CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 99 enrolled
Drug / intervention
Rapamycindrug
Likely dose
Rapamycin 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00779194
NCT00779194Phase 2Completed

Prospective Study of Rapamycin for the Treatment of SLE

State University of New York - Upstate Medical University·interventional·Posted Oct 24, 2008·Updated Jun 12, 2024

In Brief

A Phase 2 clinical trial evaluating Rapamycin for Systemic Lupus Erythematosus (SLE). Completed, enrolled 99 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 24, 2008
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2015
Study CompletionDec 16, 2015
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 17.7 years ago

Interventions

Rapamycindrug

Rapamycin, is given to this group at a starting dose of 2 mg/day.