RECRUITING

An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis

Conditions

Relapsing Polychondritis RP Vasculitis Polychondritis, relapsing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Open label pragmatic two-stage non-randomized trial comparing the effectiveness of five different standard of care treatment options for patients with relapsing polychondritis (RP).

Official Title

Pragmatic, Open-Label, Two-Stage, Pilot Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis

Quick Facts

Study Start:2025-08-01

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06941376

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Bilateral auricular chondritis 2. Non-erosive seronegative polyarthritis 3. Nasal chondritis 4. Ocular inflammation 5. Respiratory tract chondritis 6. Cochlear and/or vestibular dysfunction 1. ≥3 of McAdam's Criteria as above 2. ≥1 of McAdam's Criteria with histological confirmation of chondritis 3. ≥2 of McAdam's Criteria with positive response to glucocorticoids or dapsone 1. Auricular chondritis 2. Nasal chondritis 3. Laryngotracheal chondritis 1. Seronegative inflammatory arthritis 2. Ocular inflammation 3. Hearing loss 4. Vestibular dysfunction 1. Auricular inflammation: defined as increase/ new onset pain/ swelling/redness of external ear(s), ear canal 2. Nasal inflammation: defined as increase/ new onset pain/ swelling/redness of external nose 3. Ocular inflammation: defined as new onset/ worsening unilateral/ bilateral episcleritis/scleritis/ uveitis. 4. Inflammatory arthritis: defined as new onset/ worsening morning stiffness≥30 minutes, physician diagnosed tenderness/swelling in ≥1 joint; new onset/ worsening costochondritis. 5. Mild to moderate airway inflammation: defined as new onset/ worsening mild to moderate inflammation of upper airway diagnosed by direct laryngoscopy and attributed to RP; abnormal CT airway/ bronchoscopy showing wall thickening of airway (larynx, trachea, bronchi) and absence of severe manifestations such as new onset SGS/tracheomalacia/ bronchomalacia. 6. Sinonasal disease: defined as new onset/ increase in nasal crusting, discharge bleeding 7. Constitutional symptoms: defined as new onset/ worsening fever, unintentional weight loss of ≥ 5% of body weight, night sweats Patients must have at least 1 of the first 5 criteria within the past 60 days prior to the enrollment.	1. Severe airway inflammation with supplemental oxygen requirement, tracheostomy, airway stenting, ventilation. Patients with prior history of severe airway disease, who currently have damage will be eligible if they have mild- moderate active disease within the past 60 days at the time of enrollment. 2. Central nervous system (CNS) disease (meningitis, encephalitis, optic neuritis) requiring hospitalization/ treatment with intravenous methylprednisolone/ cyclophosphamide. 3. Cardiac disease (symptomatic valve dysfunction, heart failure) requiring active treatment for heart failure/ hospitalization/ consideration for surgery. 4. Severe ophthalmologic manifestations: severe scleritis, uveitis, retinal vasculitis, optic neuritis which is imminently vision threatening. 5. Any disease manifestation considered organ/ life-threatening felt to require treatment with prednisone\>60 mg/ day or IV methylprednisolone or cyclophosphamide. 1. Current clinical, radiographic or laboratory evidence of active TB, even if currently being treated. Chest x-rays (posterior/anterior and lateral) obtained within the 6 months prior to screening and TB testing (IFN gamma release assay or PPD) performed in the past month prior to screening will be accepted; however, a copy of the reports must be placed in the participant binder. 2. A history of active TB unless there is documentation that the patient had received prior anti-TB treatment that was appropriate in duration and type according to local health authority guidelines. 3. Patients with a positive TB screening test indicative of latent TB will not be eligible for the study unless they: i. Have no evidence of current TB based on chest x-ray performed during the screening period and by history and physical exam, and ii. They are currently being treated for latent TB or the site has documentation of successful prior treatment of latent TB. Treatment regimens should be dictated by local guidelines as long as the treatment dose and duration meet or exceed local health authority guidelines. Patients with latent TB may be eligible for the trial prior to completion of treatment as long as they have completed at least 4 weeks of treatment and they have no evidence of current TB on chest x-ray at screening. 1. ANCA-associated vasculitis 2. Polyarteritis nodosa 3. Giant cell arteritis 4. Takayasu's arteritis 5. Cogan's syndrome 6. Sarcoidosis 7. Kawasaki disease 8. Tuberculosis or atypical mycobacterial infections 9. Deep fungal infections 10. Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis 11. Cryoglobulinemic vasculitis 12. Systemic lupus erythematosus 13. Rheumatoid arthritis 14. Overlap with other autoimmune diseases 15. Diagnosis of VEXAS syndrome

Inclusion Criteria

Exclusion Criteria

1. Bilateral auricular chondritis
2. Non-erosive seronegative polyarthritis
3. Nasal chondritis
4. Ocular inflammation
5. Respiratory tract chondritis
6. Cochlear and/or vestibular dysfunction
1. ≥3 of McAdam's Criteria as above
2. ≥1 of McAdam's Criteria with histological confirmation of chondritis
3. ≥2 of McAdam's Criteria with positive response to glucocorticoids or dapsone
1. Auricular chondritis
2. Nasal chondritis
3. Laryngotracheal chondritis
1. Seronegative inflammatory arthritis
2. Ocular inflammation
3. Hearing loss
4. Vestibular dysfunction
1. Auricular inflammation: defined as increase/ new onset pain/ swelling/redness of external ear(s), ear canal
2. Nasal inflammation: defined as increase/ new onset pain/ swelling/redness of external nose
3. Ocular inflammation: defined as new onset/ worsening unilateral/ bilateral episcleritis/scleritis/ uveitis.
4. Inflammatory arthritis: defined as new onset/ worsening morning stiffness≥30 minutes, physician diagnosed tenderness/swelling in ≥1 joint; new onset/ worsening costochondritis.
5. Mild to moderate airway inflammation: defined as new onset/ worsening mild to moderate inflammation of upper airway diagnosed by direct laryngoscopy and attributed to RP; abnormal CT airway/ bronchoscopy showing wall thickening of airway (larynx, trachea, bronchi) and absence of severe manifestations such as new onset SGS/tracheomalacia/ bronchomalacia.
6. Sinonasal disease: defined as new onset/ increase in nasal crusting, discharge bleeding
7. Constitutional symptoms: defined as new onset/ worsening fever, unintentional weight loss of ≥ 5% of body weight, night sweats Patients must have at least 1 of the first 5 criteria within the past 60 days prior to the enrollment.

1. Severe airway inflammation with supplemental oxygen requirement, tracheostomy, airway stenting, ventilation. Patients with prior history of severe airway disease, who currently have damage will be eligible if they have mild- moderate active disease within the past 60 days at the time of enrollment.
2. Central nervous system (CNS) disease (meningitis, encephalitis, optic neuritis) requiring hospitalization/ treatment with intravenous methylprednisolone/ cyclophosphamide.
3. Cardiac disease (symptomatic valve dysfunction, heart failure) requiring active treatment for heart failure/ hospitalization/ consideration for surgery.
4. Severe ophthalmologic manifestations: severe scleritis, uveitis, retinal vasculitis, optic neuritis which is imminently vision threatening.
5. Any disease manifestation considered organ/ life-threatening felt to require treatment with prednisone\>60 mg/ day or IV methylprednisolone or cyclophosphamide.
1. Current clinical, radiographic or laboratory evidence of active TB, even if currently being treated. Chest x-rays (posterior/anterior and lateral) obtained within the 6 months prior to screening and TB testing (IFN gamma release assay or PPD) performed in the past month prior to screening will be accepted; however, a copy of the reports must be placed in the participant binder.
2. A history of active TB unless there is documentation that the patient had received prior anti-TB treatment that was appropriate in duration and type according to local health authority guidelines.
3. Patients with a positive TB screening test indicative of latent TB will not be eligible for the study unless they: i. Have no evidence of current TB based on chest x-ray performed during the screening period and by history and physical exam, and ii. They are currently being treated for latent TB or the site has documentation of successful prior treatment of latent TB. Treatment regimens should be dictated by local guidelines as long as the treatment dose and duration meet or exceed local health authority guidelines. Patients with latent TB may be eligible for the trial prior to completion of treatment as long as they have completed at least 4 weeks of treatment and they have no evidence of current TB on chest x-ray at screening.
1. ANCA-associated vasculitis
2. Polyarteritis nodosa
3. Giant cell arteritis
4. Takayasu's arteritis
5. Cogan's syndrome
6. Sarcoidosis
7. Kawasaki disease
8. Tuberculosis or atypical mycobacterial infections
9. Deep fungal infections
10. Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis
11. Cryoglobulinemic vasculitis
12. Systemic lupus erythematosus
13. Rheumatoid arthritis
14. Overlap with other autoimmune diseases
15. Diagnosis of VEXAS syndrome

Contacts and Locations

Study Contact

Carol McAlear

CONTACT

781-321-4567

cmcalear@upenn.edu

Principal Investigator

Shubhasree Banerjee, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Shubhasree Banerjee, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-08-01

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Relapsing Polychondritis
RP
Vasculitis
Polychondritis, relapsing

Additional Relevant MeSH Terms

Relapsing Polychondritis