Longitudinal Study for Relapsing Polychondritis

NCT ID: NCT04919538

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-26

Study Completion Date

2030-01-31

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.

Conditions

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Relapsing Polychondritis Vasculitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Relapsing Polychondritis Cohort

No interventions assigned to this group

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Merkel, MD, MPH

Role: STUDY_DIRECTOR

University of Pennsylvania

Shubhasree Banerjee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carol McAlear

Role: CONTACT

7813214567

Facility Contacts

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Jessica Nguyen

Role: primary

Related Links

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https://polychondritis.org

Relapsing Polychondritis Foundation

https://www.rarediseasesnetwork.org/vcrc

Vasculitis Clinical Research Consortium

http://www.rarediseasesnetwork.org/

Rare Diseases Clinical Research Network (RDCR)

Other Identifiers

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VCRC5508

Identifier Type: -

Identifier Source: org_study_id

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