Low-dose IL-2( Interleukin-2) Treatment in SLE

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic lupus erythematosus.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborator: Monash University
• Treatments: 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.