A Prospective Cohort Study of IgG4RD in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2032-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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IgG4-related Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IgG4-RD

Patients with IgG4-RD, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis (Mikulicz disease and Küttner's tumor), inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No