To Assess the Patients' Ability to Self-Administer Fasinumab

Osteoarthritis, Knee Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491904
• Other study ID #: R475-PN-1602
• Status: Completed
• Phase: Phase 1
• Start date: January 23, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: March 2021
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. 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

2. 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

3. Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments

4. A history of at least 12 weeks of analgesic use for pain due to OA of the knee or hip

5. 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:

1. 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

2. 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

3. Trauma to the index joint within 3 months prior to the screening visit

4. Signs or symptoms of carpal tunnel syndrome within 6 months of screening

5. Patient is not a candidate for MRI

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Drug:
• Fasinumab AI
Self-administered with auto injector
• Fasinumab PFS
Prefilled syringe administered by study staff

Locations

Country	Name	City	State
United States	Regeneron Research Facility	Atlanta	Georgia
United States	Regeneron Research Facility	Bristol	Tennessee
United States	Regeneron Research Facility	Dallas	Texas
United States	Regeneron Research Facility	Gilbert	Arizona
United States	Regeneron Research Facility	Glendale	Arizona
United States	Regeneron Research Facility	Houston	Texas
United States	Regeneron Research Facility	Houston	Texas
United States	Regeneron Research Facility	Houston	Texas
United States	Regeneron Research Facility	Jamaica	New York
United States	Regeneron Research Facility	Knoxville	Tennessee
United States	Regeneron Research Facility	Lexington	Kentucky
United States	Regeneron Research Facility	Lexington	Kentucky
United States	Regeneron Research Facility	Los Angeles	California
United States	Regeneron Research Facility	Ocala	Florida
United States	Regeneron Research Facility	Oklahoma City	Oklahoma
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	Statesville	North Carolina
United States	Regeneron Research Facility	West Des Moines	Iowa
United States	Regeneron Research Facility	Wheat Ridge	Colorado
United States	Regeneron Research Facility	Wichita	Kansas
United States	Regeneron Research Facility	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Teva Pharmaceutical Industries, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline to Week 16
Secondary	Proportion of successful fasinumab injections administered by patients or their caregivers using an AI in an unsupervised setting (per patient report)		Baseline to Week 16
Secondary	Number of AI associated product technical complaint (PTCs)		Baseline to Week 16
Secondary	Number of validated AI associated PTFs		Baseline to Week 16
Secondary	Number of patients with an AI associated PTC		Baseline to Week 16
Secondary	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	Baseline to Week 16
Secondary	Patient satisfaction with the AI as assessed using the Self-Injection Assessment Questionnaire (SIAQ)		Baseline to Week 16
Secondary	Number of participants who experience Adjudicated arthropathy (AA)	As confirmed by independent adjudication	Through week 36
Secondary	Number of participants who experience Destructive arthropathy (DA)	As confirmed by independent adjudication	Through week 36
Secondary	Number of participants who experience treatment-emergent adverse events (TEAEs)		Through week 16
Secondary	Number of participants who experience sympathetic nervous system dysfunction		Through week 36
Secondary	Number of participants who experience peripheral sensory adverse events (AEs) that require a neurology or other specialty consultation		Through week 36
Secondary	Number of participants who experience all-cause Joint replacement (JR)s		Through week 36
Secondary	Number of participants who experienced JR at the telephone survey		52 weeks after last dose of study drug
Secondary	Maximum observed drug concentration (Cmax)		Up to 36 weeks
Secondary	Area under the curve from the time of dosing to the end of dosing interval (AUC)		Up to 36 weeks
Secondary	Geometric mean ratio of Cmax and AUC for the AI device (CI) of the geometric mean ratio		Up to 36 weeks
Secondary	Geometric mean ratio of Cmax and AUC for the PFS device (CI) of the geometric mean ratio		Up to 36 weeks
Secondary	Incidence of anti-drug antibody (ADA)		Up to 36 weeks