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.

Study Overview

• Status: Recruiting
• Conditions: Vasculitis; Relapsing Polychondritis

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Carol McAlear; Phone Number: 7813214567; Email: cmcalear@upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Jessica Nguyen; Email: Jessica.Nguyen2@PennMedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Relapsing Polychondritis Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the pathogenesis of relapsing polychondritis using disease history.	To study the manner of development of disease in patients affected with relapsing polychondritis.	Study completion; from baseline through month 36.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Questionnaires	Questions will ask about fatigue on the PROMIS short form.	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.	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.	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.	Baseline, month 6, month 12, month 18, month 24, month 30, month 36

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Study Director: Peter Merkel, MD, MPH, University of Pennsylvania; Principal Investigator: Shubhasree Banerjee, MD, University of Pennsylvania

Publications and helpful links

Helpful Links

• Relapsing Polychondritis Foundation
• Vasculitis Clinical Research Consortium
• Rare Diseases Clinical Research Network (RDCR)

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: RP
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Connective Tissue Diseases; Cartilage Diseases; Skin and Connective Tissue Diseases; Polychondritis, Relapsing; Vasculitis
• Other Study ID Numbers: VCRC5508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No