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NCT03491904 · ClinicalTrials.gov registry record · Phase 1
To Assess the Patients' Ability to Self-Administer Fasinumab
A Phase 1 study of Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT03491904 is a Phase 1 study of Osteoarthritis, Knee and Osteoarthritis, Hip that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 100 participants, below the 579-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT03491904, a Phase 1 study of Osteoarthritis, Knee and Osteoarthritis, Hip, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Fasinumab AI
- DRUG Fasinumab PFS
Study Locations (20)
Florida
- Regeneron Research Facility - Ocala
- Regeneron Research Facility - Orlando
- Regeneron Research Facility - Pinellas Park
- Regeneron Research Facility - Port Orange
Arizona
- Regeneron Research Facility - Gilbert
- Regeneron Research Facility - Glendale
Kentucky
- Regeneron Research Facility - Lexington
- Regeneron Research Facility - Lexington
North Carolina
- Regeneron Research Facility - Statesville
- Regeneron Research Facility - Wilmington
Tennessee
- Regeneron Research Facility - Bristol
- Regeneron Research Facility - Knoxville
California
- Regeneron Research Facility - Los Angeles
Colorado
- Regeneron Research Facility - Wheat Ridge
Georgia
- Regeneron Research Facility - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-01-23 |
| Est. Completion | 2020-12-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03491904
The ClinicalTrials.gov registry entry for NCT03491904 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 579-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (83% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions - of which Fasinumab AI is the first listed.
NCT03491904 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Arizona, Kentucky.
Frequently Asked Questions
What is clinical trial NCT03491904 about?
NCT03491904 is a clinical study titled "To Assess the Patients' Ability to Self-Administer Fasinumab". 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: * ...
What is the current status of trial NCT03491904?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2019-01-23. Estimated completion is 2020-12-15.
What conditions does trial NCT03491904 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Osteoarthritis, Hip.
What interventions are being tested in trial NCT03491904?
The interventions under investigation include: Fasinumab AI (DRUG), Fasinumab PFS (DRUG).
Who is sponsoring clinical trial NCT03491904?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03491904 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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