Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT00006133
Eligibility 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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
0 Years
Study:
NCT00006133
Study Brief:
Protocol Section:
NCT00006133