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NCT Number: NCT06054373

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. distribution of immunoglobulin isotypes

    Time frame: one day

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

Study contacts

Contact information is provided by the study sponsor or research team.

Valéry Salle, MD

CONTACT

[email protected]

03 22 66 82 30

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Binding site

Registry information

Acronym: ISOHYPE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2023
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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