Clareo Health | Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
