Status:
UNKNOWN
An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus
Lead Sponsor:
Buddhist Tzu Chi General Hospital
Collaborating Sponsors:
Pfizer
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
16-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 16-80 years of age, fulfilling ACR criteria for the classification of SLE (no limit on disease duration)
- 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.
- The type and number immunosuppressive agents were not changed in recent one months
Exclusion
- inability to give informed consent;
- myositis (CK\>3×normal value);
- dialysis or serum creatinin\>2.5mg/dL;
- abnormal liver function (ALT\>3×normal value);
- pregnant or breastfeeding;
- life-threatening illness that would interfere with ability to complete the study;
- current drug or alcohol abuse
- Already under statin therapy
- Active SLE disease need added new immunosuppressive agent or increased current drug dosage for more than 50%.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
End Date :
March 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00432354
Start Date
March 1 2007
End Date
March 1 2009
Last Update
March 20 2007
Active Locations (2)
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1
Dalin Tzu Chi General Hospital
Chiayi City, Chia-yi, Taiwan, 622
2
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, Taiwan, 622