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

NCT ID: NCT04136106

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-12-30

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.

Conditions

Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Low-dose IL-2 group

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.

IL-2

Intervention Type: DRUG

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.

Non IL-2 group

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

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhanguo Li, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Department of Rheumatology and Immunology, Peking University People's Hospital

Locations

Peking Universtiy People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiali Chen, MD

Role: CONTACT

chenjiali0389@163.com

+8618801206400

Facility Contacts

Jiali Chen, MD

Role: primary

chenjiali0389@163.com

+8618801206400

References

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.

Reference Type: RESULT

PMID: 27500725 (View on PubMed)

Other Identifiers

IL2Pro-01

Identifier Type: -

Identifier Source: org_study_id