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Serologically Active, Clinically Stable Systemic Lupus Erythematosus (SACS-SLE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000421
First Posted: November 4, 1999
Last Update Posted: March 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus Drug: Prednisone Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Serologically Active, Clinically Stable Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Clinical flare with or without serological flare, or serological flare while clinically stable [ Time Frame: 18 months ]

Enrollment: 154
Study Start Date: September 1997
Study Completion Date: August 2003
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prednisone arm
Patients who remained clinically stable but showed serologic evidence of a lupus flare (elevation of both the anti-dsDNA level by 25% and the C3a level by 50% over the previous 1-2 monthly visits) were randomized receive either prednisone or placebo therapy at a dosage of 30 mg/day for 2 weeks, 20 mg/day for 1 week and 10 mg/day for 1 week.
Drug: Prednisone
Placebo Comparator: Placebo
Patients who remained clinically stable but showed serologic evidence of a lupus flare (elevation of both the anti-dsDNA level by 25% and the C3a level by 50% over the previous 1-2 monthly visits) were randomized receive either prednisone or placebo therapy at a dosage of 30 mg/day for 2 weeks, 20 mg/day for 1 week and 10 mg/day for 1 week.
Drug: Placebo

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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000421


Locations
United States, New York
Office of Betty Diamond, M.D.
Bronx, New York, United States, 10461
North Shore-Long Island Jewish Health System
New Hyde Park, New York, United States, 11040
Lenox Hill Hospital
New York, New York, United States, 10002
Sponsors and Collaborators
New York University School of Medicine
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Steven B. Abramson Hospital for Joint Diseases
  More Information

Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00000421     History of Changes
Other Study ID Numbers: R01AR044690 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: March 4, 2016
Last Verified: March 2016

Keywords provided by New York University School of Medicine:
SLE
Lupus
Anti-double-stranded DNA antibody
Corticosteroid treatment
Hormone therapy
Complement
Hypertension
Estrogen
SELENA

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents