National Registry of IgG4-RD in China

Recruiting

• Conditions: IgG4-Related Disease

• Registration Number: NCT03023371
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-14
• Study First Posted: 2017-01-18
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Organ involvements of Chinese IgG4-RD patients	5 years	To calculate the percentage of organ involvements in at least 900 patients.

Secondary Outcome Measures

Name	Time	Method
Ten year survival rate of patients with IgG4 related disease in China.	10 years
Relapse rate of IgG4-RD patients in China	5 years
The imaging features of involved organs.	3 years
The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease.	3 years
Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China	5 years
The correlation between baseline disease activities and relapse rate.	5 years
The incidence rate of tumor in IgG4 related disease patients in China.	5 years

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China