Anti-infection of Low-does IL-2 in SLE
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|ClinicalTrials.gov Identifier: NCT02932137|
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: Interleukin-2||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Potential Effect of Anti-infection by Low-dose IL-2 in Treatment of SLE|
|Actual Study Start Date :||May 5, 2016|
|Actual Primary Completion Date :||December 16, 2016|
|Actual Study Completion Date :||August 30, 2017|
Interleukin-2 to treat activated SLE.
Patients receive low dose recombinant human Interleukin-2（HrIL-2）
Other Name: Recombinant Human Interleukin-2,125Ala, SL Pharm
No Intervention: Traditional therapy
Treat activated SLE with glucocorticoid or immunosuppressor.
- Immunological Responses [ Time Frame: week 0 and week 10 ]The increased intracellular factors which could reflect the organic immunity
- Virus titers [ Time Frame: week 0 and week 10 ]The reduced titers of virus in SLE patients
- SLEDAI Score [ Time Frame: week 0 and week 10 ]Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932137
|Department of Rheumatology and Immunology, Peking University People's Hospital|
|Beijing, Beijing, China, 100044|
|Principal Investigator:||Zhanguo Li, MD and PhD||Peking University Institute of Rheumatology and Immunology|