A Prospective Cohort Study of IgG4RD in China
Cohort Study of Patients With IgG4-Related Disease
1 other identifier
observational
1,000
1 country
1
Brief Summary
This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 16, 2012
CompletedFirst Posted
Study publicly available on registry
August 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2032
April 11, 2017
April 1, 2017
20 years
August 16, 2012
April 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Response
Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.
6 months
Study Arms (1)
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.
Eligibility Criteria
Adult patients with newly diagnosed IgG4-related disease.
You may qualify if:
- 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);
You may not qualify if:
- Females planning to bear a child recently or with childbearing potential
- Concurrent severe and/or uncontrolled and/or unstable diseases
- Patient with malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deptment of Rheumatology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Related Publications (1)
Luo X, Peng Y, Zhang P, Li J, Liu Z, Lu H, Zhang X, Zeng X, Zhang F, Fei Y, Zhang W. Comparison of the Effects of Cyclophosphamide and Mycophenolate Mofetil Treatment Against Immunoglobulin G4-Related Disease: A Retrospective Cohort Study. Front Med (Lausanne). 2020 Jul 7;7:253. doi: 10.3389/fmed.2020.00253. eCollection 2020.
PMID: 32733900DERIVED
Biospecimen
blood samples (serum and plasma, with DNA)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 16, 2012
First Posted
August 22, 2012
Study Start
January 1, 2012
Primary Completion (Estimated)
January 1, 2032
Study Completion (Estimated)
January 1, 2032
Last Updated
April 11, 2017
Record last verified: 2017-04