting
First Posted : February 7, 2007
Last Update Posted : March 20, 2007
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: atorvastatin||Phase 2 Phase 3|
Background: Statins are lipid-lower agents with pleiotropic effects. Beyond the traditional effect as inhibitors of 3-hydroxy-3methylglytaryl coenzyme A (HMG-CoA) reductase, it has anti-inflammatory and immunomodulatory properties. The administration of atorvastatin to lupus-prone model NZB/W F1 mice results in a significant reduction in serum IgG anti-dsDNA Abs and decreased proteinuria. In a pilot study with three patients with SLE, simvastatin induced rapid and significant reduction in proteinuria levels. However, further randomized double-blinded placebo-controlled study is pending.
Objective: The goal of this study was to evaluate the clinical efficacy and laboratory effect of atorvastatin in SLE.
Methods: Forty patients with SLE will randomize in two groups to receive atorvastatin or not as an adjuvant to immunosuppressive agent therapy. Patients who received atorvastatin for 6 months will stop atorvastatin for 8 weeks as a washout period. We will cross over the placebo and experimental groups, then given atorvastatin for another 6 months. Primary outcome is improvement of lupus disease status measured by SLEDAI and microcirculation improvement via nailfold capillaroscopy.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2007|
|Estimated Study Completion Date :||March 2009|
- The primary outcome was the change in SLE-DAI, a validated composite disease activity score.
- The secondary endpoint was the improvement of microcirculation evaluated by Raynaud’s condition score and nailfold capillaroscopy in the beginning and end of the atorvastatin.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432354
|Contact: Ming-Chi Lu, MD||886-5-2648000 ext firstname.lastname@example.org|
|Buddhist Dalin Tzu Chi General Hospital||Not yet recruiting|
|Chia-Yi, Taiwan, 622|
|Contact: Ming-Chi Lu, MD 886-5-2648000 ext 5201 email@example.com|
|Principal Investigator: Ming-Chi Lu, MD|
|Dalin Tzu Chi General Hospital||Recruiting|
|Chia-yi, Taiwan, 622|
|Contact: Ming-Chi Lu, MD 05-2648000 ext 5201 firstname.lastname@example.org|
|Contact: Ning-Sheng Lai, MD, Phd 05-2648000 ext 5006|
|Study Chair:||Ning-Sheng Lai, MD., Ph.D.||Vice President of Buddhist Dalin Chi Tzu General Hospital|