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Serologically Active, Clinically Stable Systemic Lupus Erythematosus Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Serologically Active, Clinically Stable Systemic Lupus Erythematosus conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Serologically Active, Clinically Stable Systemic Lupus Erythematosus Clinical research trials and Serologically Active, Clinically Stable Systemic Lupus Erythematosus health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Serologically Active, Clinically Stable Systemic Lupus Erythematosus. Serologically Active, Clinically Stable Systemic Lupus Erythematosus Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Serologically Active, Clinically Stable Systemic Lupus Erythematosus clinical trial. Subjects frequently get the best healthcare possible for their Serologically Active, Clinically Stable Systemic Lupus Erythematosus condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Serologically Active, Clinically Stable Systemic Lupus Erythematosus  Serologically Active, Clinically Stable Systemic Lupus Erythematosus
Serologically Active, Clinically Stable Systemic Lupus Erythematosus
For Condition: Systemic Lupus Erythematosus
Status: No longer recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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 patient's 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.
Details: 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 1,000 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 (e.g., 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 13 Years/65 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Meets ACR criteria for SLE - Inactive or stable in lupus activity - History of positive dsDNA - Current prednisone dose no more than 15 mg daily Exclusion Criteria: - Active infections - Poorly controlled diabetes mellitus - Pregnancy - Uncontrolled hypertension
Total Enrollment: 80
Location and Contact Information:
Overall Study Official:
StevenAbramson, Principal Investigator, Hospital for Joint Diseases
North Shore-Long Island Jewish Health System
New Hyde Park, New York, 11040
United States
Office of Betty Diamond, M.D.
Bronx, New York, 10461
United States
Lenox Hill Hospital
New York City, New York, 10002
United States
Additional Information:
Study ID Numbers: NIAMS-026; R01 AR44690
Study Start Date: September 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000421
Other Systemic Lupus Erythematosus Studies:
1. The Research Registry for Neonatal Lupus
2. Drug Therapy in Lupus Nephropathy
3. Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture
4. Monoclonal Antibody Treatment for Systemic Lupus Erythematosus
5. Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus
Related Studies:
Other Systemic Lupus Erythematosus Clinical Trials
Other New York Clinical Trials
Other New Hyde Park Clinical Trials
Serologically Active, Clinically Stable Systemic Lupus Erythematosus
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