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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    46
  • sponsor
    The First Hospital of Jilin University
Updated on 22 October 2021
interleukin-2
sjogren's syndrome
arthritis
rheumatic diseases
lupus
Accepts healthy volunteers

Summary

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

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.

Details
Condition Systemic Lupus Erythematosus, Connective Tissue Diseases, SYSTEMIC LUPUS ERYTHEMATOSUS, Autoimmune Disease, Dermatomyositis (Connective Tissue Disease), Autoimmune disease, CONNECTIVE TISSUE DISEASE
Treatment IL-2
Clinical Study IdentifierNCT04397107
SponsorThe First Hospital of Jilin University
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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