NCT02528188

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
3,021

participants targeted

Target at P75+ for phase_3 chronic-pain

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_3 chronic-pain

Geographic Reach
18 countries

507 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

July 21, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 10, 2020

Completed
Last Updated

January 10, 2020

Status Verified

December 1, 2019

Enrollment Period

3.2 years

First QC Date

July 19, 2015

Results QC Date

October 4, 2019

Last Update Submit

January 6, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome

    Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to \[\>=\] 2 millimeters \[mm\]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.

    Baseline up to Week 80

  • Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome

    Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.

    Baseline up to Week 80

  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16

    WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.

    Baseline, Week 16

  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16

    WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.

    Baseline, Week 16

  • Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16

    PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using Interactive Response Technology (IRT), where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.

    Baseline, Week 16

Secondary Outcomes (77)

  • Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome

    Baseline up to Week 80

  • Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome

    Baseline up to Week 80

  • Percentage of Participants With Individual Adjudicated Joint Safety Outcome

    Baseline up to Week 80

  • Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome

    Baseline up to Week 80

  • Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome

    Baseline up to Week 80

  • +72 more secondary outcomes

Study Arms (3)

NSAID

ACTIVE COMPARATOR

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

Drug: NSAID

Tanezumab 2.5 mg

EXPERIMENTAL

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

Biological: Tanezumab 2.5 mg

Tanezumab 5 mg

EXPERIMENTAL

Subcutaneous injection of tanezumab 5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac) twice daily for 56 weeks

Biological: Tanezumab 5 mg

Interventions

NSAIDDRUG

Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks

NSAID

Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks

Tanezumab 2.5 mg
Tanezumab 5 mgBIOLOGICAL

Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks

Tanezumab 5 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (507)

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Alabama Orthopaedic Surgeons

Birmingham, Alabama, 35235, United States

Location

Rheumatology Associates of North Alabama, PC

Huntsville, Alabama, 35801, United States

Location

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Ferguson Family Medicine

Mesa, Arizona, 85215, United States

Location

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, 85032, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Valley Pain Consultants

Scottsdale, Arizona, 85254, United States

Location

Clinical Research Consortium

Tempe, Arizona, 85283, United States

Location

Noble Clinical Research, LLC

Tucson, Arizona, 85704, United States

Location

Quality of Life Medical & Research Centers, LLC

Tucson, Arizona, 85712, United States

Location

Tucson Orthopaedic Institute - Research Center

Tucson, Arizona, 85712, United States

Location

CHI St. Vincent Medical Group Hot Springs

Hot Springs, Arkansas, 71913, United States

Location

Chrystal Johnson

Little Rock, Arkansas, 72205, United States

Location

KLR Business Group, Inc., dba Arkansas Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Larry Watkins, MD

Little Rock, Arkansas, 72205, United States

Location

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72205, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

Advanced Research Center

Anaheim, California, 92805, United States

Location

CITrials

Bellflower, California, 90706, United States

Location

Osteoporosis Medical Center

Beverly Hills, California, 90211, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Med Center

Carmichael, California, 95608, United States

Location

Core Healthcare Group

Cerritos, California, 90703, United States

Location

Pleitez Medical Clinic

Covina, California, 91723, United States

Location

Triwest Research Associates, LLC

El Cajon, California, 92020, United States

Location

T. Joseph Raoof MD, INC/Encino Research Center

Encino, California, 91436, United States

Location

San Diego Imaging Escondido

Escondido, California, 92029, United States

Location

Med Investigations, Inc.

Fair Oaks, California, 95628, United States

Location

Research Center of Fresno, Inc.

Fresno, California, 93702, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

Collaborative Neuroscience Network, LLC.

Garden Grove, California, 92845, United States

Location

Allied Clinical Research

Gold River, California, 95670, United States

Location

HealthCare Partners Clinical Research, LLC.

Huntington Beach, California, 92646, United States

Location

Marvel Clinical Research LLC

Huntington Beach, California, 92647, United States

Location

BioSolutions Clinical Research Center

La Mesa, California, 91941, United States

Location

eStudySite

La Mesa, California, 91942, United States

Location

Arthritis & Osteoporosis Medical Center

La Palma, California, 90723, United States

Location

Center For United Research, Inc.

Lakewood, California, 90805, United States

Location

Collaborative Neuroscience Network, LLC.

Long Beach, California, 90806, United States

Location

Aeon Research, Inc.

Los Angeles, California, 90010, United States

Location

American Institute of Research

Los Angeles, California, 90017, United States

Location

InterMed Medical Group

Los Angeles, California, 90017, United States

Location

IMD Medical Group

Los Angeles, California, 90020, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Renaissance Imaging Medical Associates, Inc

Northridge, California, 91328, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Advances in Medicine

Palm Desert, California, 92260, United States

Location

Probe Clinical Research Corporation

Riverside, California, 92501, United States

Location

University of California, Davis Health System

Sacramento, California, 95817, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Clinical Trials Research

Sacramento, California, 95821, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

Center for Clinical Trials of Sacramento, Inc.

Sacramento, California, 95823, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

San Diego Imaging, Kearny Mesa

San Diego, California, 92123, United States

Location

Sharp and Children's MRI Center, LLC

San Diego, California, 92123, United States

Location

Artemis Institute for Clinical Research

San Marcos, California, 92078, United States

Location

CITrials

Santa Ana, California, 92705, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Shariar Cohen, MD Corp.

Thousand Oaks, California, 91360, United States

Location

Westlake Medical Research

Thousand Oaks, California, 91360, United States

Location

Bayview Research Group

Valley Village, California, 91607, United States

Location

Renaissance Imaging Medical Associates, Inc

Van Nuys, California, 91405, United States

Location

Buhay & Maglunog MDS

West Covina, California, 91790, United States

Location

Prohealth Advanced Imaging

West Hills, California, 91303, United States

Location

Advanced Rx Clinical Research Group, Inc

Westminster, California, 92683, United States

Location

Medvin Clinical Research

Whittier, California, 90602, United States

Location

Elite Clinical Trials

Wildomar, California, 92595, United States

Location

Mountain View Clinical Research, Inc.

Denver, Colorado, 80209, United States

Location

Mountain View Clinical Research, Inc

Denver, Colorado, 80209, United States

Location

New England Research Associates, LLC

Bridgeport, Connecticut, 06606, United States

Location

Clinical Research Center of CT

Danbury, Connecticut, 06810, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Delaware Arthritis

Lewes, Delaware, 19958, United States

Location

Javed Rheumatology Associates, Inc.

Newark, Delaware, 19713, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

AARDS Research, Inc.

Aventura, Florida, 33180, United States

Location

RASF-Clinical Research, Inc

Boca Raton, Florida, 33486, United States

Location

Orthopedic Research Institute

Boynton Beach, Florida, 33472, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

Orthopaedic Associates of West Florida

Clearwater, Florida, 33756, United States

Location

Tampa Bay Medical Research, Inc

Clearwater, Florida, 33761, United States

Location

Midland Florida Clinical Research Center, LLC

DeLand, Florida, 32720, United States

Location

S&W Clinical Research

Fort Lauderdale, Florida, 33306, United States

Location

Centre for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida, 33309, United States

Location

Clinical Physiology Associates

Fort Myers, Florida, 33912, United States

Location

IMA

Fort Myers, Florida, 33912, United States

Location

SIMEDHealth, LLC

Gainesville, Florida, 32607, United States

Location

South Florida Clinical Trials

Hialeah, Florida, 33016, United States

Location

Pines Clinical Research Inc.

Hollywood, Florida, 33024, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Care Partners Clinical Research

Jacksonville, Florida, 32218, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Columbus Clinical Services LLC

Miami, Florida, 33125, United States

Location

Pharmax Research Clinic, Inc.

Miami, Florida, 33126, United States

Location

Clintex Research Group

Miami, Florida, 33135, United States

Location

Center for Arthritis and Rheumatic Diseases

Miami, Florida, 33173, United States

Location

Larkin Imaging Center

Miami, Florida, 33173, United States

Location

New Horizon Research Center

Miami, Florida, 33175, United States

Location

International Research Associates, LLC

Miami, Florida, 33183, United States

Location

M&M Medical Center, Inc.

Miami, Florida, 33185, United States

Location

Quality Research & Medical Center LLC

Miami, Florida, 33186, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

American Family Medical

Ocala, Florida, 34471, United States

Location

Sensible Healthcare, LLC.

Ocoee, Florida, 34761, United States

Location

Journey Research, Inc.

Oldsmar, Florida, 34677, United States

Location

Sunshine Research Center

Opa-locka, Florida, 33054, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Rheumatology Associates of Central Florida, P.A.

Orlando, Florida, 32806, United States

Location

Omega Research Consultants, LLC

Orlando, Florida, 32810, United States

Location

Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States

Location

Pensacola Research Consultants, Inc., d.b.a. Avanza Medical Research Center

Pensacola, Florida, 32503, United States

Location

Sacred Heart Orthopedics

Pensacola, Florida, 32503, United States

Location

Orthopaedic Center of South Florida

Plantation, Florida, 33324, United States

Location

St. Johns Center for Clinical Research

Ponte Vedra, Florida, 32081, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Accord Clinical Research, LLC

Port Orange, Florida, 32129, United States

Location

Gulfcoast Research Institute, LLC

Sarasota, Florida, 34232, United States

Location

Kennedy White Orthopaedic Center

Sarasota, Florida, 34232, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Precision Clinical Research, LLC.

Sunrise, Florida, 33351, United States

Location

Phoenix Clinical Research, LLC.

Tamarac, Florida, 33321, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33603, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

BayCare Medical Group, Inc

Tampa, Florida, 33614, United States

Location

Compass Research North LLC

The Villages, Florida, 32162, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Perimeter Institute for Clinical Research, Inc. DBA:/PICR Clinic

Atlanta, Georgia, 30338, United States

Location

Masters of Clinical Research, Inc.

Augusta, Georgia, 30909, United States

Location

River Birch Research Alliance, LLC

Blue Ridge, Georgia, 30513, United States

Location

Arthritis Center of North Georgia

Gainesville, Georgia, 30501, United States

Location

Center for Advanced Research & Education

Gainesville, Georgia, 30501, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Better Health Clinical Research, Inc.

Newnan, Georgia, 30265, United States

Location

Atlanta Orthopaedic Institute, LLC

Stockbridge, Georgia, 30281, United States

Location

Herman Clinical Research, LLC

Suwanee, Georgia, 30024, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

North Georgia Internal Medicine

Woodstock, Georgia, 30189, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Idaho Sports Medicine Institute

Boise, Idaho, 83706, United States

Location

Injury Care Research, LLC

Boise, Idaho, 83713, United States

Location

Institute Of Arthritis Research

Idaho Falls, Idaho, 83404, United States

Location

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

Medex Healthcare Research, Inc.

Chicago, Illinois, 60602, United States

Location

Chicago Clinical Research Institute Inc.

Chicago, Illinois, 60607, United States

Location

Northwestern Memorial Hospital-Arkes Pavilion, Diagnostic Testing Center

Chicago, Illinois, 60611, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Affinity Clinical Research Institute

Oak Lawn, Illinois, 60453, United States

Location

Southwest Center for Healthy Joints, S.C.

Oak Lawn, Illinois, 60453, United States

Location

Methodist Research Administration Office

Peoria, Illinois, 61602, United States

Location

UnityPoint Clinic Rheumatology

Peoria, Illinois, 61602, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OrthoIllinois

Rockford, Illinois, 61114, United States

Location

Quest Diagnostics

Rockford, Illinois, 61114, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Buynak Clinical Research, P.C.

Valparaiso, Indiana, 46383, United States

Location

Mid-America Physiatrists, P.A.

Overland Park, Kansas, 66210, United States

Location

Phoenix Medical Research, Inc.

Prairie Village, Kansas, 66208, United States

Location

Professional Research Network of Kansas, LLC

Wichita, Kansas, 67205-1138, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Otrimed Corporation

Edgewood, Kentucky, 41017, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Baton Rouge General Medical Center-Internal Medicine Clinic

Baton Rouge, Louisiana, 70806, United States

Location

Baton Rouge General Medical Center-Midcity

Baton Rouge, Louisiana, 70806, United States

Location

Baton Rouge General Medical Center-Bluebonnet

Baton Rouge, Louisiana, 70809, United States

Location

Baton Rouge General Medical Center-Clinical Trials Office

Baton Rouge, Louisiana, 70809, United States

Location

Centex Studies, Inc.

Lake Charles, Louisiana, 70601, United States

Location

Klein & Associates, M.D., P.A.

Cumberland, Maryland, 21502, United States

Location

Arthritis Treatment Center

Frederick, Maryland, 21702, United States

Location

Klein & Associates, M.D., P.A.

Hagerstown, Maryland, 21740, United States

Location

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

Beacon Clinical Research, LLC

Quincy, Massachusetts, 02169, United States

Location

MedVadis Research Corporation

Watertown, Massachusetts, 02472, United States

Location

Great Lakes Research Group, Incorporated

Bay City, Michigan, 48706, United States

Location

Onyx Clinical Research

Caro, Michigan, 48723, United States

Location

Orthopaedic Associates of Michigan, PC

Grand Rapids, Michigan, 49525, United States

Location

June D.O. PC

Lansing, Michigan, 48910, United States

Location

Great Lakes Research Group

Pinconning, Michigan, 48650, United States

Location

Michigan Orthopaedic Spine Surgeons

Rochester Hills, Michigan, 48307, United States

Location

Medical Research Associates Inc.

Traverse City, Michigan, 49686, United States

Location

Oakland Medical Research Center

Troy, Michigan, 48085, United States

Location

Olive Branch Family Medical Center

Olive Branch, Mississippi, 38654, United States

Location

Landmark Internal Medicine

Southaven, Mississippi, 38671, United States

Location

University of Missouri Health Care-Investigational Pharmacy

Columbia, Missouri, 65212, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

University of Missouri School of Medicine- Clinical Research Center

Columbia, Missouri, 65212, United States

Location

Advance Clinical Research, Inc.

St Louis, Missouri, 63109, United States

Location

Medex Healthcare Research, Inc.

St Louis, Missouri, 63117, United States

Location

Physician Research Collaboration, LLC

Lincoln, Nebraska, 68516, United States

Location

Affiliated Clinical Research, Inc.

Las Vegas, Nevada, 89106, United States

Location

Impact Clinical Trials

Las Vegas, Nevada, 89106, United States

Location

Office of Stephen H. Miller, MD

Las Vegas, Nevada, 89117, United States

Location

Clinical Research Consortium

Las Vegas, Nevada, 89119, United States

Location

Office of Robert P. Kaplan, DO

Las Vegas, Nevada, 89119, United States

Location

Advanced Biomedical Research of America

Las Vegas, Nevada, 89123, United States

Location

G. Timothy Kelly, MD

Las Vegas, Nevada, 89128, United States

Location

ActivMed Practices & Research, Inc.

Portsmouth, New Hampshire, 03801, United States

Location

Ocean Rheumatology, PA

Toms River, New Jersey, 08755, United States

Location

Premier Research

Trenton, New Jersey, 08611, United States

Location

Arthritis, Rheumatic and Back Disease Associates, PA

Voorhees Township, New Jersey, 08043, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

New Mexico Clinical Research & Osteoporosis Center, Inc.

Albuquerque, New Mexico, 87106, United States

Location

Lovelace Scientific Resources Inc.

Albuquerque, New Mexico, 87108, United States

Location

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, 11201, United States

Location

Drug Trials Brooklyn

Brooklyn, New York, 11230, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center, Infusion Center

Lake Success, New York, 11042, United States

Location

NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center

Lake Success, New York, 11042, United States

Location

NYU Langone Rheumatology Associates Long Island

Lake Success, New York, 11042, United States

Location

Lenox Hill Radiology

New York, New York, 10016, United States

Location

Manhattan Medical Research Practice PLLC

New York, New York, 10016, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

Upstate Clinical Research Associates, LLC

Williamsville, New York, 14221, United States

Location

Northstate Clinical Research, PLLC

Lenoir, North Carolina, 28645, United States

Location

Wake Internal Medicine Consultants, Inc

Raleigh, North Carolina, 27612, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Lillestol Research, LLC

Fargo, North Dakota, 58103, United States

Location

Plains Clinical Research Center, LLC

Fargo, North Dakota, 58104, United States

Location

Valley Medical Research/Valley Medical Primary Care

Centerville, Ohio, 45459, United States

Location

Hightop Medical Research Center

Cincinnati, Ohio, 45224, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45255, United States

Location

Aventiv Research Inc.

Columbus, Ohio, 43213, United States

Location

Remington-Davis, Incorporated

Columbus, Ohio, 43215, United States

Location

Optimed Research LTD

Columbus, Ohio, 43235, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45406, United States

Location

PriMed Clinical Research

Dayton, Ohio, 45419, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Springboro Health Center

Springboro, Ohio, 45066, United States

Location

AC Clinical Research

Tiffin, Ohio, 44883, United States

Location

Glendale Medical Center

Toledo, Ohio, 43614, United States

Location

Bone Joint & Spine Surgeons, Inc.

Toledo, Ohio, 43623, United States

Location

Health Research of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

Heritage Valley Medical Group, Inc.

Beaver, Pennsylvania, 15009, United States

Location

Brandywine Clinical Research

Downingtown, Pennsylvania, 19335, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

The Clinical Trial Center LLC

Jenkintown, Pennsylvania, 19046, United States

Location

Founders Research Corporation

Philadelphia, Pennsylvania, 19114, United States

Location

The Arthritis Group

Philadelphia, Pennsylvania, 19152, United States

Location

Clinical Research Center of Reading, LLC

Wyomissing, Pennsylvania, 19610, United States

Location

Main Street Physician's Care - Waterway

Little River, South Carolina, 29566, United States

Location

Main Street Physician's Care - Loris

Loris, South Carolina, 29569, United States

Location

North Myrtle Beach Family Practice

North Myrtle Beach, South Carolina, 29582, United States

Location

Clinical Research Solutions

Jackson, Tennessee, 38305, United States

Location

Physicians Quality Care

Jackson, Tennessee, 38305, United States

Location

PMG Research, Inc. d/b/a PMG Research of Knoxville

Jefferson City, Tennessee, 37760, United States

Location

PCET Research Center, LLC

Knoxville, Tennessee, 37909, United States

Location

Diagnostic Imaging PC

Memphis, Tennessee, 38119, United States

Location

ARC Clinical Research at Wilson Parke

Austin, Texas, 78726, United States

Location

Tekton Research, Inc.

Austin, Texas, 78745, United States

Location

Urgent Care MD's

Baytown, Texas, 77521, United States

Location

Texas Orthopedic Specialists, PLLC

Bedford, Texas, 76021, United States

Location

Galenos Research

Dallas, Texas, 75251, United States

Location

Abigail R. Neiman, MD, PA

Houston, Texas, 77024, United States

Location

Advances in Health

Houston, Texas, 77030, United States

Location

Mercury Clinical Research, Inc.

Houston, Texas, 77036, United States

Location

Centex Studies, Inc.

Houston, Texas, 77058, United States

Location

Memorial Pulmonology

Houston, Texas, 77079, United States

Location

BI Research Center

Houston, Texas, 77084, United States

Location

Clinical Investigations of Texas

Plano, Texas, 75075, United States

Location

ClinRX Research

Richardson, Texas, 75080, United States

Location

Quality Research, Inc.

San Antonio, Texas, 78209, United States

Location

Lee Medical Associates PA

San Antonio, Texas, 78213, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78213, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Panacea Clinical Research

San Antonio, Texas, 78228, United States

Location

Accurate Clinical Research Inc.

San Antonio, Texas, 78229, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Victorium Clinical Research

San Antonio, Texas, 78230, United States

Location

DCT-Stone Oak, LLC dba Discovery Clinical Trials

San Antonio, Texas, 78258, United States

Location

South Texas Radiology Imaging Centers

San Antonio, Texas, 78258, United States

Location

Envision Imaging

Southlake, Texas, 76092, United States

Location

Oakbend Medical Center

Sugar Land, Texas, 77479, United States

Location

ClinPoint Trials

Waxahachie, Texas, 75165, United States

Location

Mercury Clinical Research

Webester, Texas, 77598, United States

Location

Clinics of North Texas

Wichita Falls, Texas, 76302, United States

Location

Grayline Clinical Drug Trials

Wichita Falls, Texas, 76309, United States

Location

Granger Medical Clinic-Riverton

Riverton, Utah, 84065, United States

Location

Millennium Clinical Trials, LLC

Arlington, Virginia, 22207, United States

Location

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, 22911, United States

Location

Millennium Clinical Trials

Fairfax, Virginia, 22031, United States

Location

National Clinical Research-Norfolk, Inc.

Norfolk, Virginia, 23502, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Optimed Research, LTD

Bellingham, Washington, 98225, United States

Location

Swedish Medical Center Investigational Drug Services Pharmacy

Seattle, Washington, 98104, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98122, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Genesis Research Services

Broadmeadow, New South Wales, 2292, Australia

Location

Hunter Imaging Group

Cardiff, New South Wales, 2285, Australia

Location

Optimus Clinical Research Pty Ltd

Kogarah, New South Wales, 2217, Australia

Location

Southern Radiology

Miranda, New South Wales, 2228, Australia

Location

Royal Hospital for Women

Randwick, New South Wales, 2031, Australia

Location

Castlereagh Imaging

St Leonards, New South Wales, 2065, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Australian Clinical Research Network

Sydney, New South Wales, 2035, Australia

Location

Spectrum Medical Imaging

Sydney, New South Wales, 2035, Australia

Location

AusTrials Pty Ltd

Sherwood, Queensland, 4075, Australia

Location

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

Royal Adelaide Hospital Pharmacy

Adelaide, South Australia, 5000, Australia

Location

Bensons Radiology

North Adelaide, South Australia, 5006, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Capital Radiology-Malvern

Melbourne, Victoria, 3144, Australia

Location

Capital Radiology-Clayton

Melbourne, Victoria, 3168, Australia

Location

SKG Radiology Hollywood

Nedlands, Western Australia, 6009, Australia

Location

RK Will Pty Ltd

Victoria Park, Western Australia, 6100, Australia

Location

CMIP-Centro Mineiro de Pesquisa LTDA

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

CCBR - Centro de Pesquisas e Analises Clinicas LTDA

Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil

Location

CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda

São Paulo, São Paulo, 04266-010, Brazil

Location

Diagnostic Consultative Center "Sveti Georgi" EOOD

Plovdiv, 4000, Bulgaria

Location

Medical Center "Health for all" - EOOD

Plovdiv, 4000, Bulgaria

Location

UMHAT Kaspela - EOOD Rheumatology Clinic

Plovdiv, 4001, Bulgaria

Location

UMHAT Kaspela - EOOD

Plovdiv, 4001, Bulgaria

Location

"Medical Center Teodora" EOOD

Rousse, 7012, Bulgaria

Location

Diagnostic Consultative Center 17 Sofia EOOD

Sofia, 1505, Bulgaria

Location

UMHAT Sveti Ivan Rilski- EAD

Sofia, 1612, Bulgaria

Location

UMHAT "Sofiamed" OOD, Block 2

Sofia, 1750, Bulgaria

Location

"Medical Center- Dr. Hayvazov" EOOD

Sofia, 1784, Bulgaria

Location

Centro Integral de Reumatologia Reumalab S.A.S.

Medellín, Antioquia, 05001000, Colombia

Location

Centro de Investigacion en Reumatologia y Especialidades Medicas SAS CIREEM SAS

Bogotá, Bogota DC, 110221, Colombia

Location

Medicinski centar Kuna&Peric

Zagreb, 10000, Croatia

Location

National Hospital Organization Toyohashi Medical Center

Toyohashi, Aichi-ken, 440-8510, Japan

Location

Funabashi Municipal Medical Center

Funabashi, Chiba, 273-8588, Japan

Location

Matsudo City General Hospital

Matsudo, Chiba, 270-2296, Japan

Location

Kanbara Clinic

Kitakyushu, Fukuoka, 806-0026, Japan

Location

Hidaka Orthopedic Hospital

Kurume, Fukuoka, 830-0053, Japan

Location

Obase Hospital

Miyako-gun, Fukuoka, 800-0344, Japan

Location

Himeno Hospital

Yamegun, Fukuoka, 834-0115, Japan

Location

Ikeda Kinen Hospital

Sukagawa, Fukushima, 962-0001, Japan

Location

Zenshukai Hospital

Maebashi, Gunma, 379-2115, Japan

Location

Mazda Hospital

Aki-gun, Hiroshima, 735-8585, Japan

Location

Medical Corporation Okimoto Clinic

Kure, Hiroshima, 734-0304, Japan

Location

Medical Corporation Emu Emukai, Matterhorn Rehabilitation Hospital

Kure, Hiroshima, 737-0046, Japan

Location

Takahashi Orthopedics Clinic

Chitose, Hokkaido, 066-0062, Japan

Location

Obihiro Orthopaedic Hospital

Obihiro, Hokkaido, 080-0802, Japan

Location

Okubo Hospital

Akashi, Hyōgo, 674-0051, Japan

Location

Omuro Orthopedic Clinic

Himeji, Hyōgo, 670-0976, Japan

Location

Medical corporate corporation hoshikai Onishi medical clinic

Kako-gun, Hyōgo, 675-1115, Japan

Location

Kobe Red Cross Hospital

Kobe, Hyōgo, 651-0073, Japan

Location

Mito Saiseikai General Hospital

Mito, Ibaraki, 311-4198, Japan

Location

National Hospital Organization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Kokan Clinic

Kawasaki, Kanagawa, 210-0852, Japan

Location

Misugikai Medical Corporation Otokoyama Hospital

Yawata, Kyoto, 614-8366, Japan

Location

Nakajo Orthopedic Clinic

Sendai, Miyagi, 983-0862, Japan

Location

Marunouchi Hospital

Matsumoto, Nagano, 390-8601, Japan

Location

Oita University Hospital

Yufu, Oita Prefecture, 879-5593, Japan

Location

Sobajima Clinic/Orthopedics

Higashiosaka, Osaka, 577-0011, Japan

Location

Rinku General Medical Center

Izumisano, Osaka, 598-8577, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, 596-8522, Japan

Location

Social Welfare Organization Saiseikai Imperial Gift Foundation,Inc. Osaka Saiseikai Nakatsu Hospital

Osaka, Osaka, 530-0012, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Shimane University Hospital

Izumo, Shimane, 693-8501, Japan

Location

Fujieda Municipal General Hospital

Fujieda, Shizuoka, 426-8677, Japan

Location

JA Shizuoka Kohseiren Enshu Hospital

Hamamatsu, Shizuoka, 430-0929, Japan

Location

Japanese Red Cross Hamamatsu Hospital

Hamamatsu, Shizuoka, 434-8533, Japan

Location

Sonodakai Joint Replacement Center Hospital

Adachi-ku, Tokyo, 121-0064, Japan

Location

Medical Plaza Edogawa

Edogawa-ku, Tokyo, 133-0052, Japan

Location

Sato Orthopaedic Clinic

Edogawa-ku, Tokyo, 134-0084, Japan

Location

Fussa Hospital

Fussa, Tokyo, 197-8511, Japan

Location

Jukoukai hospital

Koto-ku, Tokyo, 136-0073, Japan

Location

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, 108-8642, Japan

Location

Tamagawa Hospital

Setagaya-ku, Tokyo, 158-0095, Japan

Location

Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital

Shinagawa-ku, Tokyo, 140-0001, Japan

Location

Ohimachi Orthopaedic Clinic

Shinagawa-ku, Tokyo, 140-0014, Japan

Location

Japan Organization of Occupational Health and Safety Sanin Rosai Hospital

Yonago, Tottori, 683-8605, Japan

Location

National Hospital Organization Chiba Medical Center

Chiba, 260-8606, Japan

Location

Chihaya Hospital

Fukuoka, 813-8501, Japan

Location

Kuroda Orthopedic Hospital

Fukuoka, 814-0165, Japan

Location

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, 730-8619, Japan

Location

Hiroshima Prefectural Hospital

Hiroshima, 734-8530, Japan

Location

Kumamoto Orthopaedic Hospital

Kumamoto, 862-0976, Japan

Location

Nagayoshi General Hospital

Osaka, 547-0016, Japan

Location

Iwasaki Orthopedic Surgery

Saitama, 330-0056, Japan

Location

Saitama Municipal Hospital

Saitama, 336-8522, Japan

Location

Saules seimos medicinos centras

Kaunas, LT-49449, Lithuania

Location

Klaipeda University Hospital

Klaipėda, LT-92288, Lithuania

Location

Republican Siauliai Hospital

Šiauliai, LT-76231, Lithuania

Location

Centro Hospitalario Mac, S.A. de C.V.

Guadajara, Jalisco, 45050, Mexico

Location

Consultorio Medico del Dr. Federico Galvan Villegas

Guadalajara, Jalisco, 45040, Mexico

Location

Lakeland Clinical Trials

Rotorua, BOP, 3010, New Zealand

Location

Otago Radiology

Dunedin, Otago, 9010, New Zealand

Location

RMC Medical Research Ltd

Dunedin, Otago, 9012, New Zealand

Location

South Pacific Clinical Trials

Auckland, 0610, New Zealand

Location

TRG Imaging Lincoln Road

Auckland, 0610, New Zealand

Location

Auckland Bone Density Ltd

Auckland, 0612, New Zealand

Location

North Shore Hospital, Waitemata District Health Board

Auckland, 0622, New Zealand

Location

Star Unit, North Shore Hospital, Waitemata District Health Board

Auckland, 0622, New Zealand

Location

The Radiology Group

Auckland, 0622, New Zealand

Location

Southern Clinical Trials- Waitemata Ltd

Auckland, 0626, New Zealand

Location

Auckland Bone Density

Auckland, 0632, New Zealand

Location

Optimal Clinical Trials

Auckland, 1010, New Zealand

Location

Auckland Radiology Parnell Branch

Auckland, 1052, New Zealand

Location

Southern Clinical Trials Ltd

Christchurch, 8013, New Zealand

Location

Collingwood Street Pharmacy

Nelson, 7010, New Zealand

Location

Nelson Radiology

Nelson, 7010, New Zealand

Location

Porter Rheumatology Ltd

Nelson, 7010, New Zealand

Location

Bay Radiology

Tauranga, 3110, New Zealand

Location

P3 Research Ltd

Tauranga, 3110, New Zealand

Location

Clinical Horizons NZ Ltd

Tauranga, 3112, New Zealand

Location

P3 Research Ltd

Wellington, 6021, New Zealand

Location

Pacific Radiology

Wellington, 6021, New Zealand

Location

Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios

Cayma, Arequipa, Peru

Location

Centro De Investigacion Clinica Trujillo EIRL/Clinica Peruano Americana S.A.

Trujillo, La Libertad, 13001, Peru

Location

ABK REUMA S.R.L. de Medicentro Biociencias/BIO CIENCIAS PERU S.R.L.

Lima, 21, Peru

Location

Centro de Investigación Reumatología CAA-Clinica Anglo Americana

Lima, 27, Peru

Location

Investigaciones en Reumatologia / Centro Medico Corpac S.A.

Lima, 27, Peru

Location

Centro de Investigaciones Medicas-Hospital Maria Auxiliadora

Lima, 29, Peru

Location

Investigaciones Clinicas S.A.C. / Instituto de Ginecologia y Reproduccion S.A.

Lima, 33, Peru

Location

Investigaciones Clinicas S.A.C./Instituto de Ginecologia y Reproduccion S.A.

Lima, 33, Peru

Location

Philippine General Hospital

Manila, NCR, 1000, Philippines

Location

Manila Doctors Hospital

Manila, 1000, Philippines

Location

Moscow Municipal Rheumatology Center

Moscow, 119049, Russia

Location

SBHI "City Clinical Hospital No. 1 n.a N.I. Pirogov"

Moscow, 119049, Russia

Location

SBHI "City Clinical Hospital No. 1 n.a. N.I. Pirogov"

Moscow, 119049, Russia

Location

Federal State Budgetary Scientific Research institution of fundamental and clinical immunology

Novosibirsk, 630047, Russia

Location

Federal State Budgetary Scientific Institution

Novosibirsk, 630117, Russia

Location

State Budgetary Institution of Ryazan Region

Ryazan, 390026, Russia

Location

Medical Technologies Ltd

Saint Petersburg, 191025, Russia

Location

Limited Liability Company "Medical Center "Reavita Med SPb"

Saint Petersburg, 194354, Russia

Location

Medinet LLC

Saint Petersburg, 194356, Russia

Location

FSBI 'SRITO n.a. R.R. Vreden' MoH RF

Saint Petersburg, 195427, Russia

Location

Institute for Rehabilitation

Belgrade, 11000, Serbia

Location

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

Institute for treatment and rehabilitation "Niska Banja"

Niška Banja, 18205, Serbia

Location

Special Hospital for Rheumatic Diseases Novi Sad

Novi Sad, 21000, Serbia

Location

General hospital "Dr Laza K. Lazarevic" Sabac

Šabac, 15000, Serbia

Location

Reumatologia s.r.o.

Bratislava, 820 07, Slovakia

Location

Nestatna Reumatologicka Ambulancia, Poliklinika Karlova Ves

Bratislava, 841 04, Slovakia

Location

MUDr. STRANAI s.r.o.

Košice, 040 11, Slovakia

Location

Reum.hapi s.r.o.

Nové Mesto nad Váhom, 91501, Slovakia

Location

MEDIPA s.r.o.

Piešťany, 921 01, Slovakia

Location

Thermium s.r.o.

Piešťany, 92101, Slovakia

Location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Department of Radiology

Daegu, 42472, South Korea

Location

Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Clinical Trial Center Pharmacy

Daejeon, 35015, South Korea

Location

Department of Radiology

Daejeon, 35015, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Department of Radiology

Gwangju, 61469, South Korea

Location

Pharmacy of Clinical Trial Center

Gwangju, 61469, South Korea

Location

Clinical Trial Pharmacy

Seoul, 02841, South Korea

Location

Department of Radiology

Seoul, 02841, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Clinical Trials Center Pharmacy

Seoul, 03080, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Clinical Trial Center Pharmacy

Seoul, 03722, South Korea

Location

Department of Radiology

Seoul, 03722, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Location

Clinical Research Pharmacy

Seoul, 05030, South Korea

Location

Department of Clinical Research Pharmacy, Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Department of Radiology

Seoul, 05030, South Korea

Location

Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Clinical Trial Center Pharmacy

Seoul, 06351, South Korea

Location

Department of Orthopedic Surgery, Samsung Medical Center

Seoul, 06351, South Korea

Location

Clinical Trial Pharmacy

Seoul, 06591, South Korea

Location

Department of Radiology

Seoul, 06591, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Clinical Research Pharmacy, SMG SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

Department of Clinical Research Pharmacy, SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

Department of Radiology

Seoul, 07061, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

Department of Radiology

Seoul, 07985, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

Location

Clinical Trial Pharmacy

Yangcheon-gu, Seoul, 07985, South Korea

Location

Changhua Christian Hospital Clinical Trial Pharmacy

Changhua, 500, Taiwan

Location

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Chang Gung Memorial Hospital-Kaohsiung Branch Clinical Trial Pharmacy

Kaohsiung City, 83301, Taiwan

Location

Chang Gung Memorial Hospital-Kaohsiung Branch

Kaohsiung City, 83301, Taiwan

Location

Chung Shan Medical University Hospital Clinical Trial Pharmacy

Taichung, 402, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Department of Pharmacy, China Medical University Hospital

Taichung, 40447, Taiwan

Location

Regional Communal Institution Chernivtsi Regional Clinical Hospital

Chernivtsi, 58001, Ukraine

Location

Communal Non-profit Institution "City Clinical Hospital No.27" of Kharkiv City Council

Kharkiv, 61002, Ukraine

Location

Government Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"

Kharkiv, 61039, Ukraine

Location

Chair of Internal Medicine #2

Kyiv, 01601, Ukraine

Location

Oleksandrivska Clinical Hospital Of Kyiv

Kyiv, 01601, Ukraine

Location

Kyiv City Clinical Hospital 3,Rheumatology Department

Kyiv, 02125, Ukraine

Location

Clinic of NI "NSC"M.D.Strazhesko Institute of Cardiology" of NAMS of Ukraine,

Kyiv, 03151, Ukraine

Location

Polyclinic of Administration of Medical Services and Rehabilitation of State Stock Holding Company

Kyiv, 04050, Ukraine

Location

Clinic of SI "Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine"

Kyiv, 04114, Ukraine

Location

Clinic of SI Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine

Kyiv, 04114, Ukraine

Location

National Medical University named after O O Bogomolets,

Kyiv, 04119, Ukraine

Location

Polyclinic Of Administration of Medical Services and Rehabilitation of SSHC Artem

Kyiv, 04119, Ukraine

Location

Communal Non-profit Institution "City Clinical Hospital #5 of Lviv", Therapeutics Department

Lviv, 79013, Ukraine

Location

Communal Institution "Odesa Regional Clinical Hospital"

Odesa, 65025, Ukraine

Location

Multi-field Medical Center (University Clinic No.1) of Odesa National Medical University,

Odesa, 65026, Ukraine

Location

Communal Institution Ternopil University Hospital

Ternopil, 46002, Ukraine

Location

Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov, Rheumatology Department,

Vinnytsia, 21018, Ukraine

Location

Communal Non-commercial Enterprise "Vinnytsia City Clinical Hospital No 1"

Vinnytsia, 21029, Ukraine

Location

Medical Clinical Investigational Centre of Medical Centre Health Clinic LTD

Vinnytsia, 21029, Ukraine

Location

Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Medical

Vinnytsia, 21029, Ukraine

Location

Vinnytsya Medical National University named after M.I. Pyrogov, Chair of Internal Medicine #3

Vinnytsia, 21029, Ukraine

Location

Communal Institution Zaporizhzhya Regional Clinical Hospital

Zaporizhzhya, 69600, Ukraine

Location

Related Publications (12)

  • 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.

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Related Links

MeSH Terms

Conditions

Chronic PainOsteoarthritis, HipOsteoarthritis, Knee

Interventions

Anti-Inflammatory Agents, Non-Steroidaltanezumab

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Limitations and Caveats

2 deaths occurred after end of study and are captured in All- cause mortality section.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer Inc.

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2015

First Posted

August 19, 2015

Study Start

July 21, 2015

Primary Completion

October 5, 2018

Study Completion

February 27, 2019

Last Updated

January 10, 2020

Results First Posted

January 10, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

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/data\_requests.

More information

Locations