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NCT Number: NCT04919538

Longitudinal Study for Relapsing Polychondritis

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Jessica Nguyen

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evaluate the pathogenesis of relapsing polychondritis using disease history.

    Time frame: Study completion; from baseline through month 36.

    To study the manner of development of disease in patients affected with relapsing polychondritis.

Secondary outcomes

  1. PROMIS Questionnaires

    Time frame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36

    Questions will ask about fatigue on the PROMIS short form.

  2. PROMIS Questionnaires

    Time frame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36

    Questions will ask about pain interference on the PROMIS short form.

  3. PROMIS Questionnaires

    Time frame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36

    Questions will ask about physical function on the PROMIS short form.

  4. PROMIS Questionnaires

    Time frame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36

    Questions will ask about global health on the PROMIS short form.

Study contacts

Contact information is provided by the study sponsor or research team.

Carol McAlear

CONTACT

[email protected]

7813214567

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Jun 9, 2021
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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