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Female
Systemic Lupus Erythematosus

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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 CenterBirmingham, Alabama  35294
Medical College of WisconsinMilwaukee, Wisconsin  53226
Montefiore Medical CenterBronx, New York  10467-2490
Louisiana State University School of MedicineNew Orleans, Louisiana  70112-2822
University of Texas- Houston Medical SchoolHouston, Texas  77030
University of PittsburghPittsburgh, Pennsylvania  15261
University of California Los AngelesLos Angeles, California  90095-6951
University of California-San FranciscoSan Francisco, California  94143
Pritzker School of MedicineChicago, Illinois  60637
Johns Hopkins University School of MedicineBaltimore, Maryland  21205
University of Michigan Health SystemsAnn Arbor, Michigan  48109
Hospital for Joint DiseasesNew York, New York  10003
Hospital for Special SurgeryNew York, New York  10021
Saint Luke's-Roosevelt Hospital CenterNew York, New York  10019
Rheumatology Associates of Long IslandPort Jefferson Station, New York  11776
University of North CarolinaChapel Hill, North Carolina  27599
University of PennsylvaniaPhiladelphia, Pennsylvania  19104