Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry
- Conditions
- Autoimmune DiseasesAutoinflammatory Diseases
- Registration Number
- NCT06417502
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20000
- 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
- Disagreement of involving in this study by the patient or his/her family.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Enrolled Patients up to 10 years Total number of patients with pediatric rheumatic and immunologic diseases enrolled in the registry
- Secondary Outcome Measures
Name Time Method Physician Global Assessment up to 10 years Visual Analog Score measurement of disease activity by physicians. The minimum value is 0 and the maximum is 10.
Proportion of Participants with Clinically Inactive Disease up to 10 years 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.Patient or Parent Global Assessment up to 10 years 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.
Childhood Health Assessment Questionnaire (CHAQ) up to 10 years Composite measure of functional disability, score from 0 (no disability) to 3 (severe disability)
Trial Locations
- Locations (9)
Shenzhen Children's Hospital
🇨🇳Shenzhen, Guangdong, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Third Hospital of Peking University
🇨🇳Beijing, Beijing, China
Beijing Children's Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Chidren's Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI)
🇨🇳Shenzhen, Guangdong, China
Children's Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Children's Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China