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

Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04136106
• Other study ID #: IL2Pro-01
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2019
• Source: Peking University People's Hospital
• Contact: Jiali Chen, MD
• Phone: +8618801206400
• Email: chenjiali0389[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

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.

Locations

Country	Name	City	State
China	Peking Universtiy People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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 tre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of infection of two groups	Infection is confirmed by art least one infectious specialist or rheumatologist, by means of clinical symptoms, positive microorganisms culture, response to antibiotic therapy.	2 years