To Assess the Patients' Ability to Self-Administer Fasinumab
Status:
Completed
Trial end date:
2020-12-15
Target enrollment:
Participant gender:
Summary
The primary objective is to demonstrate that the auto-injector(AI) is suitable to be used to
administer fasinumab at home by patients or their caregivers, as measured by collecting 12
weeks of actual-use data on the technical performance of the device.
The secondary objectives of the study are:
- To evaluate the successful injection of fasinumab by patients or their caregivers using
the AI in an unsupervised setting
- To evaluate patient/caregiver satisfaction with the AI for fasinumab injection in an
unsupervised setting
- To evaluate exposure in serum for fasinumab administered by patients or their caregivers
using an AI in an unsupervised setting, or fasinumab administered by study staff using a
PFS that has been used in the phase 3 program
- To characterize the safety, tolerability, and immunogenicity of fasinumab administered
by patients or their caregivers using an AI in an unsupervised setting, or fasinumab
administered by study staff using a PFS that has been used in the phase 3 program