To Assess the Patients' Ability to Self-Administer Fasinumab

Completed · Phase 1

Conditions studied: Osteoarthritis, Knee, Osteoarthritis, Hip

In brief

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

Key facts

Study ID
NCT03491904
Run by
Regeneron Pharmaceuticals
People needed
100
Starts
2019-01-23
Expected to finish
2020-12-15
Last updated by the study team
2021-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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