Autoimmune Diseases, Autoinflammatory Diseases
Conditions
Keywords
Systemic Lupus Erythematosus, Juvenile Idiopathic Arthritis, Vasculitis, Juvenile Dermatomyositis, Sjogren's disease, Autoimmune, Autoinflammatory Disease, Scleroderma
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.
Interventions
None listed
Sponsors
Children's Hospital of Chongqing Medical University
Central South University
Beijing Children's Hospital
Shenzhen Children's Hospital
Children's Hospital of Nanjing Medical University
The University of Hong Kong
Zhejiang University
Third Hospital of Peking University
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Enrolled Patients | up to 10 years | Total number of patients with pediatric rheumatic and immunologic diseases enrolled in the registry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Childhood Health Assessment Questionnaire (CHAQ) | up to 10 years | Composite measure of functional disability, score from 0 (no disability) to 3 (severe disability) |
Countries
China
Contacts
Primary ContactSihao Gao
Outcome results
None listed