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RecruitingNCT04919538Updated Jan 23, 2026

Longitudinal Study for Relapsing Polychondritis

An observational study in Relapsing Polychondritis and Vasculitis, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by University of Pennsylvania · Observational

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Relapsing Polychondritis
  • Vasculitis

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Keywords

  • RP
03

In context

Vasculitis

170 studies on the registry are indexed under Vasculitis; 46 are open to participants now.

This study's planned enrollment of 100 is below the median of 147 across 77 observational studies indexed under Vasculitis.

Browse Vasculitis studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Any subject considered to have a diagnosis of relapsing polychondritis according to the investigator.

Exclusion criteria

Exclusion Criteria:

  • 1. Inability to provide consent, or in the case of minors, assent.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Relapsing Polychondritis Cohort
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What researchers measure

Primary outcomes

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

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

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

Secondary outcomes

  1. PROMIS Questionnaires

    Questions will ask about fatigue on the PROMIS short form.

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

  2. PROMIS Questionnaires

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

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

  3. PROMIS Questionnaires

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

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

  4. PROMIS Questionnaires

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

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

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Study locations

1 of 1 sites recruiting
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04919538
Responsible party
Sponsor
First posted
Jun 9, 2021
Start date
Feb 26, 2021
Primary completion
Jan 2030 (estimated)
Completion
Jan 2030 (estimated)
Last update
Jan 23, 2026

Study contacts

Carol McAlear
Contact
cmcalear@upenn.edu
7813214567
Peter Merkel, MD, MPH
study director · University of Pennsylvania
Shubhasree Banerjee, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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