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

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ClinicalTrials.gov Identifier: NCT02683239
Recruitment Status : Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

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 or disease Intervention/treatment Phase
Osteoarthritis of the Knee or Hip Drug: Fasinumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3565 participants
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
Actual Study Start Date : March 28, 2016
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : January 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Incidence of severe destructive arthropathy (DA) [ Time Frame: Baseline to week 72 ]
    Primary safety endpoint in main study

  2. 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

  3. 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 :
  1. Incidence of adjudicated arthropathy (AA) events from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

  2. Incidence of AA events from baseline to week 72 [ Time Frame: Baseline to week 72 ]
    Secondary safety endpoint

  3. Incidence of DA events from baseline to week 52 [ Time Frame: Baseline to week 52 ]
  4. Incidence of joint replacements (JRs) from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

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

  6. Incidence of peripheral neurosensory AEs from baseline to week 52 [ Time Frame: Baseline to week 52 ]
    Secondary safety endpoint

  7. Incidence of peripheral neurosensory AEs from baseline to week 72 [ Time Frame: Baseline to week 72 ]
    Secondary safety endpoint

  8. 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

  9. 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

  10. 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

  11. 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

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

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

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

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

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

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

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

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

  20. Incidence of JRs at the telephone survey approximately 52 weeks after the last does of study drug [ Time Frame: Week 100 ]
    Secondary safety endpoint

  21. 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

  22. 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



Information from the National Library of Medicine

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

Key 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 12 weeks of analgesic use for OA of the knee or hip
  5. History of regular use of analgesic medications for OA pain

Key Exclusion Criteria:

  1. History or presence at the screening visit of non OA inflammatory joint disease
  2. History or presence on imaging of arthropathy, stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation, knee dislocation, congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation or collapse, or primary metastatic tumor with the exception of chondromas or pathologic fracture during the screening period
  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. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
  8. Pregnant or breast-feeding women
  9. Women of childbearing potential who have a positive pregnancy test result or do not have their pregnancy test result at baseline

Note: Other protocol defined Inclusion/Exclusion criteria may apply


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


  Show 108 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02683239     History of Changes
Other Study ID Numbers: R475-PN-1523
2015-003783-36 ( EudraCT Number )
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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