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

May 11, 2024 updated by: Hongmei Song, Peking Union Medical College Hospital
An observational, multi-center, longitudinal registry study for Chinese pediatric patients with rheumatic and immunologic diseases.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hongmei Song, MD
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Children's Hospital, Capital Medical University
        • Contact:
          • Huawei Mao, MD, PhD
      • Beijing, Beijing, China
        • Recruiting
        • Third Hospital of Peking University
        • Contact:
          • Zhiqiang Yan, PhD
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Chidren's Hospital of Chongqing Medical University
        • Contact:
          • Xuemei Tang, MD
    • Guangdong
      • Shenzhen, Guangdong, China
        • Recruiting
        • Shenzhen Children's Hospital
        • Contact:
          • Jun Yang, MD
      • Shenzhen, Guangdong, China
        • Recruiting
        • The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI)
        • Contact:
          • Wanling Yang, PhD
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • Xiaochuan Wu, MD
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Children's Hospital of Nanjing Medical University
        • Contact:
          • Haiguo Yu, MD
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Children's Hospital of Zhejiang University School of Medicine
        • Contact:
          • Meiping Lu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chinese children with pediatric rheumatic and immunologic diseases enrolled from CAPRID centers.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Enrolled Patients
Time Frame: up to 10 years
Total number of patients with pediatric rheumatic and immunologic diseases enrolled in the registry
up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 10 years
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.
up to 10 years
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.
up to 10 years
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)
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Central South University
Zhejiang University
Beijing Children's Hospital
Shenzhen Children's Hospital
Children's Hospital of Chongqing Medical University
Children's Hospital of Nanjing Medical University
Third Hospital of Peking University
The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI)

Investigators

  • Principal Investigator: Hongmei Song, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2022

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 11, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-3362D
  • 2021YFC2702000 (Other Grant/Funding Number: National Key R&D Program of China)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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