Clinical trial Recruiting at 1 site Observational Ages 18 to 75

Observational study of IgG4-related disease in China

Official title: Cohort Study of Patients With IgG4-Related Disease

Run by Peking Union Medical College Hospital · NCT01670695 · Data updated 2026-11-12

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 typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment1000 (estimated)
SponsorPeking Union Medical College Hospital
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJanuary 2012
Main results expectedJanuary 2032
Study endsJanuary 2032
Registry record updatedApril 11, 2017
Trial IDNCT01670695 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include males and females aged 18-75 with a confirmed diagnosis of IgG4-related disease and elevated serum IgG4 levels.

Probably not a fit

Patients with concurrent severe diseases, malignancies, or those planning to become pregnant may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While IgG4-related disease is a relatively new clinical entity, similar observational studies have shown promise in understanding its pathology and treatment responses.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.