Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target (NCT06270524) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target
66 participantsStarted 2024-09-01
Plain-language summary
This is a monocentric, comparative, cross-sectional, case-control study seeking to identify abnormalities of the C5a-C5aR1 axis between a population of patients with active IgG4-associated disease (MAG4) and two control groups: healthy subjects without MAG4 and patients with MAG4 in remission.
Who can participate
Age range
18 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 for patients suffering from IG4-related disease and patients in remission :
* age \> 18
* diagnosis of IgG4-associated disease according to ACR/EULAR 2019 classification criteria (4,5) with a score ≥20.
* disease activity score (IgG4-RD Responder Index) ≥2 in at least one affected organ
Exclusion Criteria for patients suffering from IG4-related disease and patients in remission :
* presence of a differential diagnosis ("IgG4-RD mimicker") or exclusion criterion according to ACR/EULAR 2019 classification criteria (4,5).
* systemic corticosteroid treatment ≥5 mg/day ongoing or \< 1 month ; Study C5-MAG4\_RCAPHM21\_0433 Protocol Version 1.1 of 16/01/2024 Page 15 of 41
* immunosuppressive therapy ongoing or \< 3 months ;
* current biotherapy treatment or \< 6 months;
* absence of signed informed consent;
* absence of affiliation to a Social Security scheme.
* patient participating in an ongoing therapeutic trial ;
* any condition which, in the opinion of the investigator, could influence the results of the study.
Inclusion criteria for healthy volunteers :
\- age \> 18
Exclusion criteria for healthy volunteers :
* infectious episode (temperature \>38°C, flu-like signs) in the 30 days prior to inclusion;
* known inflammatory (including IG4-related disease) or autoimmune pathology;
* treatment with corticosteroids in progress or taken in the month prior to sampling, or immunosuppressants in progress or taken in the 3 months prior to sampling, or biotherapy…
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.