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 range18 Years
SexALL
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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…