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

March 14, 2018 updated by: Zhanguo Li, Peking University People's Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Department of Rheumatology and Immunology, Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Interleukin-2
Interleukin-2 to treat activated SLE.
Drug: Interleukin-2
Patients receive low dose recombinant human Interleukin-2（HrIL-2）
Other Names:
  • Recombinant Human Interleukin-2,125Ala, SL Pharm
NO_INTERVENTION: Traditional therapy
Treat activated SLE with glucocorticoid or immunosuppressor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological Responses
Time Frame: week 0 and week 10
The increased intracellular factors which could reflect the organic immunity
week 0 and week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virus titers
Time Frame: week 0 and week 10
The reduced titers of virus in SLE patients
week 0 and week 10

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLEDAI Score
Time Frame: week 0 and week 10
Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change.
week 0 and week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Zhanguo Li, MD and PhD, Peking University Institute of Rheumatology and Immunology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 5, 2016

Primary Completion (ACTUAL)

December 16, 2016

Study Completion (ACTUAL)

August 30, 2017

Study Registration Dates

First Submitted

October 8, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (ESTIMATE)

October 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL-2-20160505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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