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A Prospective Cohort Study of IgG4RD in China

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ClinicalTrials.gov Identifier: NCT01670695
Recruitment Status : Recruiting
First Posted : August 22, 2012
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Wen Zhang, gwcmc

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

Condition or disease
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 Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study of Patients With IgG4-Related Disease
Actual Study Start Date : January 2012
Estimated Primary Completion Date : January 2032
Estimated Study Completion Date : January 2032

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Clinical Response [ Time Frame: 6 months ]
    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)


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
gwcmc
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

Responsible Party: Wen Zhang, Professor, gwcmc
ClinicalTrials.gov Identifier: NCT01670695     History of Changes
Other Study ID Numbers: IgG4RD-Cohort
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Wen Zhang, gwcmc:
IgG4-related disease
IgG4-RD

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