A Prospective Cohort Study of IgG4RD in China

April 7, 2017 updated by: Wen Zhang, Peking Union Medical College Hospital

Cohort Study of Patients With IgG4-Related Disease

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Deptment of Rheumatology, Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with newly diagnosed IgG4-related disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Anticipated)

January 1, 2032

Study Completion (Anticipated)

January 1, 2032

Study Registration Dates

First Submitted

August 16, 2012

First Submitted That Met QC Criteria

August 20, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IgG4RD-Cohort

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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