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

NCT03368274 | Unknown Phase 4 DMC

• 1 other identifier: IgG4-RD Iguratimod
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

IgG4-related Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes of serum immunoglobulins subclass IgG4 levels

  24 weeks

• Patients serum cytokines

  24 weeks

• Peripheral blood lymphocytes sub-populations

  24 weeks

• Side effects

  24 weeks

Study Arms (1)

Signal arm study

EXPERIMENTAL

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

Interventions

T 614 DRUG

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

Also known as: diprospan

Signal arm study

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mikulicz disease, with/without nasosinusitis or lymph node swelling.
• Without internal organs affected,
• With slow disease progression.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wen Zhang: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

T 614; betamethasone dipropionate, betamethasone sodium phosphate drug combination

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Officials

• Wen Zhang

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Wen Zhang

CONTACT

86-10-69158795; zhangwen91@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

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

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: December 11, 2017
• Study Start: September 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)