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Autoimmune DiseasesNCT06417502

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

An observational study of Autoimmune Diseases and Autoinflammatory Diseases, run by Peking Union Medical College Hospital at 9 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages Up to 18 years
How many people
20,000 participants
Where
9 sitesChina
Study dates
29 Apr 2022to 31 Dec 2031
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

  • Disagreement of involving in this study by the patient or his/her family.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sihao Gao contact

(+86) 010-6915-5727

sihao.gao@gmail.com

9 sites in 1 country

China9 sites, 9 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Hongmei Song, MD, PhD, +86-10-69156271, songhm1021@126.com

    Sihao Gao, +86-10-69156271, sihao.gao@gmail.com

    Recruiting

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Huawei Mao, MD, PhD

    Recruiting

  • Third Hospital of Peking University

    Beijing, Beijing Municipality

    Zhiqiang Yan, PhD

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Xiaochuan Wu, MD

    Recruiting

  • Chidren's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Xuemei Tang, MD

    Recruiting

  • Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Meiping Lu, MD

    Recruiting

  • Children's Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Haiguo Yu, MD

    Recruiting

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong

    Jun Yang, MD

    Recruiting

  • The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI)

    Shenzhen, Guangdong

    Wanling Yang, PhD

    Recruiting

Other trials in China

About this study

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

Read the 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.

Keywords
Systemic Lupus Erythematosus, Juvenile Idiopathic Arthritis, Vasculitis, Juvenile Dermatomyositis, Sjogren's disease, Autoimmune, Autoinflammatory Disease, Scleroderma
Medical subject headings
Autoimmune Diseases, Lupus Erythematosus, Systemic, Arthritis, Juvenile, Vasculitis, Dermatomyositis, Sjogren's Syndrome, Scleroderma, Diffuse

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Enrolled Patients

    Total number of patients with pediatric rheumatic and immunologic diseases enrolled in the registry

    Measured: up to 10 years

Secondary outcomes (4)

  1. Physician Global Assessment

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

    Measured: up to 10 years

  2. Patient or Parent Global Assessment

    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.

    Measured: up to 10 years

  3. Proportion of Participants with Clinically Inactive Disease

    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.

    Measured: up to 10 years

  4. Childhood Health Assessment Questionnaire (CHAQ)

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

    Measured: up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start29 Apr 2022
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20,000 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06417502
Sponsor's protocol ID
JS-3362D
Other IDs
2021YFC2702000
Status last verified
May 2024
First submitted
7 May 2024
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Autoimmune Diseases and Autoinflammatory Diseases, run by Peking Union Medical College Hospital at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sihao Gao ((+86) 010-6915-5727, sihao.gao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Enrolled Patients (time frame: up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06417502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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