A Prospective Cohort Study of IgG4RD in China

Cohort Study of Patients With IgG4-Related Disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01670695

Enrollment

1000

Registered

2012-08-22

Start date

2012-01-31

Completion date

2032-01-31

Last updated

2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgG4-related Disease

Keywords

IgG4-related disease, IgG4-RD

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical Response	6 months	Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.

Countries

China

Contacts

Primary ContactHua Chen, MD

chen77hua@gmail.com86-10-69158797

Outcome results