An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

NCT00432354

Last updated date
Study Location
Buddhist Dalin Tzu Chi General Hospital
Chia-Yi, , 622, Taiwan
Contact
886-5-2648000

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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%.

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NCT00432354
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Advanced Information
Descriptive Information
Brief Title  ICMJE An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus
Official Title  ICMJE Not Provided
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Drug: atorvastatin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: February 6, 2007)
40
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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%.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00432354
Other Study ID Numbers  ICMJE DTCRD 96-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Buddhist Tzu Chi General Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Ning-Sheng Lai, MD., Ph.D.Vice President of Buddhist Dalin Chi Tzu General Hospital
PRS Account Buddhist Tzu Chi General Hospital
Verification Date March 2007

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