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 relapse of RP or intolerance to MTX/AZA will move to Stage 2. Patients eligible to be enrolled to Stage 2 directly 1. History of intolerance or side effects to MTX or AZA with active disease 2. Currently on MTX or AZA for at least 8 weeks or has received it within the past 60 days for at least 8 weeks and still has mild/ moderate active disease All patients in Stage 2 will be started on Tumor necrosis factor inhibitor (TNFi) or Interleukin 6 inhibitor (IL6i). The two TNFis that will be used in the trial are adalimumab or infliximab. The choice between the 2 TNFis will be based on patients' preference/ feasibility. The IL6i in the study will be tocilizumab. All patients will receive glucocorticoids (GC) which will be tapered to 5 mg daily by week 21 according to a standardized schedule in both stages of the trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGEfficacy of the study drugs for the treatment of relapsing polychondritis.
The proportion of subjects in remission at week 26
Time frame: 26 weeks
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
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
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
Health-related quality of life
Health-related quality of life as measured using SF-36
Time frame: Assessed at weeks 0, 12, and 26
Time to disease flare
Disease flare defined as increase on a disease activity instrument by at least 1 point
Time frame: 26 weeks
Safety of study drugs in RP
Safety of study drugs in patients with RP as assessed by reported adverse events.
Time frame: 26 weeks
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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