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
  Purpose

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


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: atorvastatin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • The primary outcome was the change in SLE-DAI, a validated composite disease activity score.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 40
Study Start Date: March 2007
Estimated Study Completion Date: March 2009
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 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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432354

Contacts
Contact: Ming-Chi Lu, MD 886-5-2648000 ext 5201 e360187@yahoo.com.tw

Locations
Taiwan
Buddhist Dalin Tzu Chi General Hospital Not yet recruiting
Chia-Yi, Taiwan, 622
Contact: Ming-Chi Lu, MD    886-5-2648000 ext 5201    e360187@yahoo.com.tw   
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    e360187@yahoo.com.tw   
Contact: Ning-Sheng Lai, MD, Phd    05-2648000 ext 5006      
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Pfizer
Investigators
Study Chair: Ning-Sheng Lai, MD., Ph.D. Vice President of Buddhist Dalin Chi Tzu General Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00432354     History of Changes
Other Study ID Numbers: DTCRD 96-03
Study First Received: February 6, 2007
Last Updated: March 19, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by Buddhist Tzu Chi General Hospital:
statin
systemic lupus erythematosus
microcirculation

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014