National Registry of IgG4-RD in China

IgG4-Related Disease Clinical Trial

Official title:

National Registry of IgG4-RD in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03023371
• Other study ID #: IgG4-RD Group in China
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2017
• Last updated: January 23, 2017
• Start date: December 2016
• Est. completion date: December 2026

Study information

• Verified date: January 2017
• Source: Peking Union Medical College Hospital
• Contact: Yunyun Fei
• Phone: +8613681125226
• Email: feiyunyun2013[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to establish a nation-wide cohort study of IgG4-related disease (IgG4-RD) in China.

Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) would be enrolled from multi-centers around China. A online database system has been established.

Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese IgG4-RD patients; the secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

Description:

This is a multicenter registry study of IgG4-RD patients. Newly diagnosed IgG4-RD patients will be recruited from allover the China. Inclusion criteria: patients with definite, probable, or possible IgG4-RD according to the 2011 comprehensive diagnostic criteria for IgG4-RD will be recruited. Exclusion criteria: patients with malignancy or other autoimmune diseases are excluded.

The data will be uploaded through the platform of Chinese Rheumatology Information Platform. Demographic data, initial symptoms, disease duration, history of allergy, and physical examination, organ involvements, laboratory findings, radiological and pathological results, as well as treatment, side effects will be recorded.

This study was approved by the Medical Ethics Committee of PUMCH (Beijing, China). All patients will signe informed consent.

Statistical Analysis: All parameters are described in the standard summary statistics, including mean, standard deviation, minimum, and maximum. All statistical analyses will be performed by SPSS.

Endpoints: The primary endpoint is to investigate the organ involvements of Chinese IgG4-RD patients. The secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Conforming to the diagnostic criteria of IgG4-RD (2011);

Exclusion Criteria:

• Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.

Related Conditions & MeSH terms

• IgG4-Related Disease

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Organ involvements of Chinese IgG4-RD patients	To calculate the percentage of organ involvements in at least 900 patients.	5 years
Secondary	Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China		5 years
Secondary	Relapse rate of IgG4-RD patients in China		5 years
Secondary	The correlation between baseline disease activities and relapse rate.		5 years
Secondary	The incidence rate of tumor in IgG4 related disease patients in China.		5 years
Secondary	Ten year survival rate of patients with IgG4 related disease in China.		10 years
Secondary	The imaging features of involved organs.		3 years
Secondary	The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease.		3 years