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

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.

Study Overview

• Status: Unknown
• Conditions: IgG4-related Disease
• Intervention / Treatment: Drug: T 614

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wen Zhang; Phone Number: 86-10-69158795; Email: zhangwen91@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Panpan Zhang; Phone Number: +8618800159311; Email: panpanzhang2016@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: T 614; Patients of IgG4-RD with mild symptoms are given one dose of diprospan and Iguratimod, 25mg, Bid.; Other Names: diprospan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of serum immunoglobulins subclass IgG4 levels	The IgG4 levels are tested routinely.	24 weeks
Patients serum cytokines	patients serum of cytokines detection by ELISA.	24 weeks
Peripheral blood lymphocytes sub-populations	Peripheral blood T,B sub-populations by flowcytometry	24 weeks
Side effects	Side effects, including laboratory tests will be recorded and tested.	24 weeks

Collaborators and Investigators

• Sponsor: Wen Zhang
• Investigators: Study Chair: Wen Zhang, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Immunoglobulin G4-Related Disease; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Betamethasone dipropionate, betamethasone sodium phosphate drug combination
• Other Study ID Numbers: IgG4-RD Iguratimod

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No