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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

All patients are followed at 1 year.

Inclusion 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

- 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


- No hepatic dysfunction

- No tumors of the liver

Renal: See Disease Characteristics


- 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

- 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


- 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:


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


United States: Federal Government

Study ID:




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



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