Systemic Lupus Erythematosus
Conditions
Keywords
SLE,IL-2
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.
Interventions
DRUGInterleukin-2
Patients receive low dose recombinant human Interleukin-2（HrIL-2）
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunological Responses | week 0 and week 10 | The increased intracellular factors which could reflect the organic immunity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Virus titers | week 0 and week 10 | The reduced titers of virus in SLE patients |
Other
| Measure | Time frame | Description |
|---|---|---|
| SLEDAI Score | week 0 and week 10 | Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. |
Countries
China
Outcome results
None listed