An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

• Status: Unknown status
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Buddhist Tzu Chi General Hospital
• Collaborator: Pfizer
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

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%.