Clinical trial NCT04919538: Longitudinal Study for Relapsing Polychondritis
Official title: Longitudinal Study for Relapsing Polychondritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Relapsing Polychondritis
Vasculitis
Keywords: RP
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with relapsing polychondritis (RP). Enrollment will be sequential and participants will have disease in various stages and of different duration.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the pathogenesis of relapsing polychondritis using disease history.
timeFrame: Study completion; from baseline through month 36.
Secondary outcomes:
measure: PROMIS Questionnaires
timeFrame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: PROMIS Questionnaires
timeFrame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: PROMIS Questionnaires
timeFrame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: PROMIS Questionnaires
timeFrame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Peter Merkel, MD, MPH
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Shubhasree Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
References: