Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling.
- Who it may be relevant to
- Registry conditions: Immunoglobulin G4-Related Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target. C5-MAG4 Study.
Overview
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.
Detailed description
IgG4-associated disease is a rare fibrosing and inflammatory disorder whose pathophysiology remains poorly understood. Activation of certain monocyte/macrophage populations (in particular M2-type macrophages) has been shown to be involved during the course of the disease. The mechanisms behind this monocyte/macrophage activation are not known. Expression of the C5aR receptor on the surface of these populations, and preliminary findings of elevated C5a in these patients, suggest a potential role for this C5a-C5aR axis. Demonstration of the involvement of this pathway would open a path to therapeutic perspetives (C5aR inhibitors) for these patients, who frequently suffer from cortico-dependence and relapses. The aim of this research is to use healthcare technologies to identify cellular and molecular therapeutic targets in the context of the IgG4-associated disease
Interventions
- Procedure Blood sampling
Blood sampling will be taken for further analysis
Primary outcome measures
- Serum C5a concentration [Time frame: 24 months]
Secondary outcome measures (2)
- frequency of C5aR1+ monocytes among total monocytes [Time frame: 24 months]
- frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytes [Time frame: 24 months]
Eligibility criteria
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 in the 6 months prior to sampling;
- absence of signed informed consent;
- absence of affiliation to a Social Security scheme;
- persons taking part in an ongoing therapeutic trial;
- any condition which, in the opinion of the investigator, could influence the results of the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06270524 · RCAPHM21_0433