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A Prospective Cohort Study of IgG4RD in China

A Prospective Cohort Study of IgG4RD in China

Recruiting
18-75 years
All
Phase N/A

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Overview

This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.

Description

Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration.

In this study, patients with IgG4-RD will be investigated, including clinical presentation, laboratory findings and imaging study. All patients will be treated by standard care and follow-uped for at least 6 months.

Eligibility

Inclusion Criteria:

  • Males and females
  • Age 18-75 years old with informed consent
  • Patients with IgG4-RD:
    1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
    2. elevated serum IgG4 (>1.35 g/L)
    3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
    4. exclusion of other diseases.

Exclusion Criteria:

  • Females planning to bear a child recently or with childbearing potential
  • Concurrent severe and/or uncontrolled and/or unstable diseases
  • Patient with malignancy

Study details
    IgG4-related Disease

NCT01670695

Peking Union Medical College Hospital

26 January 2024

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