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An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Buddhist Tzu Chi General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT00432354
First received: February 6, 2007
Last updated: March 19, 2007
Last verified: March 2007

February 6, 2007
March 19, 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 ClinicalTrials.gov 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
Not Provided
 
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Systemic Lupus Erythematosus
Drug: atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
March 2009
Not Provided

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%.
Both
16 Years to 80 Years
No
Contact: Ming-Chi Lu, MD 886-5-2648000 ext 5201 e360187@yahoo.com.tw
Taiwan
 
NCT00432354
DTCRD 96-03
Not Provided
Not Provided
Buddhist Tzu Chi General Hospital
Pfizer
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