Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee

NCT02528188

Last updated date
Study Location
Central Alabama Research
Birmingham, Alabama, 35209, United States
Contact
877-355-1995

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Pain, Hip Osteoarthritis, Knee Osteoarthritis
Sex
Females and Males
Age
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.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Tablets
Subcutaneous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes addition
Trial Procedures
Blood test
Urine test
Physical examination
Vital signs and measurements
Keeping a diary
Electrocardiogram (ECG)
Questionnaire
X-rays

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Chronic Pain, Hip Osteoarthritis, Knee OsteoarthritisLong Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee NCT02528188
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Chronic Pain
  • Osteoarthritis, Hip
  • Osteoarthritis, Knee
Intervention  ICMJE
  • Drug: NSAID
    Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
  • Biological: Tanezumab 2.5 mg
    Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks
  • Biological: Tanezumab 5 mg
    Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks
Study Arms  ICMJE
  • Active Comparator: NSAID
    Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
    Intervention: Drug: NSAID
  • Experimental: Tanezumab 2.5 mg
    Subcutaneous injection of tanezumab 2.5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac ER) twice daily for 56 weeks
    Intervention: Biological: Tanezumab 2.5 mg
  • Experimental: Tanezumab 5 mg
    Subcutaneous injection of tanezumab 5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac) twice daily for 56 weeks
    Intervention: Biological: Tanezumab 5 mg
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
 (submitted: February 20, 2019)
3021
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2015)
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:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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