The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases (SLE，pSS，JIA)

August 16, 2022 updated by: The First Hospital of Jilin University

The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis)

The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with rheumatic diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines.

Methods: Patients were divided into two groups. One received standard therapy, while another one administrate with low-does IL-2 plus standard therapy.

Study Type

Interventional

Enrollment (Actual)

46

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
    • Changchun/Jilin
      • Changchun, Changchun/Jilin, China, 130000
        • Sirui Yang

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

No older than 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age <18 years old
  2. meet the diagnostic criteria of disease classification
  3. HIV negative;Negative for Hepatitis B Virus and Hepatitis C Virus.

Exclusion Criteria:

  1. heart failure (cardiac function ≥ grade III NYHA)
  2. liver insufficiency (upper limit of normal range of transaminase > 2 times)
  3. renal insufficiency (creatinine clearance ≤30ml/min)
  4. acute or severe infections such as bacteremia and sepsis
  5. malignant tumor
  6. high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month;Rituximab, infliximab or other biological agents were used
  7. mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
  8. 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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recombinant Human Interleukin-2
Induced remission period,recombinant human IL-2(500,000 unit per square meter) infusions five days;Maintenance treatment period,recombinant human IL-2 infusions five days then once every two weeks for 6 months.
Drug: IL-2
Patients were received low dose recombinant human Interleukin-2
Other Names:
  • Recombinant Human Interleukin-2 for Injection
No Intervention: Traditional therapy
Patients were treated with glucocorticoid and/or immunosuppressor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in steroid dose and immunosuppressor dose at 1 year compared to control group
Time Frame: 1 year
The average daily doses of steroid and immunosuppressor per square meter was recorded
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Immunologic Impact of IL-2 Treatment
Time Frame: 1 month,3 month,6 month,1 year
Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.
1 month,3 month,6 month,1 year
Immunological Responses
Time Frame: 1 month,3 month,6 month,1 year
Enumeration of the number of subjects with a change in the absolute number of immune cells and serum cytokines in the peripheral blood
1 month,3 month,6 month,1 year
Change from baseline in SELENA SLEDAI Score
Time Frame: 1 month,3 month,6 month,1 year
Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. The higher the score represent the worse of the disease. The total score ranges from 0 to 105 points.
1 month,3 month,6 month,1 year
Change from baseline in EULAR SS disease activity index
Time Frame: 1 month,3 month,6 month,1 year
Low-activity (ESSDAI<5),moderate-activity (5≤ESSDAI≤13) ,high-activity (ESSDAI≥14) levels.
1 month,3 month,6 month,1 year
Incidence of adverse drug reactions
Time Frame: up to 1 year
Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.
up to 1 year

Collaborators and Investigators

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

Sponsor

The First Hospital of Jilin University

Investigators

  • Principal Investigator: Sirui Yang, MD and PhD, The First Hospital of Jilin University

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)

August 15, 2020

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20K013-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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