Relapsing PolychondritisNCT04919538
Longitudinal Study for Relapsing Polychondritis
An observational study of Relapsing Polychondritis and Vasculitis, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Relapsing Polychondritis, Vasculitis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with relapsing polychondritis (RP). Enrollment will be sequential and participants will have disease in various stages and of different duration.
Who may be able to join
- 1. Any subject considered to have a diagnosis of relapsing polychondritis according to the investigator.
Who cannot join
- 1. Inability to provide consent, or in the case of minors, assent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jessica Nguyen, Jessica.Nguyen2@PennMedicine.upenn.edu
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. 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.
- Conditions
- Relapsing Polychondritis, Vasculitis
- Keywords
- RP
- Medical subject headings
- Polychondritis, Relapsing, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Relapsing Polychondritis Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the pathogenesis of relapsing polychondritis using disease history.
To study the manner of development of disease in patients affected with relapsing polychondritis.
Measured: Study completion; from baseline through month 36.
Secondary outcomes (4)
PROMIS Questionnaires
Questions will ask about fatigue on the PROMIS short form.
Measured: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Questions will ask about pain interference on the PROMIS short form.
Measured: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Questions will ask about physical function on the PROMIS short form.
Measured: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Questions will ask about global health on the PROMIS short form.
Measured: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start26 Feb 2021
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing PolychondritisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Merkel, MD, MPH, Study director, University of PennsylvaniaShubhasree Banerjee, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919538
- Sponsor's protocol ID
- VCRC5508
- Status last verified
- Jan 2026
- First submitted
- 11 May 2021
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study for Relapsing Polychondritis
- ClinicalTrials.gov ID
- NCT04919538
- Acronym / sponsor ID
- VCRC5508
- Conditions
- Relapsing Polychondritis, Vasculitis
- Keywords
- RP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsing Polychondritis Cohort | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with relapsing polychondritis (RP). Enrollment will be sequential and participants will have disease in various stages and of different duration.
Key inclusion criteria (1 listed)
- 1. Any subject considered to have a diagnosis of relapsing polychondritis according to the investigator.
Key exclusion criteria (1 listed)
- 1. Inability to provide consent, or in the case of minors, assent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
PROMIS Questionnaires
Time frame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Time frame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Time frame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Time frame: Baseline, month 6, month 12, month 18, month 24, month 30, month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Relapsing Polychondritis FoundationLink provided by the sponsor.
- Vasculitis Clinical Research ConsortiumLink provided by the sponsor.
- Rare Diseases Clinical Research Network (RDCR)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Merkel, MD, MPH study director
University of Pennsylvania
Shubhasree Banerjee, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Polychondritis and Vasculitis, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol McAlear (7813214567, cmcalear@upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the pathogenesis of relapsing polychondritis using disease history. (time frame: Study completion; from baseline through month 36.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.