N/A
N/A
Female
Systemic Lupus Erythematosus
Trial Information
PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
Patients are stratified according to age/menopausal status (35 and under/premenopausal vs 50
and over/postmenopausal). Both strata are randomized to one of two treatment arms.
Stratum 1 (Premenopausal/Oral contraceptives): Patients receive either oral ethinyl
estradiol and norethindrone or placebo daily for 28 days beginning on the Sunday following
the first day of the menstrual cycle.
Stratum 2 (Postmenopausal/Hormone replacement therapy): Patients receive either oral
estradiol and medroxyprogesterone or placebo on days 1-12 monthly.
Treatment continues in both arms of both strata for a total of 13 courses in the absence of
a severe disease flare-up or other complication that would preclude further study
participation.
All patients are followed at 1 year.
Inclusion Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Established systemic lupus erythematosus meeting American College of Rheumatology criteria
Inactive disease Systemic Lupus Erythematosus Activity Index (SLEDAI) score no greater
than 4
No increase in score of more than 2 from baseline over the past 3 months
Receiving the equivalent of 5 mg or less of prednisone per day OR Stable/active disease
SLEDAI score 5-12
No increase in score of more than 2 from baseline over the past 3 months
Prednisone dose up to 0.5 mg/kg/day for control of underlying disease allowed if stable
dose for at least 3 weeks
No concurrent severe disease activity as defined by any of the following:
- Acute renal disease (i.e., rising creatinine levels, cellular sediment, or increasing
proteinuria)
- Involvement of 3 or more organ systems requiring more than the equivalent of 0.5
mg/kg/day of prednisone
- Necessity of immediate hospitalization for symptom control
No presence of a high titer IgG, IgM, or IgA antiphospholipid antibodies (aPL) GPL and MPL
no more than 40 APL no more than 50
No features of primary antiphospholipid antibody syndrome
--Prior/Concurrent Therapy--
Biologic therapy: Not specified
Chemotherapy: Not specified
Endocrine therapy: See Disease Characteristics
Radiotherapy: Not specified
Surgery: Prior hysterectomy allowed
--Patient Characteristics--
Age: 35 and under for oral contraceptive stratum (premenopausal) 50 and over for hormone
replacement therapy stratum (postmenopausal)
Menopausal status:
- Premenopausal for oral contraceptive stratum
- Postmenopausal for hormone replacement therapy stratum
- Follicle-stimulating hormone greater than 40 mIU/mL OR Amenorrhea for 6 months
Performance status: See Disease Characteristics
Hematopoietic: Not specified
Hepatic:
- No hepatic dysfunction
- No tumors of the liver
Renal: See Disease Characteristics
Cardiovascular:
- No uncontrolled high blood pressure requiring frequent change in medication
- Concurrent hypertension controlled with stable medication allowed
- No history of spontaneous superficial or deep venous thrombosis or arterial
thrombosis
- No prior myocardial infarction
- Oral contraceptive stratum: No angina No diastolic blood pressure greater than 90 mm
Hg or systolic blood pressure greater than 140 mm Hg on 3 separate determinations
- Hormone replacement therapy stratum: No diastolic blood pressure greater than 95 mm
Hg or systolic blood pressure greater than 145 mm Hg on 3 separate determinations
Pulmonary: No history of pulmonary embolus
Other:
- Not pregnant
- Oral contraceptive stratum: Negative pregnancy test Fertile patients must use
effective barrier contraception
- No prior gynecologic malignancy or breast malignancy
- No undiagnosed vaginal bleeding
- No diabetes (present prior to use of glucocorticoids) requiring oral hypoglycemic
medications or insulin
- No congenital hyperlipidemia
- No complicated migraines (i.e., associated with neurological sequelae)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Principal Investigator
Graciela S. Alarcon
Investigator Role:
Study Chair
Investigator Affiliation:
University of Alabama at Birmingham
Authority:
United States: Federal Government
Study ID:
199/15327
NCT ID:
NCT00006133
Start Date:
June 2000
Completion Date:
Related Keywords:
- Systemic Lupus Erythematosus
- arthritis & connective tissue diseases
- immunologic disorders and infectious disorders
- rare disease
- systemic lupus erythematosus
- Lupus Erythematosus, Systemic
Name | Location |
|---|---|
| University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Montefiore Medical Center | Bronx, New York 10467-2490 |
| Louisiana State University School of Medicine | New Orleans, Louisiana 70112-2822 |
| University of Texas- Houston Medical School | Houston, Texas 77030 |
| University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
| University of California Los Angeles | Los Angeles, California 90095-6951 |
| University of California-San Francisco | San Francisco, California 94143 |
| Pritzker School of Medicine | Chicago, Illinois 60637 |
| Johns Hopkins University School of Medicine | Baltimore, Maryland 21205 |
| University of Michigan Health Systems | Ann Arbor, Michigan 48109 |
| Hospital for Joint Diseases | New York, New York 10003 |
| Hospital for Special Surgery | New York, New York 10021 |
| Saint Luke's-Roosevelt Hospital Center | New York, New York 10019 |
| Rheumatology Associates of Long Island | Port Jefferson Station, New York 11776 |
| University of North Carolina | Chapel Hill, North Carolina 27599 |
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
