An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Buddhist Tzu Chi General Hospital

February 6, 2007
February 7, 2007
March 20, 2007
March 2007
Not Provided
The primary outcome was the change in SLE-DAI, a validated composite disease activity score.
Same as current
Complete list of historical versions of study NCT00432354 on Archive Site
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.
Same as current
Not Provided
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An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus
Not Provided
The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.

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.

Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
Drug: atorvastatin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
March 2009
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Inclusion Criteria:

  1. 16–80 years of age, fulfilling ACR criteria for the classification of SLE (no limit on disease duration)
  2. Active disease status including (1) active nephritis with moderate proteinuria (between 1.0gm/day and 2.5gm/day) despite ongoing immunosuppressive therapy or (2) moderate active extra-renal component of the SLEDAI score in the range of 3 to 10. The SLE-DAI score should have been stable for at least two weeks prior to screening.
  3. The type and number immunosuppressive agents were not changed in recent one months

Exclusion Criteria:

  1. inability to give informed consent;
  2. myositis (CK>3×normal value);
  3. dialysis or serum creatinin>2.5mg/dL;
  4. abnormal liver function (ALT>3×normal value);
  5. pregnant or breastfeeding;
  6. life-threatening illness that would interfere with ability to complete the study;
  7. current drug or alcohol abuse
  8. Already under statin therapy
  9. Active SLE disease need added new immunosuppressive agent or increased current drug dosage for more than 50%.
Sexes Eligible for Study: All
16 Years to 80 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
DTCRD 96-03
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Buddhist Tzu Chi General Hospital
Study Chair: Ning-Sheng Lai, MD., Ph.D. Vice President of Buddhist Dalin Chi Tzu General Hospital
Buddhist Tzu Chi General Hospital
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP