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

Peking University

Status: Unknown

Conditions: Infection

Treatments: Drug: IL-2

Study type: Observational

Funder types: Other

Identifiers

NCT04136106

IL2Pro-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Low-dose IL-2 group

Description:

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.

Treatment:

Drug: IL-2

Non IL-2 group

Description:

Patients in this group were only treated with corticosteroid and immunosuppressor,