Last updated on November 2019

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


Brief description of study

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.

Detailed Study Description

Study duration per participant is approximative 62 weeks including up to a 4-week screening period, 52-week treatment period and 6-week follow-up period.

Clinical Study Identifier: NCT03600818

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Investigational Site Number 0320003

San Miguel de Tucuman, Argentina
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Investigational Site Number 6430008

Saint-Petersburg, Russian Federation
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