MedTrace Logo

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

NCT03600818 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2022-06-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Polymyalgia Rheumatica

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-09
Primary Completion
2021-05-19
Completion
2021-05-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Estonia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03600818 on ClinicalTrials.gov