A Prospective Cohort Study of IgG4RD in China

IgG4-related Disease Clinical Trial

Official title:

Cohort Study of Patients With IgG4-Related Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01670695
• Other study ID #: IgG4RD-Cohort
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2012
• Last updated: April 7, 2017
• Start date: January 2012
• Est. completion date: January 2032

Study information

• Verified date: April 2017
• Source: Peking Union Medical College Hospital
• Contact: Hua Chen, MD
• Phone: 86-10-69158797
• Email: chen77hua[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2032
• Est. primary completion date: January 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• IgG4-related Disease

Locations

Country	Name	City	State
China	Deptment of Rheumatology, Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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