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Longitudinal Study for Relapsing Polychondritis

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04919538
Collaborator
(none)
100
Enrollment
1
Location
34.1
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Longitudinal Study for Relapsing Polychondritis
    Actual Study Start Date :
    Feb 26, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Relapsing Polychondritis Cohort

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the pathogenesis of relapsing polychondritis using disease history. [Study completion; from baseline through month 36.]

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

    Secondary Outcome Measures

    1. PROMIS Questionnaires [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 [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 [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 [Baseline, month 6, month 12, month 18, month 24, month 30, month 36]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT04919538
    Other Study ID Numbers:
    • VCRC5508
    First Posted:
    Jun 9, 2021
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Pennsylvania
    RP
    Additional relevant MeSH terms:
    Polychondritis, Relapsing
    Vasculitis

    Study Results

    No Results Posted as of Jul 12, 2022