Serologically Active, Clinically Stable Systemic Lupus Erythematosus

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT00000421

Run by

NYU Langone Health

People needed

154

Starts

1997-09-01

Expected to finish

2003-08-01

Last updated by the study team

2016-03-04

Who can join

Age: 13 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Meets ACR criteria for SLE
• Inactive or stable in lupus activity
• History of positive dsDNA
• Current prednisone dose no more than 15 mg daily

You may not qualify if…

• Active infections
• Poorly controlled diabetes mellitus
• Pregnancy
• Uncontrolled hypertension

Where it is running

• North Shore-Long Island Jewish Health System — New Hyde Park, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Office of Betty Diamond, M.D. — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.