Clinical trial NCT06417502: Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry
Official title: Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Diseases
Autoinflammatory Diseases
Keywords: Systemic Lupus Erythematosus
Juvenile Idiopathic Arthritis
Vasculitis
Juvenile Dermatomyositis
Sjogren's disease
Autoimmune
Autoinflammatory Disease
Scleroderma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
name: Central South University
name: Beijing Children's Hospital
name: Shenzhen Children's Hospital
name: Children's Hospital of Nanjing Medical University
name: The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI)
name: Zhejiang University
name: Third Hospital of Peking University
First posted: 2024-05-16
Enrollment: 20000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese children with pediatric rheumatic and immunologic diseases enrolled from CAPRID centers.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Enrolled Patients
timeFrame: up to 10 years
Secondary outcomes:
measure: Physician Global Assessment
timeFrame: up to 10 years
measure: Patient or Parent Global Assessment
timeFrame: up to 10 years
measure: Proportion of Participants with Clinically Inactive Disease
timeFrame: up to 10 years
measure: Childhood Health Assessment Questionnaire (CHAQ)
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Third Hospital of Peking University
state: Beijing
city: Chongqing
country: China
facility: Chidren's Hospital of Chongqing Medical University
state: Chongqing
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI)
state: Guangdong
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Children's Hospital of Nanjing Medical University
state: Jiangsu
city: Hangzhou
country: China
facility: Children's Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Hongmei Song, MD
role: PRINCIPAL_INVESTIGATOR
References: