Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04919538
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2021-05-11
Brief Title:
Longitudinal Study for Relapsing Polychondritis
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Longitudinal Study for Relapsing Polychondritis
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Relapsing polychondritis RP is a rare systemic inflammatory disease characterized by recurrent inflammation of cartilage including ears nose tracheobronchial tree chest wall and joints Less commonly it can cause inflammation of eyes vasculature nervous system skin and inner ear The purpose of this study is to study the pathogenesis of RP
Detailed Description:
Relapsing polychondritis RP is a rare systemic inflammatory disease characterized by recurrent inflammation of cartilage including ears nose tracheobronchial tree chest wall and joints Less commonly it can cause inflammation of eyes vasculature nervous system skin and inner ear There is variability in organ-system involvement and the disease course is relapsing making the diagnosis challenging Delay in diagnosis can lead to end-organ damage and significant morbidity and mortality There are no biomarkers or blood tests that can assist with assignment of a diagnosis
Development of this longitudinal cohort and multicenter approach offers the potential to generate new insights and generate new questions regarding the immunology of the disease Attainment of a better understanding of the mechanisms and trajectory of inflammation may yield insights into potential new diagnostic and treatment strategies
Study visits will occur every 6 months or annually Blood and urine collection will occur at every visit A physical exam and medical and medication history will at every visit also participants will be asked to complete several questionnaires to assess disease activity health status and tobacco alcohol and drug use
Development of this longitudinal cohort and multicenter approach offers the potential to generate new insights and generate new questions regarding the immunology of the disease Attainment of a better understanding of the mechanisms and trajectory of inflammation may yield insights into potential new diagnostic and treatment strategies
Study visits will occur every 6 months or annually Blood and urine collection will occur at every visit A physical exam and medical and medication history will at every visit also participants will be asked to complete several questionnaires to assess disease activity health status and tobacco alcohol and drug use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None