ClinicalTrials.gov record NCT04919538
Longitudinal Study for Relapsing Polychondritis
Longitudinal Study for Relapsing Polychondritis
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study follows people with relapsing polychondritis (and related vasculitis) over time to study how the disease develops. Visits occur every 6 months or yearly, with blood and urine collected, a physical exam, medical and medication history, and questionnaires about symptoms and health. Participants may be followed through month 36. The study aims to learn more about the disease's biology and course.
What it is studying. The study is testing (observing) the pathogenesis of relapsing polychondritis — how the disease develops and affects the body over time.
What the researchers hope to learn. To generate new insights into the immunology, mechanisms, and trajectory of inflammation in relapsing polychondritis and to inform future diagnostic and treatment research.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Any subject considered to have a diagnosis of relapsing polychondritis according to the investigator.
Exclusion criteria
- Inability to provide consent, or in the case of minors, assent.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will attend study visits every 6 months or annually. At each visit they will give blood and urine samples, have a physical exam, and provide medical and medication history. They will complete questionnaires about disease activity, health status, and tobacco, alcohol, and drug use; PROMIS questionnaires are scheduled at baseline and at months 6, 12, 18, 24, 30, and 36. The registry record does not list other invasive procedures.
How the study is structured. This is a prospective observational cohort study: all participants join a single group and are followed over time (up to month 36). Study visits are scheduled every 6 months or annually; at each visit participants provide blood and urine samples, undergo a physical exam with medical and medication history, and complete questionnaires (including PROMIS forms on fatigue, pain, physical function, and global health). There are no assigned treatments or comparison groups.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on relapsing polychondritis
Important dates
- Study start
- Feb 26, 2021
- Primary completion
- January 2030 (estimated)
- Study completion
- January 2030 (estimated)
- Target enrollment
- 100 participants (estimated)
- Last updated on registry
- Jan 23, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University of Pennsylvania
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Carol McAlear 📞 7813214567 ✉ cmcalear@upenn.edu
Participating sites (1)
- University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, 19104 · United States
- Jessica Nguyen · Jessica.Nguyen2@PennMedicine.upenn.edu
Terms used on this page · explanations by MedicalUpdates.ai
- assent
- A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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