Health TrialsbyHealthPanel

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

ConditionRelapsing 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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Methotrexate (MTX)

    Drug

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

  • Azathioprine (AZA)

    Drug

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

  • Adalimumab

    Biological/Vaccine

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

  • Infliximab

    Biological/Vaccine

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

  • Tocilizumab

    Biological/Vaccine

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Azathioprine or MethotrexateExperimental treatment 2 interventions
Group B: Adalimumab, Infliximab, or TocilizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

The proportion of subjects in remission at week 26

Time frame
26 weeks

Secondary outcomes

1

Physician's global assessment of response

Health-related quality of life as measured using physician's global assessment scale.

Time frame
Assessed at weeks 0, 12, and 26
2

Response rates for each of the study drugs

Proportion of patient with complete response and significant response to therapy at weeks 12 and 26

Time frame
Response evaluated weeks 12 and 26
3

Patient's global assessment of response

Health-related quality of life as measured using patient's global assessment scale.

Time frame
Assessed at weeks 0, 12, and 26
4

Health-related quality of life

Health-related quality of life as measured using SF-36

Time frame
Assessed at weeks 0, 12, and 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
Apply now