Ro60 Expression in Macrophages in Sjogren's Disease (NCT06324968) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Ro60 Expression in Macrophages in Sjogren's Disease
France20 participantsStarted 2024-02-09
Plain-language summary
Context: The Ro60 protein associates with YRNAs (or RNYs) to form the RoRNP complex, which regulates RNA surveillance and maturation. It is hypothesized that its impairment by nuclear penetration of the anti-Ro60 autoantibodies, would deregulate the anti-inflammatory response in monocytes/macrophages (Mo/Mp) in patients with Sjögren's disease (SD).
Who can participate
Age range
18 Years – 75 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:
* Patients with SSp Subjects aged between 18 and 75, without chronic disease; Subject meeting the classification criteria for SSp; Subject with positive anti-SSA serology; French-speaking subject able to give written consent; Subject affiliated to the Sécurité Sociale or an equivalent scheme; Subject willing to have blood samples taken;
* Control subjects Subjects aged between 18 and 75, without chronic disease and not meeting SSp classification criteria; Subject who understands and speaks French and is able to give written consent; Subject affiliated to the French Social Security system or an equivalent scheme; Subject willing to have blood taken;
Exclusion Criteria:
* Subject receiving current anti-inflammatory treatment (e.g. corticosteroid therapy, non-steroidal anti-inflammatory drugs) or a regimen of more than 1 month within the last 3 months;
* Subject undergoing biotherapy or cytoreductive treatment;
* Subjects with positive serologies for human immunodeficiency virus (HIV), viral hepatitis B virus (HBV) and viral hepatitis C virus (HCV) in the 3 months preceding the inclusion visit;
* Protected persons as defined in articles of the French Public Health Code.
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.