Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20,000
- Locations
- 9
- Primary Endpoint
- Number of Enrolled Patients
Study Overview
Brief Summary
An observational, multi-center, longitudinal registry study for Chinese pediatric patients with rheumatic and immunologic diseases.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Number of Enrolled Patients
Time Frame: up to 10 years
Total number of patients with pediatric rheumatic and immunologic diseases enrolled in the registry
Secondary Outcomes
- Physician Global Assessment(up to 10 years)
- Proportion of Participants with Clinically Inactive Disease(up to 10 years)
- Childhood Health Assessment Questionnaire (CHAQ)(up to 10 years)
- Patient or Parent Global Assessment(up to 10 years)
Investigators
Hongmei Song
MD
Peking Union Medical College Hospital