Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain

Inclusion Criteria:

• Duration of chronic low back pain for ≥3 months, and treatment with agents for lowback pain for ≥3 months.

• Primary location of low back pain must be between the 12th thoracic vertebra and thelower gluteal folds, with or without radiation into the posterior thigh, classified asCategory 1 or 2 according to the classification of the Quebec Task Force in SpinalDisorders.

• Subjects must be experiencing some benefits from their current stable dose regimen oforal NSAID (celecoxib, loxoprofen or meloxicam) treatment as described in theprotocol, be tolerating their NSAID regimen, be taking this medication regularlyduring the 30 day period prior to the Screening visit and must have had someimprovement in low back pain, but still require additional pain relief at Screening.

• Subjects must maintain a stabilized, protocol specified NSAID dose regimen for atleast the final 2 or 3 weeks of the Screening period.

• Low Back Pain Intensity (LBPI) score of ≥5 at Screening.

• Subjects must be willing to discontinue all pain medications for chronic low back painexcept rescue medication and investigational product and not use prohibited painmedications throughout the duration of the study.

• Female subjects of childbearing potential and at risk for pregnancy must agree tocomply with protocol specified contraceptive requirements.

Exclusion Criteria:

• Subjects exceeding protocol defined BMI limits.

• Diagnosis of osteoarthritis of the knee or hip as defined by the ACR combined clinicaland radiographic criteria.

• Subjects who have Kellgren Lawrence Grade > or =2 radiographic evidence of hip orGrade > or =3 radiographic evidence of knee osteoarthritis will be excluded.

• Subjects who have Kellgren Lawrence Grade < or =2 radiographic evidence of kneeosteoarthritis but who do not meet ACR criteria and do not have pain associatedwith their knee osteoarthritis will be allowed.

• Subjects with symptoms and radiologic findings consistent with osteoarthritis in theshoulder.

• History of lumbosacral radiculopathy within the past 2 years, history of spinalstenosis associated with neurological impairment, or history of neurogenicclaudication.

• Back pain due to recent major trauma within 6 months prior to Screening.

• Surgical intervention during the past 6 months for the treatment of low back pain.

• Planned surgical procedure during the duration of the study.

• History or radiographic evidence of other diseases that could confound efficacy orsafety assessments (eg, rheumatoid arthritis).

• History or radiographic evidence of orthopedic conditions that may increase the riskof, or confound assessment of joint safety conditions during the study.

• History of osteonecrosis or osteoporotic fracture.

• History of significant trauma or surgery to a knee, hip, or shoulder within theprevious year.

• Signs or symptoms of carpal tunnel syndrome in the one year prior to Screening.

• Considered unfit for surgery based upon American Society of Anesthesiologists physicalclassification system for surgery grading, or subjects who would not be willing toundergo joint replacement surgery if required.

• History of intolerance or hypersensitivity to celecoxib/acetaminophen or any of itsexcipients or existence of a medical condition or use of concomitant medication forwhich the use of celecoxib/acetaminophen is contraindicated.

• Use of prohibited medications or prohibited non-pharmacological treatments without theappropriate washout period (if applicable) prior to Screening or IPAP.

• History of known alcohol, analgesic or narcotic abuse within 2 years of Screening.

• Presence of drugs of abuse or illegal drugs in the urine toxicology screen obtained atScreening.

• History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonalantibody or IgG-fusion protein.

• Signs and symptoms of clinically significant cardiac disease.

• Poorly controlled hypertension as defined in the protocol or taking anantihypertensive that has not been stable for at least 1 month prior to Screening.

• Evidence of protocol defined orthostatic hypotension at Screening.

• Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening.

• Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosisof stroke with residual deficits that would preclude completion of required studyactivities.

• History of cancer within 5 years prior to Screening, except for cutaneous basal cellor squamous cell cancer resolved by excision.

• Expected to undergo a therapeutic procedure or to use any analgesic other than thosespecified in the protocol throughout the pre-treatment and treatment periods that islikely to confound assessment of analgesic efficacy or safety.

• Previous exposure to exogenous NGF or to an anti-NGF antibody.

• Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol definedlimits.

• Positive Hepatitis B, Hepatitis C, or HIV tests at screening indicative of currentinfection.

• History, diagnosis, or signs and symptoms of clinically significant neurologicaldisease or clinically significant psychiatric disorder.

• Pregnant, breastfeeding or female subjects of childbearing potential who are unwillingor unable to follow protocol required contraceptive requirements.

• Participation in other investigational drug studies within protocol defined timelimits.

• Other severe acute or chronic medical or psychiatric condition or laboratoryabnormality that in the judgment of the investigator, would make the subjectinappropriate for entry into this study.