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

NCT06270524 | Not Yet Recruiting

• 1 other identifier: RCAPHM21_0433
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Immunoglobulin G4-Related Disease

Outcome Measures

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

  24 months

Secondary Outcomes (2)

• frequency of C5aR1+ monocytes among total monocytes

  24 months

• frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytes

  24 months

Study Arms (3)

IgG4-RD patient

EXPERIMENTAL

Patients suffering from Immunoglobulin G4-related disease (IgG4-RD).

Procedure: Blood sampling

patient in remission

EXPERIMENTAL

Patients suffering from Immunoglobulin G4-related disease (IgG4-RD) but in remission.

Procedure: Blood sampling

healthy volunteers

OTHER

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

Blood sampling will be taken for further analysis

IgG4-RD patient; healthy volunteers; patient in remission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• \- age \> 18
• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 26, 2024

Record last verified: 2024-06