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

Regeneron Pharmaceuticals5,331 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

5,331

Conditions

Osteoarthritis of the Knee or Hip

Interventions

FasinumabDRUG

Participants will receive sub-cutaneous (SC) injections of fasinumab

PlaceboDRUG

Participants will receive sub-cutaneous (SC) injections of matching placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (149)

Outcomes

Primary Outcomes

Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)

Time frame: Baseline up to week 52

Number of Participants With Any Serious TEAE

Time frame: Baseline up to week 52

Number of Participants With Any Adverse Event (AE) up to Week 72

Time frame: Baseline up to week 72

Number of Participants With Any Serious AE up to Week 72

Time frame: Baseline up to week 72

Number of Participants With Adjudicated Arthropathy (AA)

Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.

Time frame: Baseline up to week 52 and week 72

Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria

DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.

Time frame: Baseline up to week 52 and week 72

Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation

Any participant with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an adverse event of special interest (AESI).

Time frame: Baseline up to week 72

Number of Participants With Sympathetic Nervous System (SNS) Dysfunction

Data from ClinicalTrials.gov

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