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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)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683239
Recruitment Status : Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
Teva Pharmaceutical Industries, Ltd.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5331 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 : February 17, 2016
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : June 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Fasinumab dosing regimen 1 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: Placebo Drug: Placebo
Participants will receive sub-cutaneous (SC) injections of matching placebo




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Baseline to week 52 ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Baseline to week 52 ]
  3. Incidence of adverse events of special interest (AESI) [ Time Frame: Baseline to week 52 ]
  4. Incidence of laboratory abnormalities [ Time Frame: Baseline to week 52 ]
  5. Incidence of anti-fasinumab antibody formation [ Time Frame: Baseline to week 52 ]
  6. Incidence of adverse events (AEs) [ Time Frame: Baseline to week 72 ]
  7. Incidence of serious adverse events (SAEs) [ Time Frame: Baseline to week 72 ]
  8. Incidence of adverse events of special interest (AESI) [ Time Frame: Baseline to week 72 ]
  9. Incidence of laboratory abnormalities [ Time Frame: Baseline to week 72 ]
  10. Incidence of anti-fasinumab antibody formation [ Time Frame: Baseline to week 72 ]


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 Western Ontario and McMaster Universities Osteoarthritis Index (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. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
  4. Patient is not a candidate for MRI
  5. Is scheduled for a joint replacement surgery to be performed during the study period
  6. Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the screening visit.
  7. History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
  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

Note: Other protocol defined Inclusion/Exclusion criteria 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


Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Teva Pharmaceutical Industries, Ltd.
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02683239    
Other Study ID Numbers: R475-PN-1523
2015-003783-36 ( EudraCT Number )
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Fasinumab
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs