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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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).

Eligibility criteria

Qualifiers

Bilateral auricular chondritis

Non-erosive seronegative polyarthritis

Nasal chondritis

Ocular inflammation

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Methotrexate (MTX)
  • Azathioprine (AZA)
  • Adalimumab
  • Infliximab
  • Tocilizumab

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators