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Clinical Trials in China / NCT01670695
Recruiting Observational

A Prospective Cohort Study of IgG4RD in China

NCT01670695 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Observational
Started
2012-01
Last updated
2017-04-11

Condition(s) studied

IgG4-related Disease

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Clinical Response — 6 months
    Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.

Trial sites (1)

FacilityCityRegionStatus
Deptment of Rheumatology, Peking Union Medical College Hospital Beijing Beijing Municipality Recruiting

More Peking Union Medical College Hospital trials in China

Spectral CT in Radiotherapy for Cervical Cancer Recruiting
Bowel Sound in Predicting the Severity of Acute Pancreatitis: Protocol of a Prospective, Multi-center Study Recruiting
TIME in Immunotherapy Combined With nCRT for Rectal Cancer Active, not recruiting
National Registry of IgG4-RD in China Recruiting
A Prospective Cohort Study of IRPF in China Recruiting

Other trials for the same condition

National Registry of IgG4-RD in China Recruiting
Safety and Efficacy of PRG-1801 for Refractory Lupus Nephritis and IgG4-Related Disease Recruiting
Safety and Efficacy of PRG-2311 for Refractory Lupus Nephritis and IgG4-Related Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01670695 on ClinicalTrials.gov ↗ ← All trials in China