Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura (NCT02317133) | Clinical Trial Compass
CompletedNot Applicable
Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura
France100 participantsStarted 2015-02
Plain-language summary
The primary objective of this study is to search for evidence of quantitative or functional defects in plasma regulatory T cells (Tregs) in pediatric patients with Henoch Schönlein Purpura (HSP) as compared to a control population.
Who can participate
Age range
3 Years – 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.
General inclusion criteria for all sub-populations included in the study
* The child (with age- and comprehension-skill-appropriate information) and parents (or persons exercising parental authority) have been informed about the implementation of the study, its objectives, constraints and patient rights
* The child (depending on age) and parents (or persons exercising parental authority) have given their free and informed consent and signed the consent
* The patient must be insured or beneficiary of a health insurance plan
Inclusion criteria for population A: Henoch Schönlein purpura, acute episodes
* The diagnosis of Henoch Schönlein purpura was made by a physician according to the EULAR / PRES / PRINTO 2010 criteria (purpura predominantly on the lower limbs associated with one of the following criteria: abdominal pain, arthralgia or arthritis, kidney damage or suggestive histology (immune deposits dominated by Immunoglobulin A (IgA))
* The patient is not treated via immunosuppression (steroids or other immunosuppressive / biotherapy) and has not been treated like this for at least 15 days
Inclusion criteria for population B: Henoch Schönlein purpura in remission
* The diagnosis of Henoch Schönlein purpura was made by a physician according to the EULAR / PRES / PRINTO 2010 criteria
* The patient has has a Henoch Schönlein purpura episode in the past, and no longer has any symptoms of the disease
* The patient is not treated via immunosuppression (steroids or other immun…
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
1
Percentage of blood Tregs
Timeframe: Day 0
2
Absolute Treg count
Timeframe: Day 0
3
Presence / absence of functional abnormality of plasma Tregs