Back to resultsTo Assess the Patients' Ability to Self-Administer Fasinumab (FACT DEVICE)
Primary Purpose
Osteoarthritis, Knee, Osteoarthritis, Hip
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fasinumab AI
Fasinumab PFS
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Key Inclusion Criteria:
- A clinical diagnosis of Osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit
- Moderate-to-severe pain in the index joint defined as a WOMAC average pain subscale score of ≥4 at both the screening and randomization visits
- Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments
- A history of at least 12 weeks of analgesic use for pain due to OA of the knee or hip
- History of regular use of analgesic medications for OA pain (defined as an average of 4 days per week over the 4 weeks prior to the screening visit), including NSAIDs, selective cyclooxygenase 2 inhibitors, opioids, paracetamol/acetaminophen, or combinations thereof
Key Exclusion Criteria:
- History or presence at the screening visit of non-OA inflammatory joint disease (eg,rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout, spondyloarthropathy, polymyalgia rheumatica, joint infections within the past 5 years), Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
- History or presence on imaging of arthropathy (osteonecrosis, subchondral insufficiency fracture, rapidly progressive OA type 1 or type 2), stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation (prosthetic hip dislocation is eligible), knee dislocation (patella dislocation is eligible), congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation of collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures during the screening period
- Trauma to the index joint within 3 months prior to the screening visit
- Signs or symptoms of carpal tunnel syndrome within 6 months of screening
- Patient is not a candidate for MRI
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Sites / Locations
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
- Regeneron Research Facility
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Auto-injector (AI)
Prefilled syringe (PFS)
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Proportion of successful fasinumab injections administered by patients or their caregivers using an AI in an unsupervised setting (per patient report)
Number of AI associated product technical complaint (PTCs)
Number of validated AI associated PTFs
Number of patients with an AI associated PTC
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
Patient satisfaction with the AI as assessed using the Self-Injection Assessment Questionnaire (SIAQ)
Number of participants who experience Adjudicated arthropathy (AA)
As confirmed by independent adjudication
Number of participants who experience Destructive arthropathy (DA)
As confirmed by independent adjudication
Number of participants who experience treatment-emergent adverse events (TEAEs)
Number of participants who experience sympathetic nervous system dysfunction
Number of participants who experience peripheral sensory adverse events (AEs) that require a neurology or other specialty consultation
Number of participants who experience all-cause Joint replacement (JR)s
Number of participants who experienced JR at the telephone survey
Maximum observed drug concentration (Cmax)
Area under the curve from the time of dosing to the end of dosing interval (AUC)
Geometric mean ratio of Cmax and AUC for the AI device (CI) of the geometric mean ratio
Geometric mean ratio of Cmax and AUC for the PFS device (CI) of the geometric mean ratio
Incidence of anti-drug antibody (ADA)
Full Information
NCT ID
NCT03491904
First Posted
April 2, 2018
Last Updated
March 2, 2021
Sponsor
Regeneron Pharmaceuticals
Collaborators
Teva Pharmaceutical Industries, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03491904
Brief Title
To Assess the Patients' Ability to Self-Administer Fasinumab
Acronym
FACT DEVICE
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Teva Pharmaceutical Industries, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Osteoarthritis, Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auto-injector (AI)
Arm Type
Experimental
Arm Title
Prefilled syringe (PFS)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fasinumab AI
Other Intervention Name(s)
REGN475
Intervention Description
Self-administered with auto injector
Intervention Type
Drug
Intervention Name(s)
Fasinumab PFS
Other Intervention Name(s)
REGN475
Intervention Description
Prefilled syringe administered by study staff
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Number of AI associated product technical complaint (PTCs)
Time Frame
Baseline to Week 16
Title
Number of validated AI associated PTFs
Time Frame
Baseline to Week 16
Title
Number of patients with an AI associated PTC
Time Frame
Baseline to Week 16
Title
Number of AI use-related errors
Description
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
Title
Patient satisfaction with the AI as assessed using the Self-Injection Assessment Questionnaire (SIAQ)
Time Frame
Baseline to Week 16
Title
Number of participants who experience Adjudicated arthropathy (AA)
Description
As confirmed by independent adjudication
Time Frame
Through week 36
Title
Number of participants who experience Destructive arthropathy (DA)
Description
As confirmed by independent adjudication
Time Frame
Through week 36
Title
Number of participants who experience treatment-emergent adverse events (TEAEs)
Time Frame
Through week 16
Title
Number of participants who experience sympathetic nervous system dysfunction
Time Frame
Through week 36
Title
Number of participants who experience peripheral sensory adverse events (AEs) that require a neurology or other specialty consultation
Time Frame
Through week 36
Title
Number of participants who experience all-cause Joint replacement (JR)s
Time Frame
Through week 36
Title
Number of participants who experienced JR at the telephone survey
Time Frame
52 weeks after last dose of study drug
Title
Maximum observed drug concentration (Cmax)
Time Frame
Up to 36 weeks
Title
Area under the curve from the time of dosing to the end of dosing interval (AUC)
Time Frame
Up to 36 weeks
Title
Geometric mean ratio of Cmax and AUC for the AI device (CI) of the geometric mean ratio
Time Frame
Up to 36 weeks
Title
Geometric mean ratio of Cmax and AUC for the PFS device (CI) of the geometric mean ratio
Time Frame
Up to 36 weeks
Title
Incidence of anti-drug antibody (ADA)
Time Frame
Up to 36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
A clinical diagnosis of Osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit
Moderate-to-severe pain in the index joint defined as a WOMAC average pain subscale score of ≥4 at both the screening and randomization visits
Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments
A history of at least 12 weeks of analgesic use for pain due to OA of the knee or hip
History of regular use of analgesic medications for OA pain (defined as an average of 4 days per week over the 4 weeks prior to the screening visit), including NSAIDs, selective cyclooxygenase 2 inhibitors, opioids, paracetamol/acetaminophen, or combinations thereof
Key Exclusion Criteria:
History or presence at the screening visit of non-OA inflammatory joint disease (eg,rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout, spondyloarthropathy, polymyalgia rheumatica, joint infections within the past 5 years), Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
History or presence on imaging of arthropathy (osteonecrosis, subchondral insufficiency fracture, rapidly progressive OA type 1 or type 2), stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation (prosthetic hip dislocation is eligible), knee dislocation (patella dislocation is eligible), congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation of collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures during the screening period
Trauma to the index joint within 3 months prior to the screening visit
Signs or symptoms of carpal tunnel syndrome within 6 months of screening
Patient is not a candidate for MRI
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Research Facility
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Regeneron Research Facility
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85307
Country
United States
Facility Name
Regeneron Research Facility
City
Los Angeles
State/Province
California
ZIP/Postal Code
90029
Country
United States
Facility Name
Regeneron Research Facility
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Regeneron Research Facility
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Regeneron Research Facility
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Facility Name
Regeneron Research Facility
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Regeneron Research Facility
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Regeneron Research Facility
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Regeneron Research Facility
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Regeneron Research Facility
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Regeneron Research Facility
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Regeneron Research Facility
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Regeneron Research Facility
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Regeneron Research Facility
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Regeneron Research Facility
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Regeneron Research Facility
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73114
Country
United States
Facility Name
Regeneron Research Facility
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Regeneron Research Facility
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
Regeneron Research Facility
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Regeneron Research Facility
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Regeneron Research Facility
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Regeneron Research Facility
City
Houston
State/Province
Texas
ZIP/Postal Code
77804
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing Time Frame
Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
IPD Sharing URL
https://vivli.org/
Learn more about this trial
To Assess the Patients' Ability to Self-Administer Fasinumab
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