Complement activation during systemic lupus erythematosus. C3a and C5a anaphylatoxins circulate during exacerbations of disease.
H M Belmont, P Hopkins, H S Edelson...
https://pubmed.ncbi.nlm.nih.gov/3489467Completed
Phase 2
Age: 13Years - 65Years
FEMALE
ID00000421
Serologically Active, Clinically Stable Systemic Lupus Erythematosus (SLE)
Led by NYU Langone Health · Updated on 2016-03-04
154
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Serologically Active, Clinically Stable Systemic Lupus Erythematosus
Who Can Participate
Age: 13Years - 65Years
FEMALE
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Active infections
- Poorly controlled diabetes mellitus
- Pregnancy
- Uncontrolled hypertension
Trial Site Locations
Total: 3 locations
1
North Shore-Long Island Jewish Health System
New Hyde Park, New York, United States, 11040
Status Unknown
2
Lenox Hill Hospital
New York, New York, United States, 10002
Status Unknown
3
Office of Betty Diamond, M.D.
The Bronx, New York, United States, 10461
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Increased levels of plasma anaphylatoxins in systemic lupus erythematosus predict flares of the disease and may elicit vascular injury in lupus cerebritis.
P Hopkins, H M Belmont, J Buyon...
https://pubmed.ncbi.nlm.nih.gov/3259882Assessment of disease activity and impending flare in patients with systemic lupus erythematosus. Comparison of the use of complement split products and conventional measurements of complement.
J P Buyon, J Tamerius, H M Belmont...
https://pubmed.ncbi.nlm.nih.gov/1418018The effect of moderate-dose corticosteroids in preventing severe flares in patients with serologically active, but clinically stable, systemic lupus erythematosus: findings of a prospective, randomized, double-blind, placebo-controlled trial.
Chung-E Tseng, Jill P Buyon, Mimi Kim...
https://pubmed.ncbi.nlm.nih.gov/17075807