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The objective of this clinical study is to evaluate the potential effect of anti-infection of low-does IL-2 in patients with SLE.
Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs.Many feel that glucocorticoid and immunosuppressor are the standard therapy for patients with SLE. While it can improve the risk of infection among SLE patients. A novel therapy to treat SLE with low-does IL-2 has been identified recently. IL-2 also used to against some virus infect. So we hypothesized that low-dose IL-2 could reduce risk of infection in SLE patients.
Methods: A total of SLE patients (n=30) were divided into two groups randomly. One received standard therapy, while another one administrate with low-does IL-2 plus standard therapy.Each patient will be treated with low-dose IL-2. The end points are clinical and immunologic response.
Expected Results: This trail wlii provide both clinical and basic profe that low-dose IL-2 plus standard therapy have lower infection risk in SLE patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interleukin-2 | Experimental | Interleukin-2 to treat activated SLE. |
|
| Traditional therapy | No Intervention | Treat activated SLE with glucocorticoid or immunosuppressor. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interleukin-2 | Drug | Patients receive low dose recombinant human Interleukin-2(HrIL-2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunological Responses | The increased intracellular factors which could reflect the organic immunity | week 0 and week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Virus titers | The reduced titers of virus in SLE patients | week 0 and week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| SLEDAI Score | Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. | week 0 and week 10 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhanguo Li, MD and PhD | Peking University Institute of Rheumatology and Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology and Immunology, Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. | |
| 31537547 | Derived | He J, Zhang R, Shao M, Zhao X, Miao M, Chen J, Liu J, Zhang X, Zhang X, Jin Y, Wang Y, Zhang S, Zhu L, Jacob A, Jia R, You X, Li X, Li C, Zhou Y, Yang Y, Ye H, Liu Y, Su Y, Shen N, Alexander J, Guo J, Ambrus J, Lin X, Yu D, Sun X, Li Z. Efficacy and safety of low-dose IL-2 in the treatment of systemic lupus erythematosus: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2020 Jan;79(1):141-149. doi: 10.1136/annrheumdis-2019-215396. Epub 2019 Sep 19. |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |