An Open Labeled Pilot Study of Atorvastatin in Systemic L... | NCT00432354

Studies
An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

NCT00432354

Sponsor

Buddhist Tzu Chi General Hospital

Status

Unknown status

Last Update Posted

Mar 20, 2007Estimated

Enrollment

Phase

Phase 2Phase 3

Conditions

Systemic Lupus Erythematosus

Interventions

atorvastatin

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Mar 2009Estimated

First Submitted Date

Feb 6, 2007

First Submission Date that Met QC Criteria

Feb 6, 2007

First Posted Date

Feb 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2007

Last Update Posted Date

Mar 20, 2007Estimated

Name	Class
Pfizer	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
atorvastatin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome was the change in SLE-DAI, a validated composite disease activity score.

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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%.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ming-Chi Lu, MD	Contact	886-5-2648000	5201	e360187@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Ning-Sheng Lai, MD., Ph.D.	Vice President of Buddhist Dalin Chi Tzu General Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dalin Tzu Chi General Hospital	Recruiting	Chiayi City	Chia-yi	622	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17088047	Background	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.
15207950	Result	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.

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds