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Fasinumab AI · FACT DEVICE

To Assess the Patients' Ability to Self-Administer Fasinumab

Ensayo de REGENERON PHARMACEUTICALS, INC. en Osteoarthritis, Knee · Osteoarthritis, Hip (del registro, en inglés).

Más ensayos de: Artrosis de rodilla.

Fase

Fase 1

Estado

Completado

Participantes

100

previstos

Centros

23

Fin del objetivo primario

ene 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en ene 2019.

Qué mide

Percentage of device-associated product technical failure (PTF) for the AI based on the total number of fasinumab injections administered by patients/caregivers in an unsupervised setting (del registro, en inglés) (del inicio a la semana 16)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03491904), actualizada en mar 2021.