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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Self-administered with auto injector
Prefilled syringe administered by study staff
Regeneron Research Facility
Gilbert, Arizona, United States
Regeneron Research Facility
Glendale, Arizona, United States
Regeneron Research Facility
Los Angeles, California, United States
Regeneron Research Facility
Wheat Ridge, Colorado, United States
Regeneron Research Facility
Ocala, Florida, United States
Regeneron Research Facility
Orlando, Florida, United States
Regeneron Research Facility
Pinellas Park, Florida, United States
Regeneron Research Facility
Port Orange, Florida, United States
Regeneron Research Facility
Atlanta, Georgia, United States
Regeneron Research Facility
West Des Moines, Iowa, United States
...and 13 more locations
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
Time frame: Baseline to Week 16
Proportion of successful fasinumab injections administered by patients or their caregivers using an AI in an unsupervised setting (per patient report)
Time frame: Baseline to Week 16
Number of AI associated product technical complaint (PTCs)
Time frame: Baseline to Week 16
Number of validated AI associated PTFs
Time frame: Baseline to Week 16
Number of patients with an AI associated PTC
Time frame: Baseline to Week 16
Number of AI use-related errors
Including but not limited to improper storage, inappropriate use of the device, dosing schedule mistakes, and user handling mistakes
Time frame: Baseline to Week 16
Patient satisfaction with the AI as assessed using the Self-Injection Assessment Questionnaire (SIAQ)
Time frame: Baseline to Week 16
Number of participants who experience Adjudicated arthropathy (AA)
As confirmed by independent adjudication
Time frame: Through week 36
Number of participants who experience Destructive arthropathy (DA)
As confirmed by independent adjudication
Time frame: Through week 36
Number of participants who experience treatment-emergent adverse events (TEAEs)
Time frame: Through week 16
Number of participants who experience sympathetic nervous system dysfunction
Time frame: Through week 36
Number of participants who experience peripheral sensory adverse events (AEs) that require a neurology or other specialty consultation
Time frame: Through week 36
Number of participants who experience all-cause Joint replacement (JR)s
Time frame: Through week 36
Number of participants who experienced JR at the telephone survey
Time frame: 52 weeks after last dose of study drug
Maximum observed drug concentration (Cmax)
Time frame: Up to 36 weeks
Area under the curve from the time of dosing to the end of dosing interval (AUC)
Time frame: Up to 36 weeks
Geometric mean ratio of Cmax and AUC for the AI device (CI) of the geometric mean ratio
Time frame: Up to 36 weeks
Geometric mean ratio of Cmax and AUC for the PFS device (CI) of the geometric mean ratio
Time frame: Up to 36 weeks
Incidence of anti-drug antibody (ADA)
Time frame: Up to 36 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.