Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
Condition: Osteoarthritis; Arthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: NSAID; tanezumab; tanezumab; tanezumab; NSAID; tanezumab; NSAID
Intervention description: IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks; IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56; IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56; IV tanezumab 5 mg every 8 weeks (through Week 48); Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks; IV tanezumab 10 mg every 8 weeks (through Week 48); Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
Intervention MeSH terms: Anti-Inflammatory Agents, Non-Steroidal; Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2720.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: monoclonal antibody; nerve growth factor (NGF); anti-NGF; tanezumab; PF-04383119; RN624; osteoarthritis (OA)

Summary:

      The purpose of this study is to investigate the long-term analgesic efficacy and safety of
      tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing
      partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID)
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence
             x-ray grade equal to, or greater than, 2.

          -  Patients must be experiencing some benefit from their current stable dose regimen of
             oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either
             100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.

          -  Pain level and function levels as required by the protocol at Screening and Baseline.

          -  Willing to discontinue all non-study pain medications for osteoarthritis except rescue
             medication (acetaminophen) and not use prohibited pain medications throughout the
             duration of the study except as permitted per protocol.

          -  Willing and able to comply with lifestyle guidelines, scheduled visits, treatment
             plan, laboratory tests and other study procedures.

        Exclusion Criteria:

          -  Pregnant women.

          -  BMI greater than 39.

          -  Fibromyalgia, regional pain caused by lumbar or cervical compression with
             radiculopathy or other moderate to sever pain that may confound assessments or
             self-evaluation of the pain associated with OA.

          -  Signs and symptoms of clinically significant cardiac disease with 6 months prior to
             screening.

          -  Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with
             residual deficits that would preclude completion of required study activities.

          -  History, diagnosis, signs or symptoms of clinically significant neurological and/or
             psychiatric disease/disorder.

          -  At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%,
             ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7
             mg/dL (men) or 1.5 mg/dL (women).

          -  Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy
             within 30 days prior to screening.

          -  Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.