## Protocol Section
### Identification Module
**NCT ID:** NCT06417502

**Brief Title:** 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

#### Organization Study ID Info
**ID:** JS-3362D
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
#### Secondary ID Infos
**Domain:** National Key R&D Program of China
**ID:** 2021YFC2702000
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2031-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-04-29

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Children's Hospital of Chongqing Medical University

**Class:** OTHER

**Name:** Central South University

**Class:** OTHER

**Name:** Beijing Children's Hospital

**Class:** OTHER_GOV

**Name:** Shenzhen Children's Hospital

**Class:** OTHER

**Name:** Children's Hospital of Nanjing Medical University

**Class:** UNKNOWN

**Name:** The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI)

**Class:** OTHER

**Name:** Zhejiang University

**Class:** UNKNOWN

**Name:** Third Hospital of Peking University

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking Union Medical College Hospital

#### Responsible Party

**Investigator Affiliation:** Peking Union Medical College Hospital

**Investigator Full Name:** Hongmei Song

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Autoimmune Diseases

- Autoinflammatory Diseases

**Keywords:**

- Systemic Lupus Erythematosus

- Juvenile Idiopathic Arthritis

- Vasculitis

- Juvenile Dermatomyositis

- Sjogren's disease

- Autoimmune

- Autoinflammatory Disease

- Scleroderma

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 20000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Years

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Number of Enrolled Patients

**Time Frame:** up to 10 years

#### Secondary Outcomes

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

**Measure:** Physician Global Assessment

**Time Frame:** up to 10 years

**Description:** 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.

**Measure:** Patient or Parent Global Assessment

**Time Frame:** up to 10 years

**Description:** 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.

**Measure:** Proportion of Participants with Clinically Inactive Disease

**Time Frame:** up to 10 years

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

**Measure:** Childhood Health Assessment Questionnaire (CHAQ)

**Time Frame:** up to 10 years

### Eligibility Module

**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.

**Maximum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sihao.gao@gmail.com

**Name:** Sihao Gao

**Phone:** (+86) 010-6915-5727

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** songhm1021@126.com

- **Name:** Hongmei Song, MD, PhD

- **Phone:** +86-10-69156271

- **Role:** CONTACT

***Contact 2:***

- **Email:** sihao.gao@gmail.com

- **Name:** Sihao Gao

- **Phone:** +86-10-69156271

- **Role:** CONTACT

***Contact 3:***

- **Name:** Hongmei Song, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Peking Union Medical College Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100730

**Location 2:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Name:** Huawei Mao, MD, PhD

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Children's Hospital, Capital Medical University

**State:** Beijing

**Status:** RECRUITING

**Location 3:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Name:** Zhiqiang Yan, PhD

- **Role:** CONTACT

**Country:** China

**Facility:** Third Hospital of Peking University

**State:** Beijing

**Status:** RECRUITING

**Location 4:**

**City:** Chongqing

**Contacts:**

***Contact 1:***

- **Name:** Xuemei Tang, MD

- **Role:** CONTACT

**Country:** China

**Facility:** Chidren's Hospital of Chongqing Medical University

**State:** Chongqing

**Status:** RECRUITING

**Location 5:**

**City:** Shenzhen

**Contacts:**

***Contact 1:***

- **Name:** Jun Yang, MD

- **Role:** CONTACT

**Country:** China

**Facility:** Shenzhen Children's Hospital

**State:** Guangdong

**Status:** RECRUITING

**Location 6:**

**City:** Shenzhen

**Contacts:**

***Contact 1:***

- **Name:** Wanling Yang, PhD

- **Role:** CONTACT

**Country:** China

**Facility:** The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI)

**State:** Guangdong

**Status:** RECRUITING

**Location 7:**

**City:** Changsha

**Contacts:**

***Contact 1:***

- **Name:** Xiaochuan Wu, MD

- **Role:** CONTACT

**Country:** China

**Facility:** The Second Xiangya Hospital of Central South University

**State:** Hunan

**Status:** RECRUITING

**Location 8:**

**City:** Nanjing

**Contacts:**

***Contact 1:***

- **Name:** Haiguo Yu, MD

- **Role:** CONTACT

**Country:** China

**Facility:** Children's Hospital of Nanjing Medical University

**State:** Jiangsu

**Status:** RECRUITING

**Location 9:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Name:** Meiping Lu, MD

- **Role:** CONTACT

**Country:** China

**Facility:** Children's Hospital of Zhejiang University School of Medicine

**State:** Zhejiang

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Peking Union Medical College Hospital

**Name:** Hongmei Song, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** The Official Website for Chinese Alliance of Pediatric Rheumatic \& Immunologic Diseases (CAPRID)

**URL:** https://caprid.pumch.cn

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: HIGH

- As Found: Autoimmune Diseases

- ID: M15412

- Name: Scleroderma, Systemic

- Relevance: LOW

- As Found: Unknown

- ID: M25560

- Name: Scleroderma, Diffuse

- Relevance: LOW

- As Found: Unknown

- ID: M7077

- Name: Dermatomyositis

- Relevance: LOW

- As Found: Unknown

- ID: M4479

- Name: Arthritis, Juvenile

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11177

- Name: Lupus Erythematosus, Systemic

- Relevance: LOW

- As Found: Unknown

- ID: M17405

- Name: Vasculitis

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: HIGH

- As Found: Immunologic Diseases

- ID: T5565

- Name: Systemic Scleroderma

- Relevance: LOW

- As Found: Unknown

- ID: T1814

- Name: Dermatomyositis

- Relevance: LOW

- As Found: Unknown

- ID: T3171

- Name: Juvenile Dermatomyositis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Misc Info Module

- Version Holder: 2024-05-31
