Clinical trial NCT04136106: The Incidence of Infection in Treatment of Low-dose IL-2 of SLE Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Depending on the incidence of infection in our retrospective study, Low-dose IL-2 group was 14.1%, non-IL-2 group was 25.2%. α was 0.05, β was 0.2, After the calculation of sample size, with the addition of about 20% patients for loss of follow-up, we plan to enroll 500 patients, and 250 patients in every groups equally.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of infection of two groups
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Universtiy People's Hospital
state: Beijing
Study officials:
affiliation: Department of Rheumatology and Immunology, Peking University People's Hospital
name: Zhanguo Li, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: He J, Zhang X, Wei Y, Sun X, Chen Y, Deng J, Jin Y, Gan Y, Hu X, Jia R, Xu C, Hou Z, Leong YA, Zhu L, Feng J, An Y, Jia Y, Li C, Liu X, Ye H, Ren L, Li R, Yao H, Li Y, Chen S, Zhang X, Su Y, Guo J, Shen N, Morand EF, Yu D, Li Z. Low-dose interleukin-2 treatment selectively modulates CD4(+) T cell subsets in patients with systemic lupus erythematosus. Nat Med. 2016 Sep;22(9):991-3. doi: 10.1038/nm.4148. Epub 2016 Aug 8.