NCT04136106

The Incidence of Infection in Treatment of Low-dose IL-2 of SLE Patients

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
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection

Interventions

Type	Name	Description
DRUG	IL-2	IL-2 is a medicine which can use in autoimmune disease, infection or cancer with different dose. Low-dose IL-2 preferentially used in autoimmune disease, such as SLE. Our enrolled SLE patients will divided into two groups depend on whether use IL-2 or not, combined with corticosteroid and immunosuppressor.

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-11-01
• Completion: 2021-12-30
• First posted: 2019-10-23
• Last updated: 2019-10-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study