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

IgG4-related Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03368274
• Other study ID #: IgG4-RD Iguratimod
• Status: Recruiting
• Phase: Phase 4
• First received: September 20, 2017
• Last updated: April 10, 2018
• Start date: September 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: April 2018
• Source: Peking Union Medical College Hospital
• Contact: Wen Zhang
• Phone: 86-10-69158795
• Email: zhangwen91[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• IgG4-related Disease

Intervention

Drug:
• T 614
Patients of IgG4-RD with mild symptoms are given one dose of diprospan and Iguratimod, 25mg, Bid.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Wen Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of IgG4-RD responder index before treatment and after treatment	Evaluate patients baseline and follow-up IgG4-RD responder index(disease activity)	24 weeks
Secondary	Changes of serum immunoglobulins subclass IgG4 levels	The IgG4 levels are tested routinely.	24 weeks
Secondary	Patients serum cytokines	patients serum of cytokines detection by ELISA.	24 weeks
Secondary	Peripheral blood lymphocytes sub-populations	Peripheral blood T,B sub-populations by flowcytometry	24 weeks
Secondary	Side effects	Side effects, including laboratory tests will be recorded and tested.	24 weeks