University of Pennsylvania
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).
Twenty eligible patients with mild to moderately active RP within 60 days prior to screening will be enrolled to the study. Subjects will be eligible to enroll into stage 1 if they are naïve to methotrexate (MTX) or azathioprine (AZA), or having active disease on MTX or AZA for 8 weeks or less. Patients naïve to MTX and AZA will be started on MTX. AZA will be started if there is a contraindication to MTX. Patients on MTX/AZA for 8 weeks or less with active disease will be continued with the respective medication. Patients who do not meet primary effectiveness end point in Stage 1 or develop…
Inclusion Criteria: 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: 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 Damiani's Criteria (1979) 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 g…
Weekly methotrexate dose of 20 mg (oral or subcutaneous).
Azathioprine dose will be 2-3 mg/kg body weight per day.
Adalimumab dose will be 40 mg subcutaneously every 1-2 weeks
Infliximab dose will be 5mg/kg at week 0 and week 2, and then every 4-8 weeks.
Tocilizumab dose will be 162 mg subcutaneous injection every week or 4-8 mg/kg every 4 weeks
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