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NCT00779194 · ClinicalTrials.gov registry record · Phase 2
Prospective Study of Rapamycin for the Treatment of SLE
A Phase 2 study, sponsored by State University of New York - Upstate Medical University.
- Completed
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
NCT00779194: Completed Phase 2 study, sponsored by State University of New York - Upstate Medical University.
NCT00779194 is a Phase 2 study that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 99 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00779194, a Phase 2 study, has completed, sponsored by State University of New York - Upstate Medical University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
Study 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 by a dysfunction of the immune system. The drugs currently used for the treatment of SLE are only partially effective and carry significant risks for side-effects. Patients that were resistant or intolerant to conventional medication have been effectively treated with Rapamycin and were able to decrease the amount of prednisone they needed. The purpose of this study is to prospectively determine the therapeutic efficacy and mechanism of action of Rapamune in patients with SLE. Healthy subjects not receiving Rapamune will be asked to donate blood to serve as controls only for immunobiological outcomes. As part of the research effort to understand the reason for the variations in the effects of treatment drugs by different individuals, a sub-study of the DNA makeup of subjects enrolled in the trial will also be done. The purpose of the sub-study is to possibly determine whether different responses to the drugs used to treat SLE have a correlation with the differences in the genetic makeup of the subjects.
Primary Outcome
The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and The British Isles Lupus Assessment Group (BILAG) are clinical tools for assessing disease activity in lupus erythematosus patients. These indices play a central role as core determinants in SLE Responder Index. SLEDAI, comprising 24 items, quantifies disease activity on a scale of 0 to 105. Higher scores indicate more severe disease activity, reflecting cumulative impact of clinical and laboratory variables. BILAG, a comprehe
Interventions
- DRUG Rapamycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2008-10 |
| Est. Completion | 2015-12-16 |
| Phase | Phase 2 |
What the finished NCT00779194 record still lists
NCT00779194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 1 intervention - of which Rapamycin is the first listed.
NCT00779194 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00779194 about?
NCT00779194 is a clinical study titled "Prospective Study of Rapamycin for the Treatment of SLE". 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 by a dysfunction of the immune system. The drugs currently used for the treatment of SLE are only p...
What is the current status of trial NCT00779194?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2008-10. Estimated completion is 2015-12-16.
What interventions are being tested in trial NCT00779194?
The interventions under investigation include: Rapamycin (DRUG).
Who is sponsoring clinical trial NCT00779194?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00779194's enrollment target sits among peer trials
99 738th of 2000 higher than 1,258 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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