ABOUT THIS STUDY
For SLE Subjects:
- SLE patients who exhibit ongoing disease activity by SLEDAI greater or equal to 4.
- SLE patients whose disease activity is controlled by administration of corticosteroids, most commonly, at least 10 mg/day of prednisone.
- 18 years of age or older.
- Updated vaccinations prior to study entry.
- Use of effective contraception for male patients before, during and up to 12 weeks after sirolimus therapy.
For Healthy Control Subjects:
- 18 years of age or older
- Must be matched with one of the SLE patients enrolled in the study by age, gender and ethnic origin
- Must not have any acute or chronic illness.
For SLE Subjects:
- Patients who are pregnant.
- Patients with allergy or intolerance to sirolimus.
- Patients with life-threatening manifestations of SLE.
- Patients with proteinuria exceeding 500 mg/24 h or urine protein/creatine ratio >0.5.
- Patients with total cholesterol > 300 mg/dl or triglyceride > 400 mg.dl will be
- Patients with acute infection requiring antibiotics.
- Patients on sirolimus who develop infections and require intravenous antibiotics and
fail to show clinical improvement in 5 days.
- Patients concurrently undergoing B cell-depleting therapy, cyclophosphamide,
cyclosporine, and tacrolimus.
- Patients who have received investigational biologic B-cell depleting products within
one year of study initiation.
- Patients with a history of chronic viral infections (e.g., HIV, hepatitis B, hepatitis
C) or with a history of a malignancy (except non-melanoma skin cancer).
- Due to interference with sirolimus metabolism, subjects will not be allowed to receive
concomitant rifampin, ketoconazole,voriconazole, itraconazole, erythromycin, or
clarithromycin during the study.
- Patients with any type of interstitial lung disease.
For Healthy control Subjects:
- Subjects who are pregnant.
- Subjects with any acute or chronic illness.
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