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

The First Hospital of Jilin University46 enrolled

Overview

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).

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

IL-2DRUG

Patients were received low dose recombinant human Interleukin-2

Eligibility

Sex: ALLMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sirui Yang

Changchun, Changchun/Jilin, China

Outcomes

Primary Outcomes

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

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

Time frame: 1 year

Secondary Outcomes

The Immunologic Impact of IL-2 Treatment

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

Time frame: 1 month,3 month,6 month,1 year

Immunological Responses

Enumeration of the number of subjects with a change in the absolute number of immune cells and serum cytokines in the peripheral blood

Time frame: 1 month,3 month,6 month,1 year

Change from baseline in SELENA SLEDAI Score

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.

Time frame: 1 month,3 month,6 month,1 year

Change from baseline in EULAR SS disease activity index

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

Time frame: 1 month,3 month,6 month,1 year

Incidence of adverse drug reactions

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

Time frame: up to 1 year

Data from ClinicalTrials.gov

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