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

NCT04136106 | Unknown FDA Drug

• 1 other identifier: IL2Pro-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: IL-2

Non IL-2 group

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

Interventions

IL-2 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.

Low-dose IL-2 group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking Universtiy People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related 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 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.

  PMID: 27500725 RESULT

MeSH Terms

Conditions

Infections

Interventions

Interleukin-2

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Zhanguo Li, PhD,MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiali Chen, MD

CONTACT

+8618801206400; chenjiali0389@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: July 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: December 30, 2021
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)