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Open Study: Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

Brief Summary:  March 20, 2020

Primary Objective:

To evaluate the efficacy of KEVZARA (sarilumab) in patients with polymyalgia rheumatica (PMR) as assessed by the proportion of subjects with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen.

Secondary Objectives:

  • To demonstrate the efficacy of sarilumab in patients with polymyalgia rheumatica compared to placebo, in combination with a CS taper with regards to:
  • Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time.
  • Cumulative CS (including prednisone) exposure.
  • To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with PMR.
  • To measure sarilumab serum concentrations in patients with PMR.
  • To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.
    Click here to learn more about this study.
    ClinicalTrials.gov Identifier: NCT03600818