Cohort Study of IgG4RD
This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cohort Study of Patients With IgG4-Related Disease|
- Clinical Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.
Biospecimen Retention: Samples With DNA
blood samples (serum and plasma, with DNA)
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670695
|Contact: Hua Chen, MDemail@example.com|
|Deptment of Rheumatology, Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100032|
|Contact: Wen Zhang, MD 86-10-69158795 firstname.lastname@example.org|
|Contact: Hua Chen, MD 86-10-69158797 email@example.com|
|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|