A Prospective Cohort Study of IgG4RD in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: IgG4-related Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cohort Study of Patients With IgG4-Related Disease
Overview
This is an cohort study to investigate the disease course and treatment response of patients with 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.
Primary outcome measures
- Clinical Response [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Deptment of Rheumatology, Peking Union Medical College Hospital — Beijing
Publications
- 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 32733900
Identifiers
NCT: NCT01670695 · IgG4RD-Cohort