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Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.

Last updated on June 11, 2019

Study Location
Nuhr Medical Center
Senftenberg, , 3541 Austria
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Hip Osteoarthritis, Knee Osteoarthritis
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- A diagnosis of osteoarthritis of the index hip or knee based on American College of
Rheumatology criteria with Kellgren Lawrence x-ray Grade of at least 2 as diagnosed by
the Central Reader

- A history of insufficient pain relief from acetaminophen along with a history of
insufficient pain relief from, inability to tolerate or contraindication to taking
NSAIDs, and tramadol or opioid treatments.

- WOMAC Pain subscale score of at least 5 in the index hip or knee at Screening.

- Be willing to discontinue all non study pain medications for osteoarthritis and not
use prohibited pain medications throughout the duration of the study.

- Female subjects of childbearing potential must agree to comply with protocol specified
contraceptive requirements.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects exceeding protocol defined BMI or body weight limits.

- History of other diseases specified in the protocol (e.g. inflammatory joint diseases,
crystalline diseases such as gout or pseudogout) that may involve the index joint and
that could interfere with efficacy assessments.

- Radiographic evidence of protocol specified bone or joint conditions in any screening
radiograph as determined by the central radiology reviewer.

- A history of osteonecrosis or osteoporotic fracture.

- History of significant trauma or surgery to a knee, hip or shoulder within the
previous year.

- Planned surgical procedure during the duration of the study.

- Presence of conditions (e.g. fibromyalgia, radiculopathy) associated with moderate to
severe pain that may confound assessments or self evaluation of osteoarthritis pain.

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

- Considered unfit for surgery based upon American Society of Anesthesiologists physical
classification system for surgery grading, or subjects who would not be willing to
undergo joint replacement surgery if required.

- History of intolerance or hypersensitivity to acetaminophen or any of its excipients
or existence of a medical condition or use of concomitant medication for which the use
of acetaminophen is contraindicated.

- Use of prohibited medications without the appropriate washout period prior to
Screening or Initial Pain Assessment Period.

- History of cancer within 5 years of Screening, except for cutaneous basal cell or
squamous cell cancer resolved by excision.

- Subjects with signs and symptoms of clinically significant cardiac disease as
described in the protocol.

- Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis
of stroke with residual deficits that would preclude completion of required study

- History, diagnosis, or signs and symptoms of clinically significant neurological
disease such as but not limited to peripheral or autonomic neuropathy.

- History, diagnosis, signs or symptoms of any clinically significant psychiatric

- History of known alcohol, analgesic or drug abuse within 2 years of Screening.

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

- History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal
antibody or IgG fusion protein.

- Poorly controlled hypertension as defined in the protocol or taking an
antihypertensive 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.

- Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined

- Presence of drugs of abuse in screening urine toxicology panel.

- Positive hepatitis B, hepatitis C or HIV test results indicative of current infection.

- Participation in other investigational drug studies within protocol defined time

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

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.


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