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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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IgG4-related Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

To compare IgG4-RD responder index, serum parameters and blood lymphocytes subpopulations at baseline and after treatment of 12 weeks and 24 weeks

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Signal arm study

Patients with mild symptom IgG4-RD are enrolled and inject one dosage of diprospan ,then take Iguratimod (T614), 25mg, Bid orally for three months. Firstly, we evaluate IgG4-RD responder index of patients at baseline and follow-up time.We collect the laboratory parameters and blood for lymphocytes subpopulations by flowcytometry.

Group Type EXPERIMENTAL

T 614

Intervention Type DRUG

Patients of IgG4-RD with mild symptoms are given one dose of diprospan and Iguratimod, 25mg, Bid.

Interventions

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T 614

Patients of IgG4-RD with mild symptoms are given one dose of diprospan and Iguratimod, 25mg, Bid.

Intervention Type DRUG

Other Intervention Names

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diprospan

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No