NCT04919538

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
45mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Feb 2021Jan 2030

Study Start

First participant enrolled

February 26, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

8.9 years

First QC Date

May 11, 2021

Last Update Submit

January 21, 2026

Conditions

VasculitisRelapsing Polychondritis

Keywords

RP

Outcome Measures

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.

    Study completion; from baseline through month 36.

Secondary Outcomes (4)

  • PROMIS Questionnaires

    Baseline, month 6, month 12, month 18, month 24, month 30, month 36

  • PROMIS Questionnaires

    Baseline, month 6, month 12, month 18, month 24, month 30, month 36

  • PROMIS Questionnaires

    Baseline, month 6, month 12, month 18, month 24, month 30, month 36

  • PROMIS Questionnaires

    Baseline, month 6, month 12, month 18, month 24, month 30, month 36

Study Arms (1)

Relapsing Polychondritis Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \. Inability to provide consent, or in the case of minors, assent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Polychondritis, RelapsingVasculitis

Condition Hierarchy (Ancestors)

Cartilage DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Peter Merkel, MD, MPH

    University of Pennsylvania

    STUDY DIRECTOR

  • Shubhasree Banerjee, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol McAlear

CONTACT

7813214567cmcalear@upenn.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2021

First Posted

June 9, 2021

Study Start

February 26, 2021

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)