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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
Sponsor:
Information provided by (Responsible Party):
Zhanguo Li, Peking University People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Interleukin-2 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Interleukin-2
Interleukin-2 to treat activated SLE.
 Drug: Interleukin-2
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.


Outcome Measures
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Primary Outcome Measures :
  1. Immunological Responses [ Time Frame: week 0 and week 10 ]
    The increased intracellular factors which could reflect the organic immunity


Secondary Outcome Measures :
  1. Virus titers [ Time Frame: week 0 and week 10 ]
    The reduced titers of virus in SLE patients


Other Outcome Measures:
  1. SLEDAI Score [ Time Frame: week 0 and week 10 ]
    Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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


Locations
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China, Beijing
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Zhanguo Li, MD and PhD Peking University Institute of Rheumatology and Immunology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhanguo Li, Professor and chief of department of rheumatology and immunology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02932137    
Other Study ID Numbers: IL-2-20160505
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zhanguo Li, Peking University People's Hospital:
SLE,IL-2
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Interleukin-2
Antineoplastic Agents
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs