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

Sponsor
The First Hospital of Jilin University (Other)
Overall Status
Completed
CT.gov ID
NCT04397107
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
22.5
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
One group patients were treated with IL-2 and another group patients were treated with routine therapy.One group patients were treated with IL-2 and another group patients were treated with routine therapy.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis)
Actual Study Start Date :
Aug 15, 2020
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in steroid dose and immunosuppressor dose at 1 year compared to control group [1 year]

      The average daily doses of steroid and immunosuppressor per square meter was recorded

    Secondary Outcome Measures

    1. The Immunologic Impact of IL-2 Treatment [1 month,3 month,6 month,1 year]

      Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.

    2. Immunological Responses [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

    3. Change from baseline in SELENA SLEDAI Score [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.

    4. Change from baseline in EULAR SS disease activity index [1 month,3 month,6 month,1 year]

      Low-activity (ESSDAI<5),moderate-activity (5≤ESSDAI≤13) ,high-activity (ESSDAI≥14) levels.

    5. Incidence of adverse drug reactions [up to 1 year]

      Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sirui Yang Changchun Changchun/Jilin China 130000

    Sponsors and Collaborators

    • The First Hospital of Jilin University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The First Hospital of Jilin University
    ClinicalTrials.gov Identifier:
    NCT04397107
    Other Study ID Numbers:
    • 20K013-001
    First Posted:
    May 21, 2020
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rheumatic Diseases
    Lupus Erythematosus, Systemic
    Collagen Diseases
    Aldesleukin
    Interleukin-2

    Study Results

    No Results Posted as of Aug 18, 2022