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NCT Number: NCT06417502

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

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

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Key information

Conditions

Autoimmune Diseases Arthritis Arthritis, Juvenile Arthritis, Rheumatoid Autoinflammatory Diseases Cardiovascular Diseases Connective Tissue Diseases Dermatomyositis Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Lupus Erythematosus, Systemic Mouth Diseases Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Polymyositis Rheumatic Diseases Salivary Gland Diseases Scleroderma, Diffuse Scleroderma, Systemic Sjogren's Syndrome Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Vascular Diseases Vasculitis Xerostomia

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Children's Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Physician Global Assessment

    Time frame: up to 10 years

    Visual Analog Score measurement of disease activity by physicians. The minimum value is 0 and the maximum is 10.

  2. Patient or Parent Global Assessment

    Time frame: 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.

  3. Proportion of Participants with Clinically Inactive Disease

    Time frame: 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.

  4. Childhood Health Assessment Questionnaire (CHAQ)

    Time frame: up to 10 years

    Composite measure of functional disability, score from 0 (no disability) to 3 (severe disability)

Study contacts

Contact information is provided by the study sponsor or research team.

Sihao Gao

CONTACT

[email protected]

(+86) 010-6915-5727

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Beijing Children's Hospital
  • Central South University
  • Children's Hospital of Chongqing Medical University
  • Children's Hospital of Nanjing Medical University
  • Peking University Third Hospital
  • Shenzhen Children's Hospital
  • The University of Hong Kong
  • Zhejiang University

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2031
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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