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

Not Applicable

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: IL-2

• Registration Number: NCT04397107
• Lead Sponsor: The First Hospital of Jilin University

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).

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 Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-21
• Study Start: 2020-08-15
• Primary Completion: 2022-05-31
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Recombinant Human Interleukin-2	IL-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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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.
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.
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.

Trial Locations

Locations (1)

Sirui Yang; 🇨🇳 Changchun, Changchun/Jilin, China