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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of the Knee or Hip

Treatments: Drug: Placebo; Drug: Fasinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02683239

R475-PN-1523

2015-003783-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 5,331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5,331 participants in 3 patient groups

Fasinumab dosing regimen 1

Experimental group

Treatment:

Drug: Fasinumab

Fasinumab dosing regimen 2

Experimental group

Treatment:

Drug: Fasinumab

Placebo

Experimental group

Treatment:

Drug: Placebo