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OpenTrials
Completed

NCT Number: NCT03491904

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:

* 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Regeneron Research Facility, Gilbert, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fasinumab AI

Drug

Self-administered with auto injector

Other names: REGN475

Fasinumab PFS

Drug

Prefilled syringe administered by study staff

Other names: REGN475

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Number of AI associated product technical complaint (PTCs)

    Time frame: Baseline to Week 16

  3. Number of validated AI associated PTFs

    Time frame: Baseline to Week 16

  4. Number of patients with an AI associated PTC

    Time frame: Baseline to Week 16

  5. Number of AI use-related errors

    Time frame: Baseline to Week 16

    Including but not limited to improper storage, inappropriate use of the device, dosing schedule mistakes, and user handling mistakes

  6. Patient satisfaction with the AI as assessed using the Self-Injection Assessment Questionnaire (SIAQ)

    Time frame: Baseline to Week 16

  7. Number of participants who experience Adjudicated arthropathy (AA)

    Time frame: Through week 36

    As confirmed by independent adjudication

  8. Number of participants who experience Destructive arthropathy (DA)

    Time frame: Through week 36

    As confirmed by independent adjudication

  9. Number of participants who experience treatment-emergent adverse events (TEAEs)

    Time frame: Through week 16

  10. Number of participants who experience sympathetic nervous system dysfunction

    Time frame: Through week 36

  11. Number of participants who experience peripheral sensory adverse events (AEs) that require a neurology or other specialty consultation

    Time frame: Through week 36

  12. Number of participants who experience all-cause Joint replacement (JR)s

    Time frame: Through week 36

  13. Number of participants who experienced JR at the telephone survey

    Time frame: 52 weeks after last dose of study drug

  14. Maximum observed drug concentration (Cmax)

    Time frame: Up to 36 weeks

  15. Area under the curve from the time of dosing to the end of dosing interval (AUC)

    Time frame: Up to 36 weeks

  16. Geometric mean ratio of Cmax and AUC for the AI device (CI) of the geometric mean ratio

    Time frame: Up to 36 weeks

  17. Geometric mean ratio of Cmax and AUC for the PFS device (CI) of the geometric mean ratio

    Time frame: Up to 36 weeks

  18. Incidence of anti-drug antibody (ADA)

    Time frame: Up to 36 weeks

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Teva Pharmaceutical Industries, Ltd.

Registry information

Official study 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

Acronym: FACT DEVICE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2018
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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