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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932137
• Other study ID #: IL-2-20160505
• Status: Completed
• Phase: N/A
• First received: October 8, 2016
• Last updated: March 14, 2018
• Start date: May 5, 2016
• Est. completion date: August 30, 2017

Study information

• Verified date: March 2018
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2017
• Est. primary completion date: December 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Interleukin-2
Patients receive low dose recombinant human Interleukin-2(HrIL-2)

Locations

Country	Name	City	State
China	Department of Rheumatology and Immunology, Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SLEDAI Score	Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change.	week 0 and week 10
Primary	Immunological Responses	The increased intracellular factors which could reflect the organic immunity	week 0 and week 10
Secondary	Virus titers	The reduced titers of virus in SLE patients	week 0 and week 10