Serologically Active, Clinically Stable Systemic Lupus Erythematosus
SACS-SLE
1 other identifier
interventional
154
1 country
3
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 1997
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedFirst Posted
Study publicly available on registry
November 4, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedMarch 4, 2016
March 1, 2016
4.9 years
November 3, 1999
March 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical flare with or without serological flare, or serological flare while clinically stable
18 months
Study Arms (2)
Prednisone arm
ACTIVE COMPARATORPatients 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.
Placebo
PLACEBO COMPARATORPatients 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.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
North Shore-Long Island Jewish Health System
New Hyde Park, New York, 11040, United States
Lenox Hill Hospital
New York, New York, 10002, United States
Office of Betty Diamond, M.D.
The Bronx, New York, 10461, United States
Related Publications (4)
Belmont HM, Hopkins P, Edelson HS, Kaplan HB, Ludewig R, Weissmann G, Abramson S. Complement activation during systemic lupus erythematosus. C3a and C5a anaphylatoxins circulate during exacerbations of disease. Arthritis Rheum. 1986 Sep;29(9):1085-9. doi: 10.1002/art.1780290905.
PMID: 3489467BACKGROUNDHopkins P, Belmont HM, Buyon J, Philips M, Weissmann G, Abramson SB. Increased levels of plasma anaphylatoxins in systemic lupus erythematosus predict flares of the disease and may elicit vascular injury in lupus cerebritis. Arthritis Rheum. 1988 May;31(5):632-41. doi: 10.1002/art.1780310508.
PMID: 3259882BACKGROUNDBuyon JP, Tamerius J, Belmont HM, Abramson SB. Assessment 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. Arthritis Rheum. 1992 Sep;35(9):1028-37. doi: 10.1002/art.1780350907.
PMID: 1418018BACKGROUNDTseng CE, Buyon JP, Kim M, Belmont HM, Mackay M, Diamond B, Marder G, Rosenthal P, Haines K, Ilie V, Abramson SB. The 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. Arthritis Rheum. 2006 Nov;54(11):3623-32. doi: 10.1002/art.22198.
PMID: 17075807RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven B. Abramson
Hospital for Joint Diseases
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
September 1, 1997
Primary Completion
August 1, 2002
Study Completion
August 1, 2003
Last Updated
March 4, 2016
Record last verified: 2016-03