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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients of IgG4-RD with mild symptoms are given one dose of diprospan and Iguratimod, 25mg, Bid.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe change of IgG4-RD responder index before treatment and after treatment
Evaluate patients baseline and follow-up IgG4-RD responder index(disease activity)
Time frame: 24 weeks
Changes of serum immunoglobulins subclass IgG4 levels
The IgG4 levels are tested routinely.
Time frame: 24 weeks
Patients serum cytokines
patients serum of cytokines detection by ELISA.
Time frame: 24 weeks
Peripheral blood lymphocytes sub-populations
Peripheral blood T,B sub-populations by flowcytometry
Time frame: 24 weeks
Side effects
Side effects, including laboratory tests will be recorded and tested.
Time frame: 24 weeks
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