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Cohort Study of IgG4RD

This study is currently recruiting participants.
Verified August 2012 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Wen Zhang, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01670695
First received: August 16, 2012
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Phase
IgG4-related Disease
 Phase 0

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study of Patients With IgG4-Related Disease

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Clinical Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.


Biospecimen Retention:   Samples With DNA

blood samples (serum and plasma, with DNA)


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with newly diagnosed IgG4-related disease.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670695

Contacts
Contact: Hua Chen, MD 86-10-69158797 chen77hua@gmail.com

Locations
China, Beijing
Deptment of Rheumatology, Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100032
Contact: Wen Zhang, MD     86-10-69158795     zhangwen91@sina.com    
Contact: Hua Chen, MD     86-10-69158797     chen77hua@gmail.com    
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
  More Information

No publications provided

Responsible Party: Wen Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01670695     History of Changes
Other Study ID Numbers: IgG4RD-Cohort
Study First Received: August 16, 2012
Last Updated: August 20, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Peking Union Medical College Hospital:
IgG4-related disease
IgG4-RD

Additional relevant MeSH terms:
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013