Back to resultsAnti-infection of Low-does IL-2 in SLE
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Interleukin-2
Sponsored by
About this trial
This is an interventional prevention trial for Systemic Lupus Erythematosus focused on measuring SLE,IL-2
Eligibility Criteria
Inclusion Criteria:
- Meet the American College of Rheumatology criteria for the diagnosis of SLE.
- Under standard treatment (≥ 2 months) at the time of inclusion
- Background treatment failed to control flares or to permit prednisone tapering
- With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria>0.5g/day), neuropsychiatric SLE.
- Positive for at least one of the following laboratory tests: ANA>1:160, anti-dsDNA, immunoglobulin>20g/L, decreased C3 or C4, leukopenia<3×10^9/L, thrombocytopenia<100×10^9/L;
- SLE disease activity index(SLEDAI) ≥ 8.
- Negative HIV test.
- Negative for hepatitis B and C virus.
- Written informed consent form.
Exclusion Criteria:
- Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases> 3N) )
- Serious infection such as bacteremia, sepsis;
- Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
- High-dose steroid pulse therapy (>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months.
- History of administration of rituximab or other biologics;
- Purified protein derivative (tuberculin) >10mm
- Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
- Inability to comply with IL-2 treatment regimen.
Sites / Locations
- Department of Rheumatology and Immunology, Peking University People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interleukin-2
Traditional therapy
Arm Description
Interleukin-2 to treat activated SLE.
Treat activated SLE with glucocorticoid or immunosuppressor.
Outcomes
Primary Outcome Measures
Immunological Responses
The increased intracellular factors which could reflect the organic immunity
Secondary Outcome Measures
Virus titers
The reduced titers of virus in SLE patients
Full Information
NCT ID
NCT02932137
First Posted
October 8, 2016
Last Updated
March 14, 2018
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02932137
Brief Title
Anti-infection of Low-does IL-2 in SLE
Official Title
Potential Effect of Anti-infection by Low-dose IL-2 in Treatment of SLE
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 5, 2016 (Actual)
Primary Completion Date
December 16, 2016 (Actual)
Study Completion Date
August 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this clinical study is to evaluate the potential effect of anti-infection of low-does IL-2 in patients with SLE.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
SLE,IL-2
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interleukin-2
Arm Type
Experimental
Arm Description
Interleukin-2 to treat activated SLE.
Arm Title
Traditional therapy
Arm Type
No Intervention
Arm Description
Treat activated SLE with glucocorticoid or immunosuppressor.
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Other Intervention Name(s)
Recombinant Human Interleukin-2,125Ala, SL Pharm
Intervention Description
Patients receive low dose recombinant human Interleukin-2（HrIL-2）
Primary Outcome Measure Information:
Title
Immunological Responses
Description
The increased intracellular factors which could reflect the organic immunity
Time Frame
week 0 and week 10
Secondary Outcome Measure Information:
Title
Virus titers
Description
The reduced titers of virus in SLE patients
Time Frame
week 0 and week 10
Other Pre-specified Outcome Measures:
Title
SLEDAI Score
Description
Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change.
Time Frame
week 0 and week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the American College of Rheumatology criteria for the diagnosis of SLE.
Under standard treatment (≥ 2 months) at the time of inclusion
Background treatment failed to control flares or to permit prednisone tapering
With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria>0.5g/day), neuropsychiatric SLE.
Positive for at least one of the following laboratory tests: ANA>1:160, anti-dsDNA, immunoglobulin>20g/L, decreased C3 or C4, leukopenia<3×10^9/L, thrombocytopenia<100×10^9/L;
SLE disease activity index(SLEDAI) ≥ 8.
Negative HIV test.
Negative for hepatitis B and C virus.
Written informed consent form.
Exclusion Criteria:
Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases> 3N) )
Serious infection such as bacteremia, sepsis;
Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
High-dose steroid pulse therapy (>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months.
History of administration of rituximab or other biologics;
Purified protein derivative (tuberculin) >10mm
Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
Inability to comply with IL-2 treatment regimen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanguo Li, MD and PhD
Organizational Affiliation
Peking University Institute of Rheumatology and Immunology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology and Immunology, Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33687069
Citation
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.
Results Reference
derived
PubMed Identifier
31537547
Citation
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.
Results Reference
derived
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Anti-infection of Low-does IL-2 in SLE
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