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Longitudinal Study for Relapsing Polychondritis

Longitudinal Study for Relapsing Polychondritis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04919538
Enrollment
100
Registered
2021-06-09
Start date
2021-02-26
Completion date
2030-01-01
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Polychondritis, Vasculitis

Keywords

RP

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.

Interventions

None listed

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
PROMIS QuestionnairesBaseline, month 6, month 12, month 18, month 24, month 30, month 36Questions will ask about fatigue on the PROMIS short form.

Countries

United States

Contacts

CONTACTCarol McAlear
cmcalear@upenn.edu7813214567
STUDY_DIRECTORPeter Merkel, MD, MPH

University of Pennsylvania

PRINCIPAL_INVESTIGATORShubhasree Banerjee, MD

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026