Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target (C5-MAG4)
June 25, 2024 updated by: Assistance Publique Hopitaux De Marseille
Pilot Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target. C5-MAG4 Study.
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Estimated)
66
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: healthy volunteers
|
Blood sampling will be taken for further analysis
|
|
Experimental: IgG4-RD patient
Patients suffering from Immunoglobulin G4-related disease (IgG4-RD).
|
Blood sampling will be taken for further analysis
|
|
Experimental: patient in remission
Patients suffering from Immunoglobulin G4-related disease (IgG4-RD) but in remission.
|
Blood sampling will be taken for further analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum C5a concentration
Time Frame: 24 months
|
The C5a concentration in the serum will be compared between of healthy volunteers and patients suffering from IG4-related disease
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
frequency of C5aR1+ monocytes among total monocytes
Time Frame: 24 months
|
The frequency of C5aR1+ monocytes among total monocytes will be compared between :
|
24 months
|
|
frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytes
Time Frame: 24 months
|
frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytesill be compared between :
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
April 30, 2027
Study Registration Dates
First Submitted
February 14, 2024
First Submitted That Met QC Criteria
February 14, 2024
First Posted (Actual)
February 21, 2024
Study Record Updates
Last Update Posted (Actual)
June 26, 2024
Last Update Submitted That Met QC Criteria
June 25, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCAPHM21_0433
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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