About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Blood sampling
Procedure/SurgeryBlood sampling will be taken for further analysis
Treatment groups
Trial outcomes
Primary outcomes
Serum C5a concentration
The C5a concentration in the serum will be compared between of healthy volunteers and patients suffering from IG4-related disease
Secondary outcomes
frequency of C5aR1+ monocytes among total monocytes
The frequency of C5aR1+ monocytes among total monocytes will be compared between : * patients suffering from IG4-related disease and healthy volunteers * patients suffering from IG4-related disease and patients in remission
frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytes
frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytesill be compared between : * patients suffering from IG4-related disease and healthy volunteers * patients suffering from IG4-related disease and patients in remission
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: