To Evaluate the Clinical Efficacy of Iguratimod in the Tr... | NCT03368274

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

NCT03368274

Sponsor

Wen Zhang

Status

Unknown status

Last Update Posted

Apr 11, 2018Actual

Enrollment

30Estimated

Phase

Phase 4

Conditions

IgG4-related Disease

Interventions

T 614

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Jun 1, 2018Estimated

Completion Date

Jun 1, 2018Estimated

First Submitted Date

Sep 20, 2017

First Submission Date that Met QC Criteria

Dec 5, 2017

First Posted Date

Dec 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2018

Last Update Posted Date

Apr 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wen Zhang, professor, Peking Union Medical College HospitalSponsor-Investigator

Lead Sponsor

Wen ZhangOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
T 614	Drug	Patients of IgG4-RD with mild symptoms are given one dose of diprospan and Iguratimod, 25mg, Bid.	Signal arm study

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wen Zhang	Contact	86-10-69158795		zhangwen91@sina.com

Overall Officials

Name	Affiliation	Role
Wen Zhang	Peking Union Medical College Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality	100032	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077733	Immunoglobulin G4-Related Disease

Ancestor Terms

ID	Term
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C077313	T 614
C032812	betamethasone dipropionate, betamethasone sodium phosphate drug combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided