Phase
Condition
Osteoarthritis
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria (additional criteria may apply at screening):
A clinical diagnosis of osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit.
Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (acetaminophen/paracetamol to be taken as needed with a maximum daily dose of 2500 mg [countries where 500 mg strength tablets/capsules are available] or 2600 mg [countries where 325 mg strength tablets/capsules are available])
A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics used for pain due to OA of the knee or hip
Currently using a stable dose of NSAID
Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the 24 weeks of treatment
Key Exclusion Criteria (additional criteria may apply at screening):
Non-compliance with the numeric rating scale (NRS) recording during the pre-randomization period
History or presence at the screening visit of non-OA inflammatory joint disease, Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
History or presence on imaging of arthropathy, hip or knee dislocation, extensive subchondral cysts, evidence of severe structural damage, bone collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures
Trauma to the index joint within 3 months prior to the screening visit
Signs or symptoms of carpal tunnel syndrome within 6 months of screening
Patient is not a candidate for magnetic resonance imaging (MRI)
Is scheduled for a JR surgery to be performed during the study period or who would be unwilling or unable to undergo JR surgery if needed
History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs)
History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
Use of systemic corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit
Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies
Women of childbearing potential who are unwilling to practice highly effective contraception prior to the start of the first treatment, during the study, and for at least 20 weeks after the last dose
Study Design
Connect with a study center
Pinnacle Research Group, Llc
Anniston, Alabama 36207
United StatesSite Not Available
Horizon Research Partners
Mobile, Alabama 36608
United StatesSite Not Available
Clinical Research Advantage, Inc./Warner Family Practice, PC
Chandler, Arizona 85224
United StatesSite Not Available
Synexus Central Phoenix Medical Clinic
Phoenix, Arizona 85020
United StatesSite Not Available
Clinical Research Consortium Arizona
Tempe, Arizona 85283
United StatesSite Not Available
Advance Research Center
Anaheim, California 92805
United StatesSite Not Available
TriWest Research Associates, LLC
El Cajon, California 92020
United StatesSite Not Available
Paragon Rx Clinical Research, Inc.
Garden Grove, California 92840
United StatesSite Not Available
Catalina Research Institute, LLC
Montclair, California 91763
United StatesSite Not Available
Sierra Clinical Research
Roseville, California 95661
United StatesSite Not Available
UC Davis Center for Musculoskeletal Health
Sacramento, California 95817
United StatesSite Not Available
Advanced Research Center, Inc
San Diego, California 92103
United StatesSite Not Available
California Research Foundation
San Diego, California 92123
United StatesSite Not Available
Paragon Rx Clinical Research, Inc
Santa Ana, California 92703
United StatesSite Not Available
Encompass Clinical Research
Spring Valley, California 91978
United StatesSite Not Available
Westlake Medical Research
Thousand Oaks, California 91360
United StatesSite Not Available
Synexus Clinical Research US, Inc.
Vista, California 92083
United StatesSite Not Available
Mountain View Clinical Research
Denver, Colorado 80209
United StatesSite Not Available
New England Research Associates, LLC
Bridgeport, Connecticut 06606
United StatesSite Not Available
CRM of Greater New Haven, LLC
Hamden, Connecticut 06157
United StatesSite Not Available
Stamford Therapeutics Consortium
Stamford, Connecticut 06905
United StatesSite Not Available
Avail Clinical Research, LLC
DeLand, Florida 32720
United StatesSite Not Available
AMB Research Center, Inc
Miami, Florida 33144
United StatesSite Not Available
Allied Biomedical Research Institute
Miami, Florida 33155
United StatesSite Not Available
Lakes Research, LLC
Miami Lakes, Florida 33014
United StatesSite Not Available
Bioclinica Research
Orlando, Florida 32806
United StatesSite Not Available
Gulf Region Clinical Research institute
Pensacola, Florida 32514
United StatesSite Not Available
Integral Rheumatology & Immunology Specialists (IRIS)
Plantation, Florida 33324
United StatesSite Not Available
Progressive Medical Research
Port Orange, Florida 32127
United StatesSite Not Available
Drug Studies America
Marietta, Georgia 30060
United StatesSite Not Available
Georgia Institute For Clinical Research LLC
Marietta, Georgia 30060
United StatesSite Not Available
North Georgia Clinical Research
Woodstock, Georgia 30189
United StatesSite Not Available
Chicago Clinical Research Institute, Inc
Chicago, Illinois 60607
United StatesSite Not Available
Affinity Clinical Research Institute
Oak Lawn, Illinois 60453
United StatesSite Not Available
Clinical Research Advantage, Inc.
Evansville, Indiana 47714
United StatesSite Not Available
MediSphere Medical Research Center, LLC
Evansville, Indiana 47714
United StatesSite Not Available
L-MARC Research Center
Louisville, Kentucky 40213
United StatesSite Not Available
Tandem Clinical Research
Marrero, Louisiana 70072
United StatesSite Not Available
Tufts Medical Center, Inc.
Boston, Massachusetts 02111
United StatesSite Not Available
Great Lakes Research Group, Inc.
Bay City, Michigan 48706
United StatesSite Not Available
Onyx Clinical Research
Caro, Michigan 48723
United StatesSite Not Available
Radiant Research, Inc.
Edina, Minnesota 55435
United StatesSite Not Available
Synexus Clinical Research US, Inc.
Richfield, Minnesota 55423
United StatesSite Not Available
Skyline Medical Center /Radiant Research, Inc.
Elkhorn, Nebraska 68022
United StatesSite Not Available
Meridian Clinical Research Associates, LLC
Omaha, Nebraska 68134
United StatesSite Not Available
Robert Kaplan, D.O.
Las Vegas, Nevada 89144
United StatesSite Not Available
Amici Clinical Research, LLC
Raritan, New Jersey 08869
United StatesSite Not Available
Amici Clinical Research, LLC
Warren, New Jersey 07059
United StatesSite Not Available
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico 87102
United StatesSite Not Available
Drug Trial Brooklyn
Brooklyn, New York 11230
United StatesSite Not Available
Northwell Health
Great Neck, New York 11021
United StatesSite Not Available
Drug Trials America
Hartsdale, New York 10530
United StatesSite Not Available
Upstate Clinical Research Associates, LLC
Williamsville, New York 14221
United StatesSite Not Available
Carolina Research Center
Shelby, North Carolina 28150
United StatesSite Not Available
PMG Research of Wilmington LLC
Wilmington, North Carolina 28401
United StatesSite Not Available
The Center For Clinical Research
Winston-Salem, North Carolina 27103
United StatesSite Not Available
New Horizons Clinical Research
Cincinnati, Ohio 45242
United StatesSite Not Available
Aventiv Research Inc
Columbus, Ohio 43213
United StatesSite Not Available
DOC Clinical Research
Dayton, Ohio 45432
United StatesSite Not Available
Center for Orthopaedics and Sports Medicine
Indiana, Pennsylvania 15701
United StatesSite Not Available
Radiant Research, Inc.
Anderson, South Carolina 29621
United StatesSite Not Available
Piedmont Comprehensive Pain Management Group
Greenville, South Carolina 29601
United StatesSite Not Available
Radiant Research, Inc.
Greer, South Carolina 29651
United StatesSite Not Available
Piedmont Research Partners, LLC
Indian Land, South Carolina 29707
United StatesSite Not Available
Coastal Carolina Research Center at LowCountry Orthopaedics
North Charleston, South Carolina 29406
United StatesSite Not Available
ACME Research, LLC
Orangeburg, South Carolina 29118
United StatesSite Not Available
Office of Dr.Ramesh C. Gupta MD
Memphis, Tennessee 38119
United StatesSite Not Available
West Texas Clinical Research
Lubbock, Texas 79410
United StatesSite Not Available
Clinical Investigations Of Texas
Plano, Texas 75075
United StatesSite Not Available
Synexus USA
Plano, Texas 75093
United StatesSite Not Available
Charlottesville Medical Research Center LLC
Charlottesville, Virginia 22911
United StatesSite Not Available
Health Research of Hampton Roads, Inc
Newport News, Virginia 23606
United StatesSite Not Available
Spokane Joint Replacement Center
Spokane, Washington 99218
United StatesSite Not Available
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