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

Study Overview
=================
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.

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)

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: IL-2


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: One group patients were treated with IL-2 and another group patients were treated with routine therapy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant Human Interleukin-2<br>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<br>* Patients were received low dose recombinant human Interleukin-2<br>* Other names: Recombinant Human Interleukin-2 for Injection;|
| No Intervention: Traditional therapy<br>Patients were treated with glucocorticoid and/or immunosuppressor. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Immunologic Impact of IL-2 Treatment | Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres. | 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 | 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. | 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. | 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. | up to 1 year |