Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
NCT02528188
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
877-355-1995
- A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the Central Reader
- Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib, diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or ketoprofen) as described in the protocol along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking acetaminophen and, tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period
- WOMAC Pain subscale score of at least 5 in the index knee or hip 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
- Subjects exceeding protocol defined BMI or body weight limits
- History of other diseases specified in the protocol (eg, 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 (eg, fibromyaliga, 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
- Contraindications to magnetic resonance imaging
- History of intolerance or hypersensitivity to the oral NSAID (naproxen, celecoxib or
diclofenac) the subject could be randomized to receive or any of its excipients or
existence of a medical condition or use of concomitant medication for which the use of
this NSAID is contraindicated
- 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
activities
- 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
disorder
- 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
limits
- 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
limits
- 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
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Descriptive Information | |||||||
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Brief Title ICMJE | Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee | ||||||
Official Title ICMJE | A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE | ||||||
Brief Summary | The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | ||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 3021 | ||||||
Original Estimated Enrollment ICMJE | 3000 | ||||||
Actual Study Completion Date ICMJE | February 27, 2019 | ||||||
Actual Primary Completion Date | October 5, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Brazil, Bulgaria, Colombia, Croatia, Japan, Korea, Republic of, Lithuania, Mexico, New Zealand, Peru, Philippines, Russian Federation, Serbia, Slovakia, Taiwan, Ukraine, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02528188 | ||||||
Other Study ID Numbers ICMJE | A4091058 2012-003721-22 ( EudraCT Number ) OA SAFETY STUDY ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |