IgG4-related Disease
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGT 614
Patients of IgG4-RD with mild symptoms are given one dose of diprospan and Iguratimod, 25mg, Bid.
Sponsors
Wen Zhang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
To compare IgG4-RD responder index, serum parameters and blood lymphocytes subpopulations at baseline and after treatment of 12 weeks and 24 weeks
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of IgG4-RD responder index before treatment and after treatment | 24 weeks | Evaluate patients baseline and follow-up IgG4-RD responder index(disease activity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of serum immunoglobulins subclass IgG4 levels | 24 weeks | The IgG4 levels are tested routinely. |
| Patients serum cytokines | 24 weeks | patients serum of cytokines detection by ELISA. |
| Peripheral blood lymphocytes sub-populations | 24 weeks | Peripheral blood T,B sub-populations by flowcytometry |
| Side effects | 24 weeks | Side effects, including laboratory tests will be recorded and tested. |
Countries
China
Contacts
Primary ContactWen Zhang
Outcome results
None listed