CompletedNot Applicable

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

China46 participantsStarted 2020-08-15

Plain-language 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).

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 year

Trial details

NCT IDNCT04397107

SponsorThe First Hospital of Jilin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-31

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials