Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Blood sampling

    Procedure/Surgery

    Blood sampling will be taken for further analysis

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: IgG4-RD patientExperimental treatment 1 intervention
Group B: patient in remissionExperimental treatment 1 intervention
Group C: healthy volunteersOther 1 intervention

Trial outcomes

Primary outcomes

1

Serum C5a concentration

The C5a concentration in the serum will be compared between of healthy volunteers and patients suffering from IG4-related disease

Time frame
24 months

Secondary outcomes

1

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

Time frame
24 months
2

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

Time frame
24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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