We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip (FACT LTS & OA)

This study is currently recruiting participants.
Verified May 2017 by Regeneron Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT02683239
First Posted: February 17, 2016
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
  Purpose

This study of up to 7,000 participants will further characterize the safety profile of fasinumab.

A subset of approximately 1,000 participants at select sites will also participate in a sub-study to characterize the efficacy of fasinumab.


Condition Intervention Phase
Osteoarthritis of the Knee or Hip Drug: Fasinumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of severe adjudicated arthropathy [ Time Frame: Baseline to week 72 ]
    Primary safety endpoint in main study

  • Change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score [ Time Frame: Baseline to week 16 ]
    Primary efficacy endpoint for sub-study

  • Change from baseline to week 16 in the WOMAC physical function subscale score [ Time Frame: Baseline to week 16 ]
    Co-Primary efficacy endpoint for sub-study


Secondary Outcome Measures:
  • Incidence of adjudicated arthropathy events from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

  • Incidence of adjudicated arthropathy events from baseline to week 72 [ Time Frame: Baseline to week 72 ]
    Secondary safety endpoint

  • Incidence of joint replacements (JRs) from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

  • Incidence of JRs from baseline to week 72 [ Time Frame: Baseline to week 72 ]
    Secondary safety endpoint

  • Change from baseline in minimum joint space width of the index knee from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

  • Change from baseline in minimum joint space width of the index knee from baseline to week 72 [ Time Frame: Baseline to week 72 ]
    Secondary safety endpoint

  • Change from baseline in minimum joint space width of the index hip from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

  • Change from baseline in minimum joint space width of the index hip from baseline to week 72 [ Time Frame: Baseline to week 72 ]
    Secondary safety endpoint

  • Incidence of sympathetic nervous system dysfunction events from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

  • Incidence of sympathetic nervous system dysfunction events from baseline to week 72 [ Time Frame: Baseline to week 72 ]
    Secondary safety endpoint

  • Incidence of confirmed orthostatic hypotension from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

  • Incidence of confirmed orthostatic hypotension from baseline to week 72 [ Time Frame: Baseline to week 72 ]
    Secondary safety endpoint

  • Incidence of adverse events (AEs) from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

  • Incidence of AEs from baseline to week 72 [ Time Frame: Baseline to week 72 ]
    Secondary safety endpoint

  • Incidence of serious adverse events (SAEs) from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

  • Incidence of SAEs from baseline to week 72 [ Time Frame: Baseline to week 72 ]
    Secondary safety endpoint

  • Incidence of adverse events of special interest (AESIs) from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

  • Incidence of AESIs from baseline to week 72 [ Time Frame: Baseline to week 72 ]
    Secondary safety endpoint

  • Change from baseline to week 16 in the Patient Global Assessment for osteoarthritis (OA) score [ Time Frame: Baseline up to week 16 ]
    Secondary efficacy endpoint for sub-study

  • Percentage of participants who had a response at week 16, with response defined as an improvement by ≥30% in WOMAC pain subscale scores [ Time Frame: Baseline up to week 16 ]
    Secondary efficacy endpoint for sub-study


Estimated Enrollment: 7000
Study Start Date: March 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fasinumab dosing regimen 1
Sub-study only
Drug: Fasinumab
Participants will receive sub-cutaneous (SC) injections of fasinumab
Other Name: REGN475
Experimental: Fasinumab dosing regimen 2 Drug: Fasinumab
Participants will receive sub-cutaneous (SC) injections of fasinumab
Other Name: REGN475
Experimental: Fasinumab dosing regimen 3 Drug: Fasinumab
Participants will receive sub-cutaneous (SC) injections of fasinumab
Other Name: REGN475
Experimental: Fasinumab dosing regimen 4 Drug: Fasinumab
Participants will receive sub-cutaneous (SC) injections of fasinumab
Other Name: REGN475
Experimental: Placebo Drug: Placebo
Participants will receive sub-cutaneous (SC) injections of matching placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥18 years of age at the screening visit
  2. Clinical diagnosis of 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
  3. Moderate to severe pain in the index joint defined as a WOMAC average pain subscale score of ≥4
  4. A history of inadequate pain relief or intolerance to analgesics used for OA
  5. History of regular use of analgesic medications for OA pain

Exclusion Criteria:

  1. History or presence at the screening visit of non OA inflammatory joint disease
  2. History or presence on imaging of destructive arthropathy, neuropathic joint arthropathy, hip dislocation or significant bone collapse or loss
  3. Patient is not a candidate for MRI
  4. Is scheduled for a joint replacement surgery to be performed during the study period
  5. Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the screening visit.
  6. History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
  7. Evidence of autonomic neuropathy as defined in the Survey of Autonomic Symptoms
  8. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
  9. Pregnant or breast-feeding women
  10. Women of childbearing potential who have a positive pregnancy test result or do not have their pregnancy test result at baseline
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683239


Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

  Show 107 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02683239     History of Changes
Other Study ID Numbers: R475-PN-1523
First Submitted: January 28, 2016
First Posted: February 17, 2016
Last Update Posted: May 18, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases