Overview

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

Status:
Completed
Trial end date:
2017-08-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University People's Hospital
Treatments:
Glucocorticoids
Interleukin-2
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.