A Prospective Cohort Study of IgG4RD in China

Recruiting

• Conditions: IgG4-related Disease

• Registration Number: NCT01670695
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-22
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-11
• Primary Completion: 2032-01
• Study Completion: 2032-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Deptment of Rheumatology, Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China