Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee

• Osteoarthritis, Knee
• Osteoarthritis, Hip

• Other: Placebo
  
  Patient receives one dose of placebo to match tanezumab subcutaneously on Day 1 and one dose of placebo to match tanezumab subcutaneously at Week 8.
• Biological: Tanezumab 2.5 mg
  
  Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 2.5 mg subcutaneously at Week 8.
• Biological: Tanezumab 2.5mg/5mg
  
  Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 5 mg subcutaneously at Week 8.
  Other Name: Titration Arm

• Placebo Comparator: Placebo
  
  placebo administered subcutaneously at day 0 and week 8
  Intervention: Other: Placebo
• Experimental: Tanezumab 2.5 mg
  
  tanezumab 2.5 mg administered subcutaneously at day 0 and week 8
  Intervention: Biological: Tanezumab 2.5 mg
• Experimental: Tanezumab 2.5mg/5mg
  
  tanezumab 2.5 mg administered subcutaneously at day 0 and tanezumab 5 mg administered subcutaneously at week 8
  Intervention: Biological: Tanezumab 2.5mg/5mg

Inclusion Criteria:

• Diagnosis of Osteoarthritis of the knee or hip confirmed by X-ray
• Documented history that subject tried the following medications and had insufficient pain relief or is cannot take or tolerate them: acetaminophen, NSAIDs and either tramadol or opioids
• Meet the protocol requirements for pain at screening and pain, physical function and patient global assessment of osteoarthritis at baseline
• Willing to discontinue all pain medications except study medication and rescue medication during the course of the study and use those as directed per protocol
• Women able to have children must agree to use 2 forms of contraception during the study

Exclusion Criteria:

• Body Mass Index (BMI) greater than 39
• History of diseases other than osteoarthritis in a shoulder, hip or knee (example, rheumatoid arthritis, gout, joint infections, osteonecrosis)
• Patients with x-ray showing joint conditions such as osteonecrosis (dead bone) or certain types of fractures
• Patients who have had significant trauma or surgery to a knee, hip or shoulder within the previous year
• Planned surgical procedure during the study
• Patients who are largely or wholly incapacitated (example bedridden or confined to a wheelchair, permitting little or no self-care)
• Patients who would be unwilling or unable to undergo joint replacement surgery if one eventually became necessary
• Patients with significant conditions other than osteoarthritis that could interfere with assessment of pain in the joints (example fibromyalgia, lupus erythematosus)
• Patients with significant heart, neurological or psychiatric diseases
• Patients who had cancer other than certain skin cancers within the past 5 years
• Patients with alcohol, analgesic (pain medications) or drug abuse within the past 2 years
• Women who are pregnant, breast-feeding or intending to become pregnant or breast-feed during the course of the study.