Longitudinal Study for Relapsing Polychondritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Longitudinal Study for Relapsing Polychondritis

Conditions
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Relapsing Polychondritis, Vasculitis

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relapsing Polychondritis Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RP