Who is sponsoring FACT DEVICE?

FACT DEVICE is sponsored by Regeneron Pharmaceuticals.

What condition does FACT DEVICE study?

FACT DEVICE studies Osteoarthritis, Knee, Osteoarthritis, Hip.

What drugs are being tested in FACT DEVICE?

Interventions: Fasinumab AI, Fasinumab PFS.

What is the status of FACT DEVICE?

FACT DEVICE is currently COMPLETED.

Last reviewed 2021-03-03 · How we verify

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

NCT03491904 PHASE1 COMPLETED

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

Details

Lead sponsor	Regeneron Pharmaceuticals
Phase	PHASE1
Status	COMPLETED
Enrolment	100
Start date	Wed Jan 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Dec 15 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Osteoarthritis, Knee
Osteoarthritis, Hip

Interventions

Fasinumab AI
Fasinumab PFS

Countries

United States