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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT00779194
Eligibility Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
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 excluded.
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00779194
Study Brief:
Protocol Section:
NCT00779194