An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

NCT00432354 | Unknown Phase 2

• 1 other identifier: DTCRD 96-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

statin; systemic lupus erythematosus; microcirculation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

atorvastatin DRUG

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead
• Pfizer: collaborator

Study Sites (2)

Dalin Tzu Chi General Hospital

Chiayi City, Chia-yi, 622, Taiwan

RECRUITING

Buddhist Dalin Tzu Chi General Hospital

Chiayi City, 622, Taiwan

NOT YET RECRUITING

Related Publications (2)

• Kiss E, Soltesz P, Der H, Kocsis Z, Tarr T, Bhattoa H, Shoenfeld Y, Szegedi G. Reduced flow-mediated vasodilation as a marker for cardiovascular complications in lupus patients. J Autoimmun. 2006 Dec;27(4):211-7. doi: 10.1016/j.jaut.2006.09.008. Epub 2006 Nov 7.

  PMID: 17088047 BACKGROUND

• McCarey DW, McInnes IB, Madhok R, Hampson R, Scherbakov O, Ford I, Capell HA, Sattar N. Trial of Atorvastatin in Rheumatoid Arthritis (TARA): double-blind, randomised placebo-controlled trial. Lancet. 2004 Jun 19;363(9426):2015-21. doi: 10.1016/S0140-6736(04)16449-0.

  PMID: 15207950 RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Ning-Sheng Lai, MD., Ph.D.

  Vice President of Buddhist Dalin Chi Tzu General Hospital

  STUDY CHAIR

Central Study Contacts

Ming-Chi Lu, MD

CONTACT

886-5-2648000; e360187@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2007
• First Posted: February 7, 2007
• Study Start: March 1, 2007
• Study Completion: March 1, 2009
• Last Updated: March 20, 2007

Record last verified: 2007-03

Locations

TW (2)