Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT04136106
Status:
UNKNOWN
Last Update Posted:
2019-10-23
First Post:
2019-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Incidence of Infection in Treatment of Low-dose IL-2 of SLE Patients
Sponsor:
Peking University People's Hospital
Organization:
Study Overview
Official Title:
The Incidence of Infection in Treatment of Low-dose IL-2 Combined With Corticosteroid and Immunosuppressor in SLE Patients- a Multi-center Prospective Study
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IL-2 is a pleiotropic cytokine which can regulate or stimulate the differentiation and function of CD4+, CD8+ and NK cells. An opened-labelled trial and a retrospective study have indicated the incidence of infection is lower in the treatment of low-dose IL-2 combined with corticosteroid and immunosuppressor. We are going to conduct a multi-center prospective observational study to verify the above results.
Detailed Description:
We are going to conduct a multi-center prospective observational study, and plan to enroll 500 SLE patients. Low-dose IL-2 is defined as 100IU IL-2 injected subcutaneously every other day for two weeks, followed by two-week break as one treatment cycle, and at least three weeks.There will be 250 patients in low-dose IL-2 group which treat with IL-2 combined with steroid and immunosuppressor. Non-IL-2 group is only treat with steroid and immunosuppressor. These patients are followed by every one month until get infected, otherwise, patients will be followed for two years. We focus on the type, positive microorganisms, grade and treatment of infection. Then, we will compare the differences of above parameters between these two groups.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: