Observational study of IgG4-related disease in China
Cohort Study of Patients With IgG4-Related Disease
This study looks at how IgG4-related disease affects patients in China and how well they respond to standard treatment over at least six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT01670695 on ClinicalTrials.gov |
What this trial studies
This cohort study aims to investigate the disease course and treatment response of patients diagnosed with IgG4-related disease (IgG4-RD). It will involve assessing clinical presentations, laboratory findings, and imaging studies of participants. All enrolled patients will receive standard care and will be followed for a minimum of six months to monitor their progress and response to treatment.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18-75 with a confirmed diagnosis of IgG4-related disease and elevated serum IgG4 levels.
Not a fit: Patients with concurrent severe diseases, malignancies, or those planning to become pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of IgG4-RD and improve treatment strategies for affected patients.
How similar studies have performed: While IgG4-related disease is a relatively new clinical entity, similar observational studies have shown promise in understanding its pathology and treatment responses.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Deptment of Rheumatology, Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Wen Zhang, MD — Deptment of Rheumatology, Peking Union Medical College Hospital
- Study coordinator: Hua Chen, MD
- Email: chen77hua@gmail.com
- Phone: 86-10-69158797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.