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



Status:Suspended
Conditions:Arthritis, Arthritis, Chronic Pain, Chronic Pain, Osteoarthritis (OA)
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:11/24/2017
Start Date:July 21, 2015
End Date:February 26, 2019

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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

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.


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
We found this trial at
291
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Anaheim, California 92805
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
386-760-3862
About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...
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3801 N. Fairfax Drive
Arlington, Virginia 22203
703-527-8100
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430 Morton Plant St # 301
Clearwater, Florida 33756
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4110 Center Point Dr.
Fort Myers, Florida 33916
239-936-4421
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736 E Bullard Ave
Fresno, California 93710
559-437-9700
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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8420 S. Eastern Ave.
Las Vegas, Nevada 89123
702-898-2088
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400 Tower Rd Ne
Marietta, Georgia 30060
678-581-5252
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8200 SW 117th Ave # 210
Miami, Florida 33183
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
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3212 Cove Bend Drive
Tampa, Florida 33613
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Albuquerque, New Mexico 87108
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Altoona, Pennsylvania 16602
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Anaheim, California 92801
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Atlantis, Florida 33462
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Augusta, Georgia 30909
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Austin, Texas 78745
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11714 Wilson Parke Avenue
Austin, Texas 78726
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Aventura, Florida 33180
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Baton Rouge, Louisiana 70806
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Bay City, Michigan 48706
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Baytown, Texas 77521
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Bellevue, Washington 98007
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Birmingham, Alabama 35235
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Boca Raton, Florida 33486
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Broadmeadow, New South Wales 2292
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Brooklyn, New York 11235
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Cerritos, California 90703
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Charlottesville, Virginia 22911
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Chicago, Illinois 60603
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Chicago, Illinois 60640
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Cincinnati, Ohio 45224
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Cincinnati, Ohio 45242
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Cincinnati, Ohio 45227
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Clearwater, Florida 33761
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Columbia, Missouri 65203
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Columbus, Ohio 43215
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430 West Badillo Street
Covina, California 91723
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Cumberland, Maryland 21502
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Danbury, Connecticut 06810
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El Cajon, California 92020
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1955 Citracado Parkway
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Evansville, Indiana 47714
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Fort Lauderdale, Florida 33306
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IMA
Fort Myers, Florida 33912
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Frederick, Maryland 21702
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