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).
Bilateral auricular chondritis
Non-erosive seronegative polyarthritis
Nasal chondritis
Ocular inflammation
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.
ANCA-associated vasculitis
Crossover
Methotrexate (MTX)
DrugWeekly methotrexate dose of 20 mg (oral or subcutaneous).
Azathioprine (AZA)
DrugAzathioprine dose will be 2-3 mg/kg body weight per day.
Adalimumab
Biological/VaccineAdalimumab dose will be 40 mg subcutaneously every 1-2 weeks
Infliximab
Biological/VaccineInfliximab dose will be 5mg/kg at week 0 and week 2, and then every 4-8 weeks.
Tocilizumab
Biological/VaccineTocilizumab dose will be 162 mg subcutaneous injection every week or 4-8 mg/kg every 4 weeks
Efficacy of the study drugs for the treatment of relapsing polychondritis.
The proportion of subjects in remission at week 26
Physician's global assessment of response
Health-related quality of life as measured using physician's global assessment scale.
Response rates for each of the study drugs
Proportion of patient with complete response and significant response to therapy at weeks 12 and 26
Patient's global assessment of response
Health-related quality of life as measured using patient's global assessment scale.
Health-related quality of life
Health-related quality of life as measured using SF-36
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