|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
27 February 2024 |
|
Main ID: |
NCT02418442 |
|
Date of registration:
|
13/04/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
|
|
Scientific title:
|
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry |
|
Date of first enrolment:
|
July 2015 |
|
Target sample size:
|
20000 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT02418442 |
|
Study type:
|
Observational [Patient Registry] |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Canada
|
Israel
|
Italy
|
Puerto Rico
|
United States
| | | |
|
Contacts
|
|
Name:
|
Mary Beth Son, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Boston Children's Hospital |
|
|
Name:
|
Timothy Beukelman, MD, MSCE |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Alabama at Birmingham |
|
|
Name:
|
Mara L Becker, MD, MSCE |
|
Address:
|
|
|
Telephone:
|
(919) 419-5032 |
|
Email:
|
mara.becker@duke.edu |
|
Affiliation:
|
|
|
|
Name:
|
Mara L Becker, MD, MSCE |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Duke Clinical Research Insitute |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19
years for all other rheumatic diseases (see appendix A).
2. Subject (and/or parent/legal guardian when required) is able to provide written
informed consent and willing to comply with study procedures.
3. Subject and/or parent/legal guardian is willing to be contacted in the future by study
staff.
Exclusion Criteria:
1. Greater than 21 years of age at the time of enrollment.
Age minimum:
N/A
Age maximum:
21 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Rheumatic Joint Disease
|
|
Primary Outcome(s)
|
|
Prospectively collect essential data elements from children, adolescents and young adults with pediatric rheumatic diseases
[Time Frame: Approximately 10 years]
|
|
Evaluate the safety of therapeutic agents in persons with pediatric onset rheumatic diseases
[Time Frame: Approximately 10 years]
|
|
Secondary Outcome(s)
|
|
Evaluate factors other than drug treatments that are associated with clinical outcomes in pediatric onset rheumatic diseases
[Time Frame: Approximately 10 years]
|
|
Document drug treatment patterns and clinical course of persons with pediatric onset rheumatic diseases over time.
[Time Frame: Approximately 10 years]
|
|
Evaluate clinical outcomes associated with the use of therapeutic agents in persons with pediatric onset rheumatic diseases
[Time Frame: Approximately 10 years]
|
|
Secondary ID(s)
|
|
Pro00054616
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|