A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

PHASE3CompletedINTERVENTIONAL
Enrollment

3,307

Participants

Timeline

Start Date

August 17, 2017

Primary Completion Date

September 9, 2019

Study Completion Date

August 27, 2021

Conditions
Osteoarthritis, KneeOsteoarthritis, Hip
Interventions
DRUG

Fasinumab

Solution for injection in pre-filled syringe

DRUG

Naproxen

Pharmaceutical form: Capsule

DRUG

Fasinumab-matching placebo

Solution for injection in pre-filled syringe

DRUG

Naproxen-matching placebo

Capsule

Trial Locations (139)

1036

Qualiclinic Kft., Budapest

Synexus Magyarorszag Kft, Budapest

1055

Mzansi Ethical Research Centre Middleburg, Middelburg

1724

Roodepoort Medicross Clinical Research Centre, Roodepoort

1818

Soweto Clinical Trials Centre (CTC), Soweto

2013

Wits Clinical Research, Johannesburg

2113

Newtown Clinical Research, Johannesburg

3000

BKS Research Kft., Hatvan

4001

Synapta Clinical Research Center, Durban

4025

Synexus Magyarorszag Kft., Debrecen

4091

Enhancing Care, Durban

4170

Aliwal Shoal Medical Centre, eMkhomazi

4400

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak Josa Andras Oktatokorhaza Klinikai Kutatasi Osztaly, Nyíregyháza

5700

Synexus Magyarorszag Kft., Gyula

7130

Synexus Helderberg Clinical Trial Centre, Somerset West

7500

Tread Research-Tygerberg Hospital, Parow

7530

TASK Applied Science, Cape Town

7570

Langeberg Medicross Medical Centre, Kraaifontein

7646

Paarl Research Centre, Paarl

7764

Mzansi Ethical Research Centre Cape Town, Cape Town

8380

Hevizgyogyfurdo es Szent Andraes ReumaKorhaz, Hévíz

8900

Synexus Magyarorszag Egeszsegugyi Kft., Zalaegerszeg

9460

Welkom Clinical trial Centre, Welkom

10036

Medex Healthcare Research, New York

12627

Synexus Clinical Research GmbH, Berlin

13760

Regional Clinical Research, Inc., Endwell

13901

United Medical Associates, Binghamton

14127

Buffalo Rheumatology and Medicine, PLLC, Orchard Park

Orchard Park Family Practice, Orchard Park

15006

Complejo Hospitalario Universitario A Coruna, A Coruña

15705

Centro De Investigacion Clinica En Enfermedades Cronicas - Cicec, Santiago de Compostela

16635

Altoona Center for Clinical Research, Duncansville

18009

"Municipal Establishment Cherkasy Regional Hospital of Cherkasy Oblast Council", Cherkasy

20902

The Center for Rheumatology and Bone Research, Wheaton

21502

Klein & Associates, MD PA, Cumberland

21740

Klein & Associates, MD, PA, Hagerstown

23320

Center for Arthritis and Rheumatic Diseases, Chesapeake

25801

Rheumatology & Pulmonary Clinic, Beckley

27103

PMG Research of Winston-Salem, LLC, Winston-Salem

27262

Peters Medical Research LLC, High Point

27518

PMG Research of Raleigh, LLC d/b/a PMG Research of Cary, Cary

28100

MeDiNova Investigacion y Desarrollo, Madrid

28144

PMG Research of Salisbury, LLC, Salisbury

28210

DJL Clinical Research, PLLC, Charlotte

28601

Hickory Family Practice Associates, Hickory

28915

CETA Leganes, Leganés

29406

Low Country Rheumatology, PA, Charleston

29464

PMG Research of Charleston, LLC, Mt. Pleasant

31406

Meridian Clinical Research, Savannah

32216

Jacksonville Center for Clinical Research, Jacksonville

32256

Clinical Neuroscience Solutions, Inc., Jacksonville

32801

Clinical Neuroscience Solutions, Inc., Orlando

32825

Jewett Orthopaedic Clinic, Orlando

33180

Arthritis and Rheumatic Disease Specialties, Aventura

34292

Lovelace Scientific Resources, Venice

34761

Sensible Healthcare, Ocoee

37067

Clinical Research Solutions, Franklin

37912

PMG Research of Knoxville, Knoxville

38119

Clinical Neuroscience Solutions, Inc., Memphis

41003

Clínica Nuevas Tecnologias en Diabetes y Endocrinologia (NTDE), Seville

41010

Hospital Quiron Salud Infanta Luisa, Seville

44787

Synexus Clinical Research GmbH, Bochum

45219

Sterling Research Group, Ltd., Cincinnati

50265

Integrated Clinical Trial Services, Inc., West Des Moines

60313

Synexus Clinical Research GmbH, Frankfurt

60422

Healthcare Research Network II, LLC, Flossmoor

60602

Medex Healthcare Research, Inc., Chicago

60611

Northwestern University, Chicago

61029

Kharkiv City Multispecialty Hospital #18, Kharkiv

63117

Medex Healthcare Research, Inc., St Louis

63141

Sundance Clinical Research, LLC, St Louis

64114

The Center for Pharmaceutical Research, Kansas City

68516

Physician Research Collaboration, LLC, Lincoln

72205

Baptist Health Center for Clinical Research, Little Rock

73119

Hillcrest Clinical Research, Oklahoma City

75150

Southwest Rheumatology Research, LLC, Mesquite

77429

Pioneer Research Solutions, Inc., Cypress

79495

Lviv Regional Hospital for veterans of the war and former political prisoners, Lviv

80012

Lynn Institute of Denver, Aurora

80401

Panorama Orthopedics & Spine Center, Golden

80920

Lynn Institute of the Rockies, Colorado Springs

83642

Advanced Clinical Research, Meridian

85053

Arizona Research Center, Phoenix

85210

Arizona Arthritis & Rheumatology Research, PLLC, Mesa

85712

Tucson Orthopaedic Research Center, Tucson

87108

Lovelace Scientific Resources, Inc., Albuquerque

90045

Pacific Arthritis Care Center, Los Angeles

91722

Medvin Clinical Research, Covina

91942

BioSolutions Clinical Research, La Mesa

92020

TriWest Research Associates, LLC, El Cajon

92078

Artemis Clinical Research, San Marcos

92103

Artemis Institute for Clinical Research, San Diego

150007

"State Autonomous Healthcare Institution of Yaroslavl Oblast Clinical Hospital #3", Yaroslavl

192263

City Out-Patient Clinic #109, Saint Petersburg

420012

"SBEIHPE Kazan State Medical University of MHSD of Russia", Kazan'

443095

Samara Regional Clinical Hospital n.a.V.D.Seredavin, Samara

630099

"CDCR Healthy Joints L.L.C.", Novosibirsk

01605

Clinical Pharmacology Study Group, Worcester

DK 7100

CCBR Vejle, Vejle

04103

Synexus Clinical Research GmbH, Leipzig

LT35144

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

LT50009

Saules Seimos Medicinos Centras, Jsc, Kaunas

LT01117

Republican Panevezys Hospital, Panevezys

Center Outpation Clinic, Public Institution, Vilnius

60-702

Synexus Polska Sp. z o.o Oddzial w Poznaniu, Poznan

31-501

Krakowskie Centrum Medyczne Sp. z o.o., Krakow

59-381

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw

05-825

MCBK Sc lwona Czajkowska Monika Barney, Grodzisk Mazowiecki

01-192

Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warsaw

04-730

Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o., Warsaw

81-537

Synexus Polska Sp. z o.o. Oddzial w Gdansku, Gdynia

Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia

15-879

ClinicMed Daniluk, Nowak Sp.j., Bialystok

40-040

Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice

30-149

Malopolskie Centrum Kliniczne, Krakow

96-100

CLINMEDICA RESEARCH OMC, Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa, Skierniewice

95-100

Etg Zgierz, Zgierz

90-368

Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Jednostka 02 - SOMED - Lodzkie Centrum Osteoporozy, Lodz

021611

Clinica Medicala Synexus Ltd., Bucharest

030463

SC Policlinica CCBR SRL, Bucharest

0002

University of Pretoria, Pretoria

0083

Global Clinical Trials, Pretoria

0122

Synexus SA Stanza Clinical Research Centre, Pretoria

0184

Synexus Watermeyer Clinical Research Centre, Pretoria

02002

Medical center of Private High Educational Institute Institute of General Practice-Family Medicine, Kyiv

03037

"Subsidiary Company Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud", Kyiv

03049

"Kyiv Railway Clinical Hospital No.2 of branch Health Center of the PJSC Ukrainian Railway", Kyiv

RG2 0TG

Synexus Thames Valley Clinical Research Centre, Reading

G20 0SP

Synexus Scotland Clinical Research Centre, Glasgow

PR7 7NA

Synexus Lancashire Clinical Research Centre, Chorley

HA6 2RN

MediNova North London Dedicated Research Centre, Mount Vernon Hospital, Northwood

NE46 1QJ

Synexus North East Clinical Research Centre - Hexham General Hospital, Hexham

B15 2SQ

Synexus Midlands Clinical Research Centre, Birmingham

CF15 9SS

Synexus Wales Clinical Research Centre, Cardiff

L22 0LG

Synexus Merseyside Clinical Research Centre, Liverpool

M15 6SX

Synexus Manchester Clinical Research Centre-Manchester Science Park, Manchester

RM1 3PJ

Medinova Research East London Clinical Studies Centre, Romford

BD18 3SA

MeDiNova Research Yorkshire Clinical Studies Centre, Shipley

DA14 6LT

MediNova South London Dedicated Research Centre, Sidcup

All Listed Sponsors
collaborator

Teva Pharmaceutical Industries, Ltd.

INDUSTRY

lead

Regeneron Pharmaceuticals

INDUSTRY

NCT03161093 - A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip | Biotech Hunter | Biotech Hunter