Status:
COMPLETED
Prospective Study of Rapamycin for the Treatment of SLE
Lead Sponsor:
State University of New York - Upstate Medical University
Collaborating Sponsors:
Pfizer
Conditions:
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown origin. It involves multiple organs including the joints, skin, kidneys and central nervous system. The disease process is caused...
Detailed Description
43 SLE subjects and 56 healthy controls are being recruited. The study will last 1 year with 9 study visits from day 0 to day 360. The healthy controls only need to donate blood once. The study drug,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2015
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00779194
Start Date
October 1 2008
End Date
December 16 2015
Last Update
June 12 2024
Active Locations (1)
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1
SUNY Upstate Medical University
Syracuse, New York, United States, 13210