Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.
NCT02709486
ABOUT THIS 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.
- 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
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 | Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee. | ||||||
Official Title ICMJE | A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE | ||||||
Brief Summary | Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important breakthrough in the treatment of chronic pain and is under clinical investigation for the treatment of pain associated with osteoarthritis or other chronic pain conditions. The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy benefits with a favorable safety profile when administered intravenously in previous Phase 3 clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg dose based on data from previous studies. | ||||||
Detailed Description | This is a randomized, double blind, placebo controlled, parallel group multicenter Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for 24 weeks compared to placebo in subjects with osteoarthritis of the knee or hip. A total of approximately 810 subjects will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (ie, 270/group). The randomization will be stratified by index joint (hip or knee), and most severe Kellgren-Lawrence grade (of any knee or hip joint) at study entry (grade 2, 3 or 4). Subjects will receive up to three SC doses of one of the following treatments at an 8-week interval between each injection:
Week 24 is the landmark analysis in this study. Subjects who do not complete the Double-blind Treatment period will enter and complete the 24-week Early-termination follow-up period. | ||||||
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 * | Berenbaum F, Blanco FJ, Guermazi A, Miki K, Yamabe T, Viktrup L, Junor R, Carey W, Brown MT, West CR, Verburg KM. Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period. Ann Rheum Dis. 2020 Jun;79(6):800-810. doi: 10.1136/annrheumdis-2019-216296. Epub 2020 Mar 31. | ||||||
* 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 | 849 | ||||||
Original Estimated Enrollment ICMJE | 810 | ||||||
Actual Study Completion Date ICMJE | November 14, 2018 | ||||||
Actual Primary Completion Date | June 8, 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 | Austria, Bulgaria, Finland, France, Germany, Hungary, Italy, Japan, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02709486 | ||||||
Other Study ID Numbers ICMJE | A4091057 2013-004508-21 ( EudraCT Number ) OA 6-MONTH EU 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 | Eli Lilly and Company | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | June 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |