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
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
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.
This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab
 osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June
 2010 for potential safety issues.
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.