A Prospective Cohort Study of IgG4RD in China

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT01670695

Collaborator

(none)

1,000

Enrollment

Location

240

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cohort Study of Patients With IgG4-Related Disease

Actual Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2032

Anticipated Study Completion Date :

Jan 1, 2032

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males and females
Age 18-75 years old with informed consent
Patients with IgG4-RD:

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;
elevated serum IgG4 (>1.35 g/L)
histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deptment of Rheumatology, Peking Union Medical College Hospital	Beijing	Beijing	China	100032

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Principal Investigator: Wen Zhang, MD, Deptment of Rheumatology, Peking Union Medical College Hospital
Study Chair: Fengchun Zhang, Deptment of Rheumatology, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wen Zhang, Professor, Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT01670695

Other Study ID Numbers:

IgG4RD-Cohort

First Posted:

Aug 22, 2012

Last Update Posted:

Apr 11, 2017

Last Verified:

Apr 1, 2017

Keywords provided by Wen Zhang, Professor, Peking Union Medical College Hospital

IgG4-related disease

IgG4-RD

Additional relevant MeSH terms:

Immunoglobulin G4-Related Disease

Study Results

No Results Posted as of Apr 11, 2017