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

• Conditions: Infection
• Interventions: Drug: IL-2

• Registration Number: NCT04136106
• Lead Sponsor: Peking University People's Hospital

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 Timeline

• Study Start: 2019-07-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-21
• Last Update Submitted: 2019-10-21
• Study First Posted: 2019-10-23
• Last Update Posted: 2019-10-23
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• SLE patients diagnosed by the ACR Criteria of 1987;
• Treated with low-dose IL-2, corticosteroid and immunosuppressor for SLE.
• Consent to participate in this study.
• Regular follow-up for at least 2 years.

Exclusion Criteria

• Other autoimmune disease;
• Without treatment of low-dose IL-2, corticosteroid and immunosuppressor for SLE.
• Mental disorder without regular or specific treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low-dose IL-2 group	IL-2	Patients in this group were treated with low-dose IL-2 combined with corticosteroid and immunosuppressor, and low-dose IL-2 is defined as 100IU subcutaneously every other day for two weeks, followed by two-week break, as one treatment cycle, and at least three cycles.

Primary Outcome Measures

Name	Time	Method
The incidence of infection of two groups	2 years	Infection is confirmed by art least one infectious specialist or rheumatologist, by means of clinical symptoms, positive microorganisms culture, response to antibiotic therapy.

Trial Locations

Locations (1)

Peking Universtiy People's Hospital; 🇨🇳 Beijing, Beijing, China