NCT06417502

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Apr 2022Dec 2031

Study Start

First participant enrolled

April 29, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Expected
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2.6 years

First QC Date

May 7, 2024

Last Update Submit

May 11, 2024

Conditions

Keywords

Systemic Lupus ErythematosusJuvenile Idiopathic ArthritisVasculitisJuvenile DermatomyositisSjogren's diseaseAutoimmuneAutoinflammatory DiseaseScleroderma

Outcome Measures

Primary Outcomes (1)

  • Number of Enrolled Patients

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

    up to 10 years

Secondary Outcomes (4)

  • Physician Global Assessment

    up to 10 years

  • Patient or Parent Global Assessment

    up to 10 years

  • Proportion of Participants with Clinically Inactive Disease

    up to 10 years

  • Childhood Health Assessment Questionnaire (CHAQ)

    up to 10 years

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Third Hospital of Peking University

Beijing, Beijing Municipality, China

RECRUITING

Chidren's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Shenzhen Children's Hospital

Shenzhen, Guangdong, China

RECRUITING

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

Shenzhen, Guangdong, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Related Links

MeSH Terms

Conditions

Autoimmune DiseasesLupus Erythematosus, SystemicArthritis, JuvenileVasculitisDermatomyositisSjogren's SyndromeScleroderma, Diffuse

Condition Hierarchy (Ancestors)

Immune System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesVascular DiseasesCardiovascular DiseasesPolymyositisMyositisMuscular DiseasesNeuromuscular DiseasesNervous System DiseasesSkin DiseasesArthritis, RheumatoidXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesScleroderma, Systemic

Study Officials

  • Hongmei Song, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 16, 2024

Study Start

April 29, 2022

Primary Completion

November 30, 2024

Study Completion (Estimated)

December 31, 2031

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations