Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000421
Status:
COMPLETED
Last Update Posted:
2016-03-04
First Post:
1999-11-03
Brief Title:
Serologically Active Clinically Stable Systemic Lupus Erythematosus
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Serologically Active Clinically Stable Systemic Lupus Erythematosus SLE
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SACS-SLE
Brief Summary:
The first part of this study will use the database of a large ongoing NIH-sponsored lupus study Safety of Estrogen in Lupus Erythematosus National Assessment We will examine the levels of a blood protein known as C3a in a series of patient blood samples to see if C3a levels predict lupus flares or are better than other blood tests and therefore should be used more widely in managing lupus In the second part of the study we will add or increase prednisone treatment on the basis of abnormalities in blood tests for C3a and dsDNA antibodies Early treatment based on increases in C3a and dsDNA antibodies before the patient develops physical signs of disease may reduce lupus flares and ultimately the patients total steroid exposure
We will follow study participants for 1 year on a monthly basis and do full physical examinations and laboratory evaluations If C3a and dsDNA antibody levels are increased significantly above baseline levels while a patient is clinically stable we will give the patient either prednisone or an inactive pill placebo for 1 month We will follow these patients monthly to compare how often lupus flares occur in the two groups This approach could provide a novel method of preventing lupus flares using C3a as a sensitive predictor of flare
We will follow study participants for 1 year on a monthly basis and do full physical examinations and laboratory evaluations If C3a and dsDNA antibody levels are increased significantly above baseline levels while a patient is clinically stable we will give the patient either prednisone or an inactive pill placebo for 1 month We will follow these patients monthly to compare how often lupus flares occur in the two groups This approach could provide a novel method of preventing lupus flares using C3a as a sensitive predictor of flare
Detailed Description:
In lupus serial evaluation of dsDNA antibody titers and complement C3 and C4 in blood samples have been useful in assessing disease activity in patients High levels of C3a a split product of C3 are particularly sensitive and reflective of lupus flares Our study looks at whether elevations in C3a can predict lupus flares and how C3a compares with other conventional blood indicators such as dsDNA antibody C3 C4 and CH50 The utility of serial anti-dsDNA antibodies and complement measurements in clinical decision-making for people with systemic lupus erythematosus SLE remains controversial This study has two specific parts designed to address these issues
In the first we will take advantage of a unique opportunity to collaborate with a large multicenter NIH-sponsored protocol the Safety of Estrogens in Systemic Lupus National Assessment SELENA trial We will perform an observational study of approximately 1000 women enrolled in the SELENA trial to assess the sensitivity specificity and predictive value of anti-dsDNA antibodies C3 C4 CH50 and C3a desArg Using samples from patients enrolled in the SELENA study we will perform subgroup analyses in diverse ethnic groups patients treated with exogenous estrogen and patients with chronically depressed CH50
In the second-an interventional study-we will evaluate the effectiveness of short-term corticosteroid treatment in averting flares when elevations of plasma C3a are accompanied by rising anti-dsDNA antibody We will determine whether corticosteroid treatment reduces the frequency of clinical flare serological abnormalities or disease activity in inactive or stable patients We will explore whether steroids disproportionately exacerbate or initiate comorbid medical conditions eg hypertension diabetes that may be more prevalent among minority patients The studies should result in observations that lead to rational cost-effective and evidence-based guidelines that improve the treatment of patients with SLE and-by decreasing the morbidity of disease-result in significant improvement of their quality of life
In the first we will take advantage of a unique opportunity to collaborate with a large multicenter NIH-sponsored protocol the Safety of Estrogens in Systemic Lupus National Assessment SELENA trial We will perform an observational study of approximately 1000 women enrolled in the SELENA trial to assess the sensitivity specificity and predictive value of anti-dsDNA antibodies C3 C4 CH50 and C3a desArg Using samples from patients enrolled in the SELENA study we will perform subgroup analyses in diverse ethnic groups patients treated with exogenous estrogen and patients with chronically depressed CH50
In the second-an interventional study-we will evaluate the effectiveness of short-term corticosteroid treatment in averting flares when elevations of plasma C3a are accompanied by rising anti-dsDNA antibody We will determine whether corticosteroid treatment reduces the frequency of clinical flare serological abnormalities or disease activity in inactive or stable patients We will explore whether steroids disproportionately exacerbate or initiate comorbid medical conditions eg hypertension diabetes that may be more prevalent among minority patients The studies should result in observations that lead to rational cost-effective and evidence-based guidelines that improve the treatment of patients with SLE and-by decreasing the morbidity of disease-result in significant improvement of their quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR044690 | NIH | None | httpsreporternihgovquickSearchR01AR044690 |