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To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild Symptom

IgG4-related Disease Clinical Trial

Official title:
To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild Symptom

Clinical Trial Summary

30 untreated IgG4 related disease (IgG4-RD) patients with mild symptom are enrolled in this study, and will be treated with one dose of diprospan,then take Iguratimod 25mg, Bid orally. Patient's peripheral blood will be collected at baseline, 12 weeks and 24 weeks of follow up. The clinical efficacy will be evaluated by the IgG4-RD responder index, serum immunoglobulin, IgG4 and IgE, cytokines, and peripheral blood T cell and B cell sub-populations will be measured at baseline and follow up.

Clinical Trial Description

Glucocorticoid is the recognized first-line medication for IgG4-RD, but it has many side effects. In order to avoid long time glucocorticoids intake, patients with mild disease will be treated with Iguratimod combined with one dose of diprospan. 30 untreated IgG4-RD patients with mild symptom will be enrolled in this study, and be treated with one dose of diprospan,then take Iguratimod 25mg, Bid orally. 5 ml of patients' peripheral blood will be collected at baseline, 12 weeks and 24 weeks of follow up. At baseline and each follow-up, the clinical efficacy of treatment will be evaluated by IgG4-RD responder index, serum immunoglobulin, IgG4, immunoglobulin E (IgE), serum cytokines, such as interleukin 1, 6, and tumor necrosis factor, will be measured by ELISA, peripheral blood T cell sub-populations, B cell sub-populations and plasma cells will be measured by flow-cytometry. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03368274
Study type Interventional
Source Peking Union Medical College Hospital
Contact Wen Zhang
Phone 86-10-69158795
Email zhangwen91@sina.com
Status Recruiting
Phase Phase 4
Start date September 1, 2017
Completion date June 1, 2018
View Details
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