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To Assess the Patients' Ability to Self-Administer Fasinumab — FACT DEVICE  

Osteoarthritis, Knee Clinical Trial

Official title:
A Phase 1, Multicenter, Randomized, Open-Label, Parallel-Group, Multi-Dose Study in Patients With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee or Hip to Assess the Patients' Ability to Self-Administer Fasinumab Using an Auto-Injector and to Characterize the Pharmacokinetics of Fasinumab Using Two Different Presentations

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03491904
Study type Interventional
Source Regeneron Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date January 23, 2019
Completion date December 15, 2020
View Details
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