Longitudinal Study for Relapsing Polychondritis

Recruiting

• Conditions: Relapsing Polychondritis; Vasculitis

• Registration Number: NCT04919538
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-02-26
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the pathogenesis of relapsing polychondritis using disease history.	Study completion; from baseline through month 36.	To study the manner of development of disease in patients affected with relapsing polychondritis.

Secondary Outcome Measures

Name	Time	Method
PROMIS Questionnaires	Baseline, month 6, month 12, month 18, month 24, month 30, month 36	Questions will ask about global health on the PROMIS short form.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States