Longitudinal Study for Relapsing Polychondritis

Vasculitis Clinical Trial

Official title:

Longitudinal Study for Relapsing Polychondritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04919538
• Other study ID #: VCRC5508
• Status: Recruiting
• Start date: February 26, 2021
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: Carol McAlear
• Phone: 7813214567
• Email: cmcalear[@]upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 1. Any subject considered to have a diagnosis of relapsing polychondritis according to the investigator.

Exclusion Criteria:

• 1. Inability to provide consent, or in the case of minors, assent.

Related Conditions & MeSH terms

• Relapsing Polychondritis
• Vasculitis

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the pathogenesis of relapsing polychondritis using disease history.	To study the manner of development of disease in patients affected with relapsing polychondritis.	Study completion; from baseline through month 36.
Secondary	PROMIS Questionnaires	Questions will ask about fatigue on the PROMIS short form.	Baseline, month 6, month 12, month 18, month 24, month 30, month 36
Secondary	PROMIS Questionnaires	Questions will ask about pain interference on the PROMIS short form.	Baseline, month 6, month 12, month 18, month 24, month 30, month 36
Secondary	PROMIS Questionnaires	Questions will ask about physical function on the PROMIS short form.	Baseline, month 6, month 12, month 18, month 24, month 30, month 36
Secondary	PROMIS Questionnaires	Questions will ask about global health on the PROMIS short form.	Baseline, month 6, month 12, month 18, month 24, month 30, month 36

External Links

•   Rare Diseases Clinical Research Network (RDCR)
•   Relapsing Polychondritis Foundation
•   Vasculitis Clinical Research Consortium