Clinical trial NCT03368274: To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild Symptom
Official title: To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild Symptom
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: IgG4-related Disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The change of IgG4-RD responder index before treatment and after treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes of serum immunoglobulins subclass IgG4 levels
timeFrame: 24 weeks
measure: Patients serum cytokines
timeFrame: 24 weeks
measure: Peripheral blood lymphocytes sub-populations
timeFrame: 24 weeks
measure: Side effects
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wen Zhang
role: STUDY_CHAIR
References: