Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip
Condition: Osteoarthritis of the Knee or Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Fasinumab; Placebo
Intervention description: Participants will receive sub-cutaneous (SC) injections of fasinumab; Participants will receive sub-cutaneous (SC) injections of matching placebo
Intervention MeSH terms: Fasinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5331.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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