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

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wen Zhang
• Treatments: Betamethasone dipropionate, betamethasone sodium phosphate drug combination

Criteria

Inclusion Criteria:

• Mikulicz disease, with/without nasosinusitis or lymph node swelling.

• Without internal organs affected,

• With slow disease progression.

Exclusion Criteria:

• Vital organs related:including autoimmune pancreatitis,retroperitoneal fibrosis, sclerosing cholangitis, lung related, kidney affected, IgG4 related castleman's disease and hypophysitis，

• Combined with other connective disease,

• With tumors,

• Pregnancy or to be pregnant,

• Active infection, including hepatitis B virus, hepatitis C virus, and tuberculosis.

• Leucocytopenia, impairment of liver and kidney function,

• Allergy of Iguratimod, or cannot tolerate Iguratimod.