Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: tanezumab; diclofenac; tanezumab; diclofenac; tanezumab; diclofenac; diclofenac; IV placebo
Intervention description: IV tanezumab 10 mg every 8 weeks (through Week 16); Oral diclofenac SR 75 mg BID for 32 weeks; IV tanezumab 5 mg every 8 weeks (through Week 16); Oral diclofenac SR 75 mg BID for 32 weeks; IV tanezumab 2.5 mg every 8 weeks (through Week 16); Oral diclofenac SR 75 mg BID for 32 weeks; Oral diclofenac SR 75 mg BID for 32 weeks; IV placebo to match tanezumab every 8 weeks (through Week 16)
Intervention MeSH terms: Diclofenac; 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: 607.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arthritis monoclonal antibody nerve growth factor (NGF) anti-NGF tanezumab PF-04383119 RN-624 OA

Summary:

      The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab
      added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently
      experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day 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 diclofenac 150 mg/day and be tolerating their diclofenac regimen.

          -  Pain and function levels as required by the protocol at Screening and Baseline.

          -  Willing to discontinue all non-study pain medications throughout 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.

          -  History of other disease that may involve index knee or hip including inflammatory
             joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic
             joint diseases, lupus erythematosus, rheumatoid arthritis (RA), joint infections,
             neuropathic disorders, avascular necrosis, Paget's disease or tumors.

          -  Fibromyalgia, regional pain caused by lumbar or cervical compression with
             radiculopathy or other moderate to severe pain that may confound assessments or
             self-evaluation of the pain associated with OA.

          -  Signs and symptoms of clinically significant cardiac disease within 6 months prior to
             screening.

          -  Diagnosis or 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 150
             micro-mol/L in men or 133 micro-mol/L in women.

          -  Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy
             within 30 days prior to Screening.

          -  Known hypersensitivity to NSAIDs (eg, diclofenac), cyclooxygenase inhibitors or
             paracetamol (acetaminophen).