Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry

Autoimmune Diseases Clinical Trial

Official title:

Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417502
• Other study ID #: JS-3362D
• Secondary ID: 2021YFC2702000
• Status: Recruiting
• Start date: April 29, 2022
• Est. completion date: December 31, 2031

Study information

• Verified date: May 2024
• Source: Peking Union Medical College Hospital
• Contact: Sihao Gao
• Phone: (+86) 010-6915-5727
• Email: sihao.gao[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

An observational, multi-center, longitudinal registry study for Chinese pediatric patients with rheumatic and immunologic diseases.

Description:

Pediatric rheumatic and immunologic diseases severely impact the health of children and adolescents. Chinese Alliance of Pediatric Rheumatic & Immunologic Diseases (CAPRID) was founded in 2022 to form a national collaboration for high-quality data-driven multi-center pediatric rheumatology and immunology research in China. The CAPRID Registry is an observational, multi-center, longitudinal registry for Chinese pediatric patients with rheumatic and immunologic diseases to explore the clinical phenotypes, diagnoses, complications, real-world drug safety, therapeutic efficacy, adverse events, critical illness and outcomes of Chinese pediatric patients with rheumatic and immunologic diseases.

Hospital-based databases are established and standardized with Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) for routine data collection. A web-based registry website is established with standardized electronic case report forms to register patients from CAPRID centers. A mobile application is created to allow long-term follow up and patient-reported outcome collection. The data captured in this registry reflects a "real world" situation with no intervention done outside the routine clinical practice. Treatment plans are determined by the investigator.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2031
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Age <= 18 years old

• Diagnosed with rheumatic and immunologic diseases (including diffuse connective tissue diseases, arthritis, vasculitis, inborn errors of immunity)

• Diagnosed and Treated in China

Exclusion Criteria:

• Disagreement of involving in this study by the patient or his/her family.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autoinflammatory Diseases
• Immune System Diseases

Locations

Country	Name	City	State
China	Beijing Children's Hospital, Capital Medical University	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Third Hospital of Peking University	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Chidren's Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Children's Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Shenzhen Children's Hospital	Shenzhen	Guangdong
China	The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI)	Shenzhen	Guangdong

Sponsors (9)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Children's Hospital, Central South University, Children's Hospital of Chongqing Medical University, Children's Hospital of Nanjing Medical University, Shenzhen Children's Hospital, The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI), Third Hospital of Peking University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Enrolled Patients	Total number of patients with pediatric rheumatic and immunologic diseases enrolled in the registry	up to 10 years
Secondary	Physician Global Assessment	Visual Analog Score measurement of disease activity by physicians. The minimum value is 0 and the maximum is 10.	up to 10 years
Secondary	Patient or Parent Global Assessment	Visual Analog Score measurement of disease activity by patient's parent or patient him or her self (above 8 years old). The minimum value is 0 and the maximum is 10.	up to 10 years
Secondary	Proportion of Participants with Clinically Inactive Disease	Defined by normal disease activity indexes (if available) and normal inflammatory markers (erythrocyte sedimentation rate and C-reactive protein).; Disease activity indexes include Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) for systemic lupus erythematosus; Juvenile Arthritis Disease Activity Score (JADAS)-27 for juvenile idiopathic arthritis, Pediatric Vasculitis Activity Score (PVAS) for vasculitis; Manual Muscle Testing(MMT)8, Childhood Myositis Assessment Scale (CMAS) for juvenile dermatomyositis, Sjögren's syndrome disease activity index (ESSDAI) for Sjögren's syndrome, Modified Rodnan Skin Score for scleroderma.	up to 10 years
Secondary	Childhood Health Assessment Questionnaire (CHAQ)	Composite measure of functional disability, score from 0 (no disability) to 3 (severe disability)	up to 10 years

External Links

•   The Official Website for Chinese Alliance of Pediatric Rheumatic & Immunologic Diseases (CAPRID)