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

NCT06941376 | Recruiting Phase 2 FDA Drug

• 1 other identifier: VCRC5565
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Relapsing Polychondritis

Keywords

Relapsing Polychondritis; RP; Vasculitis; Polychondritis, relapsing

Outcome Measures

Primary Outcomes (1)

• Efficacy of the study drugs for the treatment of relapsing polychondritis.

  The proportion of subjects in remission at week 26

  26 weeks

Secondary Outcomes (6)

• Physician's global assessment of response

  Assessed at weeks 0, 12, and 26

• Response rates for each of the study drugs

  Response evaluated weeks 12 and 26

• Patient's global assessment of response

  Assessed at weeks 0, 12, and 26

• Health-related quality of life

  Assessed at weeks 0, 12, and 26

• Time to disease flare

  26 weeks

Study Arms (2)

Azathioprine or Methotrexate

EXPERIMENTAL

Drug: Methotrexate (MTX); Drug: Azathioprine (AZA)

Adalimumab, Infliximab, or Tocilizumab

EXPERIMENTAL

Biological: Adalimumab; Biological: Infliximab; Biological: Tocilizumab

Interventions

Adalimumab BIOLOGICAL

Adalimumab dose will be 40 mg subcutaneously every 1-2 weeks

Adalimumab, Infliximab, or Tocilizumab

Infliximab BIOLOGICAL

Infliximab dose will be 5mg/kg at week 0 and week 2, and then every 4-8 weeks.

Adalimumab, Infliximab, or Tocilizumab

Tocilizumab BIOLOGICAL

Tocilizumab dose will be 162 mg subcutaneous injection every week or 4-8 mg/kg every 4 weeks

Adalimumab, Infliximab, or Tocilizumab

Methotrexate (MTX) DRUG

Weekly methotrexate dose of 20 mg (oral or subcutaneous).

Azathioprine or Methotrexate

Azathioprine (AZA) DRUG

Azathioprine dose will be 2-3 mg/kg body weight per day.

Azathioprine or Methotrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. ≥18 years of age
• B. Must fulfill McAdam's or Damiani's or Michet's Criteria Diagnostic Criteria for Relapsing Polychondritis McAdam's Criteria (1976)
• ≥ 3 criteria out of 6 of the following:
• Bilateral auricular chondritis
• Non-erosive seronegative polyarthritis
• Nasal chondritis
• Ocular inflammation
• Respiratory tract chondritis
• Cochlear and/or vestibular dysfunction
• Damiani's Criteria (1979)
• ≥3 of McAdam's Criteria as above
• ≥1 of McAdam's Criteria with histological confirmation of chondritis
• ≥2 of McAdam's Criteria with positive response to glucocorticoids or dapsone
• Michet's Criteria (1986)
• Presence of ≥2 of the following criteria:

You may not qualify if:

• A. Severe disease manifestations within the past 28 days, including:
• 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.
• Central nervous system (CNS) disease (meningitis, encephalitis, optic neuritis) requiring hospitalization/ treatment with intravenous methylprednisolone/ cyclophosphamide.
• Cardiac disease (symptomatic valve dysfunction, heart failure) requiring active treatment for heart failure/ hospitalization/ consideration for surgery.
• Severe ophthalmologic manifestations: severe scleritis, uveitis, retinal vasculitis, optic neuritis which is imminently vision threatening.
• Any disease manifestation considered organ/ life-threatening felt to require treatment with prednisone\>60 mg/ day or IV methylprednisolone or cyclophosphamide.
• B. Patients with current/ prior use of methotrexate or azathioprine will be eligible for stage 1 or stage 2 of the study depending on the duration of treatment with the non- biologic DMARD treatment.
• C. Patients with exposure to biologic DMARDS will be excluded.
• D. Evidence of active infection.
• E. Known infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B surface antigen.
• F. Patients at risk for tuberculosis (TB) defined as follows:
• 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.
• 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.
• 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.
• G. Inability to comply with study guidelines.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Polychondritis, Relapsing; Vasculitis

Interventions

Methotrexate; Azathioprine; Adalimumab; Infliximab; tocilizumab

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shubhasree Banerjee, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol McAlear

CONTACT

781-321-4567; cmcalear@upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)