Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
NCT ID: NCT02528188
Last Updated: 2020-01-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3021 participants
INTERVENTIONAL
2015-07-21
2019-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
NSAID
Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
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
Tanezumab 2.5 mg
Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks
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
Tanezumab 5 mg
Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks
Interventions
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NSAID
Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
Tanezumab 2.5 mg
Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks
Tanezumab 5 mg
Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Central Alabama Research
Birmingham, Alabama, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Alabama Orthopaedic Surgeons
Birmingham, Alabama, United States
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Ferguson Family Medicine
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Valley Pain Consultants
Scottsdale, Arizona, United States
Clinical Research Consortium
Tempe, Arizona, United States
Noble Clinical Research, LLC
Tucson, Arizona, United States
Quality of Life Medical & Research Centers, LLC
Tucson, Arizona, United States
Tucson Orthopaedic Institute - Research Center
Tucson, Arizona, United States
CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas, United States
Chrystal Johnson
Little Rock, Arkansas, United States
KLR Business Group, Inc., dba Arkansas Clinical Research
Little Rock, Arkansas, United States
Larry Watkins, MD
Little Rock, Arkansas, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Orange County Research Institute
Anaheim, California, United States
Advanced Research Center
Anaheim, California, United States
CITrials
Bellflower, California, United States
Osteoporosis Medical Center
Beverly Hills, California, United States
Hope Clinical Research
Canoga Park, California, United States
Med Center
Carmichael, California, United States
Core Healthcare Group
Cerritos, California, United States
Pleitez Medical Clinic
Covina, California, United States
Triwest Research Associates, LLC
El Cajon, California, United States
T. Joseph Raoof MD, INC/Encino Research Center
Encino, California, United States
San Diego Imaging Escondido
Escondido, California, United States
Med Investigations, Inc.
Fair Oaks, California, United States
Research Center of Fresno, Inc.
Fresno, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
Collaborative Neuroscience Network, LLC.
Garden Grove, California, United States
Allied Clinical Research
Gold River, California, United States
HealthCare Partners Clinical Research, LLC.
Huntington Beach, California, United States
Marvel Clinical Research LLC
Huntington Beach, California, United States
BioSolutions Clinical Research Center
La Mesa, California, United States
eStudySite
La Mesa, California, United States
Arthritis & Osteoporosis Medical Center
La Palma, California, United States
Center For United Research, Inc.
Lakewood, California, United States
Collaborative Neuroscience Network, LLC.
Long Beach, California, United States
Aeon Research, Inc.
Los Angeles, California, United States
American Institute of Research
Los Angeles, California, United States
InterMed Medical Group
Los Angeles, California, United States
IMD Medical Group
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Providence Clinical Research
North Hollywood, California, United States
Renaissance Imaging Medical Associates, Inc
Northridge, California, United States
NRC Research Institute
Orange, California, United States
Advances in Medicine
Palm Desert, California, United States
Probe Clinical Research Corporation
Riverside, California, United States
University of California, Davis Health System
Sacramento, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Clinical Trials Research
Sacramento, California, United States
Northern California Research
Sacramento, California, United States
Center for Clinical Trials of Sacramento, Inc.
Sacramento, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
San Diego Imaging, Kearny Mesa
San Diego, California, United States
Sharp and Children's MRI Center, LLC
San Diego, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
CITrials
Santa Ana, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Shariar Cohen, MD Corp.
Thousand Oaks, California, United States
Westlake Medical Research
Thousand Oaks, California, United States
Bayview Research Group
Valley Village, California, United States
Renaissance Imaging Medical Associates, Inc
Van Nuys, California, United States
Buhay & Maglunog MDS
West Covina, California, United States
Prohealth Advanced Imaging
West Hills, California, United States
Advanced Rx Clinical Research Group, Inc
Westminster, California, United States
Medvin Clinical Research
Whittier, California, United States
Elite Clinical Trials
Wildomar, California, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, United States
Mountain View Clinical Research, Inc
Denver, Colorado, United States
New England Research Associates, LLC
Bridgeport, Connecticut, United States
Clinical Research Center of CT
Danbury, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Delaware Arthritis
Lewes, Delaware, United States
Javed Rheumatology Associates, Inc.
Newark, Delaware, United States
JEM Research Institute
Atlantis, Florida, United States
AARDS Research, Inc.
Aventura, Florida, United States
RASF-Clinical Research, Inc
Boca Raton, Florida, United States
Orthopedic Research Institute
Boynton Beach, Florida, United States
Meridien Research
Brooksville, Florida, United States
Orthopaedic Associates of West Florida
Clearwater, Florida, United States
Tampa Bay Medical Research, Inc
Clearwater, Florida, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
S&W Clinical Research
Fort Lauderdale, Florida, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States
Clinical Physiology Associates
Fort Myers, Florida, United States
IMA
Fort Myers, Florida, United States
SIMEDHealth, LLC
Gainesville, Florida, United States
South Florida Clinical Trials
Hialeah, Florida, United States
Pines Clinical Research Inc.
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Care Partners Clinical Research
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Columbus Clinical Services LLC
Miami, Florida, United States
Pharmax Research Clinic, Inc.
Miami, Florida, United States
Clintex Research Group
Miami, Florida, United States
Center for Arthritis and Rheumatic Diseases
Miami, Florida, United States
Larkin Imaging Center
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
M&M Medical Center, Inc.
Miami, Florida, United States
Quality Research & Medical Center LLC
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
American Family Medical
Ocala, Florida, United States
Sensible Healthcare, LLC.
Ocoee, Florida, United States
Journey Research, Inc.
Oldsmar, Florida, United States
Sunshine Research Center
Opa-locka, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Rheumatology Associates of Central Florida, P.A.
Orlando, Florida, United States
Omega Research Consultants, LLC
Orlando, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Pensacola Research Consultants, Inc., d.b.a. Avanza Medical Research Center
Pensacola, Florida, United States
Sacred Heart Orthopedics
Pensacola, Florida, United States
Orthopaedic Center of South Florida
Plantation, Florida, United States
St. Johns Center for Clinical Research
Ponte Vedra, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Accord Clinical Research, LLC
Port Orange, Florida, United States
Gulfcoast Research Institute, LLC
Sarasota, Florida, United States
Kennedy White Orthopaedic Center
Sarasota, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Precision Clinical Research, LLC.
Sunrise, Florida, United States
Phoenix Clinical Research, LLC.
Tamarac, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
BayCare Medical Group, Inc
Tampa, Florida, United States
Compass Research North LLC
The Villages, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Perimeter Institute for Clinical Research, Inc. DBA:/PICR Clinic
Atlanta, Georgia, United States
Masters of Clinical Research, Inc.
Augusta, Georgia, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, United States
Arthritis Center of North Georgia
Gainesville, Georgia, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
Drug Studies America
Marietta, Georgia, United States
Better Health Clinical Research, Inc.
Newnan, Georgia, United States
Atlanta Orthopaedic Institute, LLC
Stockbridge, Georgia, United States
Herman Clinical Research, LLC
Suwanee, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
North Georgia Internal Medicine
Woodstock, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Idaho Sports Medicine Institute
Boise, Idaho, United States
Injury Care Research, LLC
Boise, Idaho, United States
Institute Of Arthritis Research
Idaho Falls, Idaho, United States
Advanced Clinical Research
Meridian, Idaho, United States
Medex Healthcare Research, Inc.
Chicago, Illinois, United States
Chicago Clinical Research Institute Inc.
Chicago, Illinois, United States
Northwestern Memorial Hospital-Arkes Pavilion, Diagnostic Testing Center
Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Affinity Clinical Research Institute
Oak Lawn, Illinois, United States
Southwest Center for Healthy Joints, S.C.
Oak Lawn, Illinois, United States
Methodist Research Administration Office
Peoria, Illinois, United States
UnityPoint Clinic Rheumatology
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OrthoIllinois
Rockford, Illinois, United States
Quest Diagnostics
Rockford, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Buynak Clinical Research, P.C.
Valparaiso, Indiana, United States
Mid-America Physiatrists, P.A.
Overland Park, Kansas, United States
Phoenix Medical Research, Inc.
Prairie Village, Kansas, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Otrimed Corporation
Edgewood, Kentucky, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Baton Rouge General Medical Center-Internal Medicine Clinic
Baton Rouge, Louisiana, United States
Baton Rouge General Medical Center-Midcity
Baton Rouge, Louisiana, United States
Baton Rouge General Medical Center-Bluebonnet
Baton Rouge, Louisiana, United States
Baton Rouge General Medical Center-Clinical Trials Office
Baton Rouge, Louisiana, United States
Centex Studies, Inc.
Lake Charles, Louisiana, United States
Klein & Associates, M.D., P.A.
Cumberland, Maryland, United States
Arthritis Treatment Center
Frederick, Maryland, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, United States
MedVadis Research Corporation
Watertown, Massachusetts, United States
Great Lakes Research Group, Incorporated
Bay City, Michigan, United States
Onyx Clinical Research
Caro, Michigan, United States
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, United States
June D.O. PC
Lansing, Michigan, United States
Great Lakes Research Group
Pinconning, Michigan, United States
Michigan Orthopaedic Spine Surgeons
Rochester Hills, Michigan, United States
Medical Research Associates Inc.
Traverse City, Michigan, United States
Oakland Medical Research Center
Troy, Michigan, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Landmark Internal Medicine
Southaven, Mississippi, United States
University of Missouri Health Care-Investigational Pharmacy
Columbia, Missouri, United States
University of Missouri Health Care
Columbia, Missouri, United States
University of Missouri School of Medicine- Clinical Research Center
Columbia, Missouri, United States
Advance Clinical Research, Inc.
St Louis, Missouri, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Affiliated Clinical Research, Inc.
Las Vegas, Nevada, United States
Impact Clinical Trials
Las Vegas, Nevada, United States
Office of Stephen H. Miller, MD
Las Vegas, Nevada, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Office of Robert P. Kaplan, DO
Las Vegas, Nevada, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
G. Timothy Kelly, MD
Las Vegas, Nevada, United States
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, United States
Ocean Rheumatology, PA
Toms River, New Jersey, United States
Premier Research
Trenton, New Jersey, United States
Arthritis, Rheumatic and Back Disease Associates, PA
Voorhees Township, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States
Lovelace Scientific Resources Inc.
Albuquerque, New Mexico, United States
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, United States
Drug Trials Brooklyn
Brooklyn, New York, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Drug Trials America
Hartsdale, New York, United States
NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center, Infusion Center
Lake Success, New York, United States
NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center
Lake Success, New York, United States
NYU Langone Rheumatology Associates Long Island
Lake Success, New York, United States
Lenox Hill Radiology
New York, New York, United States
Manhattan Medical Research Practice PLLC
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
AAIR Research Center
Rochester, New York, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, United States
Northstate Clinical Research, PLLC
Lenoir, North Carolina, United States
Wake Internal Medicine Consultants, Inc
Raleigh, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Lillestol Research, LLC
Fargo, North Dakota, United States
Plains Clinical Research Center, LLC
Fargo, North Dakota, United States
Valley Medical Research/Valley Medical Primary Care
Centerville, Ohio, United States
Hightop Medical Research Center
Cincinnati, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Remington-Davis, Incorporated
Columbus, Ohio, United States
Optimed Research LTD
Columbus, Ohio, United States
Dayton Clinical Research
Dayton, Ohio, United States
PriMed Clinical Research
Dayton, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Springboro Health Center
Springboro, Ohio, United States
AC Clinical Research
Tiffin, Ohio, United States
Glendale Medical Center
Toledo, Ohio, United States
Bone Joint & Spine Surgeons, Inc.
Toledo, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
University Orthopedics Center
Altoona, Pennsylvania, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
The Clinical Trial Center LLC
Jenkintown, Pennsylvania, United States
Founders Research Corporation
Philadelphia, Pennsylvania, United States
The Arthritis Group
Philadelphia, Pennsylvania, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, United States
Main Street Physician's Care - Waterway
Little River, South Carolina, United States
Main Street Physician's Care - Loris
Loris, South Carolina, United States
North Myrtle Beach Family Practice
North Myrtle Beach, South Carolina, United States
Clinical Research Solutions
Jackson, Tennessee, United States
Physicians Quality Care
Jackson, Tennessee, United States
PMG Research, Inc. d/b/a PMG Research of Knoxville
Jefferson City, Tennessee, United States
PCET Research Center, LLC
Knoxville, Tennessee, United States
Diagnostic Imaging PC
Memphis, Tennessee, United States
ARC Clinical Research at Wilson Parke
Austin, Texas, United States
Tekton Research, Inc.
Austin, Texas, United States
Urgent Care MD's
Baytown, Texas, United States
Texas Orthopedic Specialists, PLLC
Bedford, Texas, United States
Galenos Research
Dallas, Texas, United States
Abigail R. Neiman, MD, PA
Houston, Texas, United States
Advances in Health
Houston, Texas, United States
Mercury Clinical Research, Inc.
Houston, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
Memorial Pulmonology
Houston, Texas, United States
BI Research Center
Houston, Texas, United States
Clinical Investigations of Texas
Plano, Texas, United States
ClinRX Research
Richardson, Texas, United States
Quality Research, Inc.
San Antonio, Texas, United States
Lee Medical Associates PA
San Antonio, Texas, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Panacea Clinical Research
San Antonio, Texas, United States
Accurate Clinical Research Inc.
San Antonio, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Victorium Clinical Research
San Antonio, Texas, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States
South Texas Radiology Imaging Centers
San Antonio, Texas, United States
Envision Imaging
Southlake, Texas, United States
Oakbend Medical Center
Sugar Land, Texas, United States
ClinPoint Trials
Waxahachie, Texas, United States
Mercury Clinical Research
Webester, Texas, United States
Clinics of North Texas
Wichita Falls, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Granger Medical Clinic-Riverton
Riverton, Utah, United States
Millennium Clinical Trials, LLC
Arlington, Virginia, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States
Millennium Clinical Trials
Fairfax, Virginia, United States
National Clinical Research-Norfolk, Inc.
Norfolk, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Optimed Research, LTD
Bellingham, Washington, United States
Swedish Medical Center Investigational Drug Services Pharmacy
Seattle, Washington, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Genesis Research Services
Broadmeadow, New South Wales, Australia
Hunter Imaging Group
Cardiff, New South Wales, Australia
Optimus Clinical Research Pty Ltd
Kogarah, New South Wales, Australia
Southern Radiology
Miranda, New South Wales, Australia
Royal Hospital for Women
Randwick, New South Wales, Australia
Castlereagh Imaging
St Leonards, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Australian Clinical Research Network
Sydney, New South Wales, Australia
Spectrum Medical Imaging
Sydney, New South Wales, Australia
AusTrials Pty Ltd
Sherwood, Queensland, Australia
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
Royal Adelaide Hospital Pharmacy
Adelaide, South Australia, Australia
Bensons Radiology
North Adelaide, South Australia, Australia
Emeritus Research
Camberwell, Victoria, Australia
Capital Radiology-Malvern
Melbourne, Victoria, Australia
Capital Radiology-Clayton
Melbourne, Victoria, Australia
SKG Radiology Hollywood
Nedlands, Western Australia, Australia
RK Will Pty Ltd
Victoria Park, Western Australia, Australia
CMIP-Centro Mineiro de Pesquisa LTDA
Juiz de Fora, Minas Gerais, Brazil
CCBR - Centro de Pesquisas e Analises Clinicas LTDA
Rio de Janeiro, Rio de Janeiro, Brazil
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
São Paulo, São Paulo, Brazil
Diagnostic Consultative Center "Sveti Georgi" EOOD
Plovdiv, , Bulgaria
Medical Center "Health for all" - EOOD
Plovdiv, , Bulgaria
UMHAT Kaspela - EOOD Rheumatology Clinic
Plovdiv, , Bulgaria
UMHAT Kaspela - EOOD
Plovdiv, , Bulgaria
"Medical Center Teodora" EOOD
Rousse, , Bulgaria
Diagnostic Consultative Center 17 Sofia EOOD
Sofia, , Bulgaria
UMHAT Sveti Ivan Rilski- EAD
Sofia, , Bulgaria
UMHAT "Sofiamed" OOD, Block 2
Sofia, , Bulgaria
"Medical Center- Dr. Hayvazov" EOOD
Sofia, , Bulgaria
Centro Integral de Reumatologia Reumalab S.A.S.
Medellín, Antioquia, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS CIREEM SAS
Bogotá, Bogota DC, Colombia
Medicinski centar Kuna&Peric
Zagreb, , Croatia
National Hospital Organization Toyohashi Medical Center
Toyohashi, Aichi-ken, Japan
Funabashi Municipal Medical Center
Funabashi, Chiba, Japan
Matsudo City General Hospital
Matsudo, Chiba, Japan
Kanbara Clinic
Kitakyushu, Fukuoka, Japan
Hidaka Orthopedic Hospital
Kurume, Fukuoka, Japan
Obase Hospital
Miyako-gun, Fukuoka, Japan
Himeno Hospital
Yamegun, Fukuoka, Japan
Ikeda Kinen Hospital
Sukagawa, Fukushima, Japan
Zenshukai Hospital
Maebashi, Gunma, Japan
Mazda Hospital
Aki-gun, Hiroshima, Japan
Medical Corporation Okimoto Clinic
Kure, Hiroshima, Japan
Medical Corporation Emu Emukai, Matterhorn Rehabilitation Hospital
Kure, Hiroshima, Japan
Takahashi Orthopedics Clinic
Chitose, Hokkaido, Japan
Obihiro Orthopaedic Hospital
Obihiro, Hokkaido, Japan
Okubo Hospital
Akashi, Hyōgo, Japan
Omuro Orthopedic Clinic
Himeji, Hyōgo, Japan
Medical corporate corporation hoshikai Onishi medical clinic
Kako-gun, Hyōgo, Japan
Kobe Red Cross Hospital
Kobe, Hyōgo, Japan
Mito Saiseikai General Hospital
Mito, Ibaraki, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa-ken, Japan
Kokan Clinic
Kawasaki, Kanagawa, Japan
Misugikai Medical Corporation Otokoyama Hospital
Yawata, Kyoto, Japan
Nakajo Orthopedic Clinic
Sendai, Miyagi, Japan
Marunouchi Hospital
Matsumoto, Nagano, Japan
Oita University Hospital
Yufu, Oita Prefecture, Japan
Sobajima Clinic/Orthopedics
Higashiosaka, Osaka, Japan
Rinku General Medical Center
Izumisano, Osaka, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
Social Welfare Organization Saiseikai Imperial Gift Foundation,Inc. Osaka Saiseikai Nakatsu Hospital
Osaka, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Shimane University Hospital
Izumo, Shimane, Japan
Fujieda Municipal General Hospital
Fujieda, Shizuoka, Japan
JA Shizuoka Kohseiren Enshu Hospital
Hamamatsu, Shizuoka, Japan
Japanese Red Cross Hamamatsu Hospital
Hamamatsu, Shizuoka, Japan
Sonodakai Joint Replacement Center Hospital
Adachi-ku, Tokyo, Japan
Medical Plaza Edogawa
Edogawa-ku, Tokyo, Japan
Sato Orthopaedic Clinic
Edogawa-ku, Tokyo, Japan
Fussa Hospital
Fussa, Tokyo, Japan
Jukoukai hospital
Koto-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan
Tamagawa Hospital
Setagaya-ku, Tokyo, Japan
Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital
Shinagawa-ku, Tokyo, Japan
Ohimachi Orthopaedic Clinic
Shinagawa-ku, Tokyo, Japan
Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
Yonago, Tottori, Japan
National Hospital Organization Chiba Medical Center
Chiba, , Japan
Chihaya Hospital
Fukuoka, , Japan
Kuroda Orthopedic Hospital
Fukuoka, , Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, , Japan
Hiroshima Prefectural Hospital
Hiroshima, , Japan
Kumamoto Orthopaedic Hospital
Kumamoto, , Japan
Nagayoshi General Hospital
Osaka, , Japan
Iwasaki Orthopedic Surgery
Saitama, , Japan
Saitama Municipal Hospital
Saitama, , Japan
Saules seimos medicinos centras
Kaunas, , Lithuania
Klaipeda University Hospital
Klaipėda, , Lithuania
Republican Siauliai Hospital
Šiauliai, , Lithuania
Centro Hospitalario Mac, S.A. de C.V.
Guadajara, Jalisco, Mexico
Consultorio Medico del Dr. Federico Galvan Villegas
Guadalajara, Jalisco, Mexico
Lakeland Clinical Trials
Rotorua, BOP, New Zealand
Otago Radiology
Dunedin, Otago, New Zealand
RMC Medical Research Ltd
Dunedin, Otago, New Zealand
South Pacific Clinical Trials
Auckland, , New Zealand
TRG Imaging Lincoln Road
Auckland, , New Zealand
Auckland Bone Density Ltd
Auckland, , New Zealand
North Shore Hospital, Waitemata District Health Board
Auckland, , New Zealand
Star Unit, North Shore Hospital, Waitemata District Health Board
Auckland, , New Zealand
The Radiology Group
Auckland, , New Zealand
Southern Clinical Trials- Waitemata Ltd
Auckland, , New Zealand
Auckland Bone Density
Auckland, , New Zealand
Optimal Clinical Trials
Auckland, , New Zealand
Auckland Radiology Parnell Branch
Auckland, , New Zealand
Southern Clinical Trials Ltd
Christchurch, , New Zealand
Collingwood Street Pharmacy
Nelson, , New Zealand
Nelson Radiology
Nelson, , New Zealand
Porter Rheumatology Ltd
Nelson, , New Zealand
Bay Radiology
Tauranga, , New Zealand
P3 Research Ltd
Tauranga, , New Zealand
Clinical Horizons NZ Ltd
Tauranga, , New Zealand
P3 Research Ltd
Wellington, , New Zealand
Pacific Radiology
Wellington, , New Zealand
Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios
Cayma, Arequipa, Peru
Centro De Investigacion Clinica Trujillo EIRL/Clinica Peruano Americana S.A.
Trujillo, La Libertad, Peru
ABK REUMA S.R.L. de Medicentro Biociencias/BIO CIENCIAS PERU S.R.L.
Lima, , Peru
Centro de Investigación Reumatología CAA-Clinica Anglo Americana
Lima, , Peru
Investigaciones en Reumatologia / Centro Medico Corpac S.A.
Lima, , Peru
Centro de Investigaciones Medicas-Hospital Maria Auxiliadora
Lima, , Peru
Investigaciones Clinicas S.A.C. / Instituto de Ginecologia y Reproduccion S.A.
Lima, , Peru
Investigaciones Clinicas S.A.C./Instituto de Ginecologia y Reproduccion S.A.
Lima, , Peru
Philippine General Hospital
Manila, NCR, Philippines
Manila Doctors Hospital
Manila, , Philippines
Moscow Municipal Rheumatology Center
Moscow, , Russia
SBHI "City Clinical Hospital No. 1 n.a N.I. Pirogov"
Moscow, , Russia
SBHI "City Clinical Hospital No. 1 n.a. N.I. Pirogov"
Moscow, , Russia
Federal State Budgetary Scientific Research institution of fundamental and clinical immunology
Novosibirsk, , Russia
Federal State Budgetary Scientific Institution
Novosibirsk, , Russia
State Budgetary Institution of Ryazan Region
Ryazan, , Russia
Medical Technologies Ltd
Saint Petersburg, , Russia
Limited Liability Company "Medical Center "Reavita Med SPb"
Saint Petersburg, , Russia
Medinet LLC
Saint Petersburg, , Russia
FSBI 'SRITO n.a. R.R. Vreden' MoH RF
Saint Petersburg, , Russia
Institute for Rehabilitation
Belgrade, , Serbia
Institute of Rheumatology
Belgrade, , Serbia
Institute for treatment and rehabilitation "Niska Banja"
Niška Banja, , Serbia
Special Hospital for Rheumatic Diseases Novi Sad
Novi Sad, , Serbia
General hospital "Dr Laza K. Lazarevic" Sabac
Šabac, , Serbia
Reumatologia s.r.o.
Bratislava, , Slovakia
Nestatna Reumatologicka Ambulancia, Poliklinika Karlova Ves
Bratislava, , Slovakia
MUDr. STRANAI s.r.o.
Košice, , Slovakia
Reum.hapi s.r.o.
Nové Mesto nad Váhom, , Slovakia
MEDIPA s.r.o.
Piešťany, , Slovakia
Thermium s.r.o.
Piešťany, , Slovakia
Daegu Catholic University Medical Center
Daegu, , South Korea
Department of Radiology
Daegu, , South Korea
Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Clinical Trial Center Pharmacy
Daejeon, , South Korea
Department of Radiology
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Department of Radiology
Gwangju, , South Korea
Pharmacy of Clinical Trial Center
Gwangju, , South Korea
Clinical Trial Pharmacy
Seoul, , South Korea
Department of Radiology
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Clinical Trials Center Pharmacy
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Clinical Trial Center Pharmacy
Seoul, , South Korea
Department of Radiology
Seoul, , South Korea
Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Clinical Research Pharmacy
Seoul, , South Korea
Department of Clinical Research Pharmacy, Konkuk University Medical Center
Seoul, , South Korea
Department of Radiology
Seoul, , South Korea
Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Clinical Trial Center Pharmacy
Seoul, , South Korea
Department of Orthopedic Surgery, Samsung Medical Center
Seoul, , South Korea
Clinical Trial Pharmacy
Seoul, , South Korea
Department of Radiology
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Clinical Research Pharmacy, SMG SNU Boramae Medical Center
Seoul, , South Korea
Department of Clinical Research Pharmacy, SMG-SNU Boramae Medical Center
Seoul, , South Korea
Department of Radiology
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Department of Radiology
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Clinical Trial Pharmacy
Yangcheon-gu, Seoul, , South Korea
Changhua Christian Hospital Clinical Trial Pharmacy
Changhua, , Taiwan
Changhua Christian Hospital
Changhua, , Taiwan
Chang Gung Memorial Hospital-Kaohsiung Branch Clinical Trial Pharmacy
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital-Kaohsiung Branch
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital Clinical Trial Pharmacy
Taichung, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Department of Pharmacy, China Medical University Hospital
Taichung, , Taiwan
Regional Communal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi, , Ukraine
Communal Non-profit Institution "City Clinical Hospital No.27" of Kharkiv City Council
Kharkiv, , Ukraine
Government Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"
Kharkiv, , Ukraine
Chair of Internal Medicine #2
Kyiv, , Ukraine
Oleksandrivska Clinical Hospital Of Kyiv
Kyiv, , Ukraine
Kyiv City Clinical Hospital 3,Rheumatology Department
Kyiv, , Ukraine
Clinic of NI "NSC"M.D.Strazhesko Institute of Cardiology" of NAMS of Ukraine,
Kyiv, , Ukraine
Polyclinic of Administration of Medical Services and Rehabilitation of State Stock Holding Company
Kyiv, , Ukraine
Clinic of SI "Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine"
Kyiv, , Ukraine
Clinic of SI Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine
Kyiv, , Ukraine
National Medical University named after O O Bogomolets,
Kyiv, , Ukraine
Polyclinic Of Administration of Medical Services and Rehabilitation of SSHC Artem
Kyiv, , Ukraine
Communal Non-profit Institution "City Clinical Hospital #5 of Lviv", Therapeutics Department
Lviv, , Ukraine
Communal Institution "Odesa Regional Clinical Hospital"
Odesa, , Ukraine
Multi-field Medical Center (University Clinic No.1) of Odesa National Medical University,
Odesa, , Ukraine
Communal Institution Ternopil University Hospital
Ternopil, , Ukraine
Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov, Rheumatology Department,
Vinnytsia, , Ukraine
Communal Non-commercial Enterprise "Vinnytsia City Clinical Hospital No 1"
Vinnytsia, , Ukraine
Medical Clinical Investigational Centre of Medical Centre Health Clinic LTD
Vinnytsia, , Ukraine
Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Medical
Vinnytsia, , Ukraine
Vinnytsya Medical National University named after M.I. Pyrogov, Chair of Internal Medicine #3
Vinnytsia, , Ukraine
Communal Institution Zaporizhzhya Regional Clinical Hospital
Zaporizhzhya, , Ukraine
Countries
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References
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Schnitzer TJ, Conaghan PG, Berenbaum F, Abraham L, Cappelleri JC, Bushmakin AG, Viktrup L, Yang R, Brown MT. Effect size varies based on calculation method and may affect interpretation of treatment effect: an illustration using randomised clinical trials in osteoarthritis. Adv Rheumatol. 2024 Apr 22;64(1):31. doi: 10.1186/s42358-024-00358-y.
Guermazi A, Roemer FW, Kompel AJ, Diaz LE, Crema MD, Brown MT, Hickman A, Pixton GC, Viktrup L, Fountaine RJ, Burr A, Sherlock SP, West CR. Inter-Reader Consistency and Exclusionary Findings During Radiographic Screening for Phase 3 Trials of Tanezumab in Patients With Osteoarthritis. Osteoarthr Imaging. 2022 Sep-Dec;2(3-4):100082. doi: 10.1016/j.ostima.2022.100082. Epub 2022 Nov 15.
Carrino JA, McAlindon TE, Schnitzer TJ, Guermazi A, Hochberg MC, Conaghan PG, Brown MT, Burr A, Fountaine RJ, Pixton GC, Viktrup L, Verburg KM, West CR. Characterization of adverse joint outcomes in patients with osteoarthritis treated with subcutaneous tanezumab. Osteoarthritis Cartilage. 2023 Dec;31(12):1612-1626. doi: 10.1016/j.joca.2023.08.010. Epub 2023 Aug 29.
Shoji S, Suzuki A, Nouri P, Cai CH, Gaitonde P, Marshall S. Prediction of relative change in free nerve growth factor following subcutaneous administration of tanezumab, a novel monoclonal antibody to nerve growth factor. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1358-1370. doi: 10.1002/psp4.13015. Epub 2023 Jul 31.
Hunter DJ, Schnitzer TJ, Hall J, Semel D, Davignon I, Cappelleri JC, Bushmakin AG, Abraham L. Time to first and sustained improvement in WOMAC domains among patients with osteoarthritis receiving tanezumab. Osteoarthr Cartil Open. 2022 Jul 2;4(3):100294. doi: 10.1016/j.ocarto.2022.100294. eCollection 2022 Sep.
Atkinson J, Edwards RA, Bonfanti G, Barroso J, Schnitzer TJ. A Two-Step, Trajectory-Focused, Analytics Approach to Attempt Prediction of Analgesic Response in Patients with Moderate-to-Severe Osteoarthritis. Adv Ther. 2023 Jan;40(1):252-264. doi: 10.1007/s12325-022-02336-6. Epub 2022 Oct 27.
Mease P, Kuritzky L, Wright WL, Mallick-Searle T, Fountaine R, Yang R, Sadrarhami M, Faison W, Johnston E, Viktrup L. Efficacy and safety of tanezumab, NSAIDs, and placebo in patients with moderate to severe hip or knee osteoarthritis and a history of depression, anxiety, or insomnia: post-hoc analysis of phase 3 trials. Curr Med Res Opin. 2022 Nov;38(11):1909-1922. doi: 10.1080/03007995.2022.2113689. Epub 2022 Aug 28.
Schnitzer TJ, Bonfanti G, Atkinson J, Donevan S, Viktrup L, Barroso J, Whalen E, Edwards RA. Characterizing 16-Week Responder Profiles Using Group-Based Trajectory Modeling in Over 4300 Clinical Trial Participants Receiving Pharmaceutical Treatment for Moderate to Severe Osteoarthritis. Adv Ther. 2022 Oct;39(10):4742-4756. doi: 10.1007/s12325-022-02290-3. Epub 2022 Aug 12.
Neogi T, Hunter DJ, Churchill M, Shirinsky I, White A, Guermazi A, Omata M, Fountaine RJ, Pixton G, Viktrup L, Brown MT, West CR, Verburg KM. Observed efficacy and clinically important improvements in participants with osteoarthritis treated with subcutaneous tanezumab: results from a 56-week randomized NSAID-controlled study. Arthritis Res Ther. 2022 Mar 29;24(1):78. doi: 10.1186/s13075-022-02759-0.
Conaghan PG, Dworkin RH, Schnitzer TJ, Berenbaum F, Bushmakin AG, Cappelleri JC, Viktrup L, Abraham L. WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee. J Rheumatol. 2022 Jun;49(6):615-621. doi: 10.3899/jrheum.210543. Epub 2022 Mar 1.
Brown MT, Sandroni P, Low PA, Gorson KC, Hunter DJ, Pixton GC, Fountaine RJ, Viktrup L, West CR, Verburg KM. Neurological safety of subcutaneous tanezumab versus NSAID in patients with osteoarthritis. J Neurol Sci. 2022 Mar 15;434:120184. doi: 10.1016/j.jns.2022.120184. Epub 2022 Feb 14.
Hochberg MC, Carrino JA, Schnitzer TJ, Guermazi A, Walsh DA, White A, Nakajo S, Fountaine RJ, Hickman A, Pixton G, Viktrup L, Brown MT, West CR, Verburg KM. Long-Term Safety and Efficacy of Subcutaneous Tanezumab Versus Nonsteroidal Antiinflammatory Drugs for Hip or Knee Osteoarthritis: A Randomized Trial. Arthritis Rheumatol. 2021 Jul;73(7):1167-1177. doi: 10.1002/art.41674. Epub 2021 Jun 7.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Other Identifiers
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2012-003721-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OA SAFETY STUDY
Identifier Type: OTHER
Identifier Source: secondary_id
A4091058
Identifier Type: -
Identifier Source: org_study_id
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