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NCT Number: NCT04397107

The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases

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).

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sirui Yang

Changchun, Changchun/Jilin, 130000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • heart failure (cardiac function ≥ grade III NYHA)
  • liver insufficiency (upper limit of normal range of transaminase > 2 times)
  • renal insufficiency (creatinine clearance ≤30ml/min)
  • acute or severe infections such as bacteremia and sepsis
  • malignant tumor
  • high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month;Rituximab, infliximab or other biological agents were used
  • mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
  • Inability to comply with IL-2 treatment regimen.

Treatment and study plan

IL-2

Drug

Patients were received low dose recombinant human Interleukin-2

Other names: Recombinant Human Interleukin-2 for Injection

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study 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)

Acronym: SLE，pSS，JIA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 21, 2020
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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