The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases

Recruiting

• Conditions: Autoimmune Diseases; Polyclonal Hypergammaglobulinemia

• Registration Number: NCT06054373
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Polyclonal hypergammaglobulinaemia is characterized by increased levels of immunoglobulins and is a common feature observed in various diseases such as autoimmune diseases, chronic infectious diseases or lymphoid hemopathy. Some autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis or Sjögren's syndrome are frequently associated with polyclonal hypergammaglobulinaemia. Recent data have suggested that the distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia may be disease-specific. However, isotype repartition in polyclonal hypergammaglobulinaemia remains poorly understood.

The investigators will investigate the distribution of immunoglobulin isotype in patients with autoimmune disease and polyclonal hypergammaglobulinaemia. Moreover, the investigators will evaluate the isotype repartition as predictor of lymphoma or monoclonal gammopathy among patients with autoimmune diseases.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-27
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-08
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• All adult patients > 18 years old
• patients with one of the following diseases: systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, autoimmune hepatitis, sarcoidosis or lymphoma.

Exclusion Criteria

• Age < 18 years;
• chronic viral hepatitis;
• HIV infection, syphilis,
• tuberculosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
distribution of immunoglobulin isotypes	one day	distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia associated with autoimmune and systemic diseases (systemic lupus erythematosus, rheumatoid arthritis, Gougerot-Sjögren syndrome, sarcoidosis)

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France