Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee
Condition: Osteoarthritis, Knee; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Intervention: Placebo; Tanezumab 2.5 mg; Tanezumab 2.5mg/5mg
Intervention description: 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.; 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.; Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 5 mg subcutaneously at Week 8.
Intervention MeSH terms: 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: 698.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: osteoarthritis of the knee; osteoarthritis of the hip; nerve growth factor inhibitor; tanezumab

Summary:

      The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab
      in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg)
      at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study
      also evaluates the safety of the treatment regimens.
    

Eligibility criteria:

        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.