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

Phase 4

• Conditions: IgG4-related Disease
• Interventions: Drug: T 614

• Registration Number: NCT03368274
• Lead Sponsor: Wen Zhang

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Signal arm study	T 614	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Side effects	24 weeks	Side effects, including laboratory tests will be recorded and tested.
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China