NCT03600818

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

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants 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 participants with PMR 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 participants with PMR. * To measure sarilumab serum concentrations in participants with PMR. * To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.

Detailed description

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

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Sarilumab SAR153191 (REGN88)	Pharmaceutical form:solution for injection Route of administration: subcutaneous
DRUG	Sarilumab-matching placebo	Pharmaceutical form:solution for injection Route of administration: subcutaneous
DRUG	Prednisone	Pharmaceutical form:over-encapsulated tablets Route of administration: oral administration
DRUG	Prednisone-matching placebo	Pharmaceutical form:over-encapsulated tablets Route of administration: oral administration
DRUG	Prednisone	Pharmaceutical form:tablets Route of administration: oral administration

Timeline

• Start date: 2018-10-09
• Primary completion: 2021-05-19
• Completion: 2021-05-19
• First posted: 2018-07-26
• Last updated: 2022-06-10
• Results posted: 2022-06-10

Locations

84 sites across 17 countries: United States, Argentina, Australia, Belgium, Canada, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Russia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study