Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
Status:
Terminated
Trial end date:
2021-05-19
Target enrollment:
Participant gender:
Summary
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.