Anti-infection of Low-does IL-2 in SLE

Study Overview
=================
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.

Official Title
-----------------
Potential Effect of Anti-infection by Low-dose IL-2 in Treatment of SLE

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: Interleukin-2


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interleukin-2<br>Interleukin-2 to treat activated SLE. | Drug: Interleukin-2<br>* Patients receive low dose recombinant human Interleukin-2（HrIL-2）<br>* Other names: Recombinant Human Interleukin-2,125Ala, SL Pharm;|
| No Intervention: Traditional therapy<br>Treat activated SLE with glucocorticoid or immunosuppressor. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological Responses | The increased intracellular factors which could reflect the organic immunity | week 0 and week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virus titers | The reduced titers of virus in SLE patients | week 0 and week 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SLE,IL-2