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

Peking University

Status

Completed

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Interleukin-2

Study type

Interventional

Funder types

Other

Identifiers

NCT02932137

IL-2-20160505

Details and patient eligibility

About

The objective of this clinical study is to evaluate the potential effect of anti-infection of low-does IL-2 in patients with SLE.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.