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Osteoarthritis, KneePhase 3FACT OA1NCT03161093

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

A Phase 3 study testing Fasinumab and Naproxen in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Regeneron Pharmaceuticals at 139 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee, Osteoarthritis, Hip
What is being tested?
Fasinumab and Naproxen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,307 participants
Where
139 sitesin 12 countries
Study dates
17 Aug 2017to 27 Aug 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria include, but are not limited to, the following:

Year 1:

  1. Male and female patients, at least 18 years of age, at screening
  2. A clinical diagnosis of OA of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit
  3. Moderate to severe pain in the index joint defined at both the screening and randomization visits
  4. Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (acetaminophen/paracetamol) to be taken as needed with a maximum daily dose of 2500 mg (countries where 500 mg strength tablets/capsules are available) or 2600 mg (countries where 325 mg strength tablets/capsules are available)
  5. A history of at least 12 weeks of analgesics use for pain due to OA of the knee or hip, as defined by:
  6. Inadequate pain relief from acetaminophen/paracetamol AND
  7. Intolerance to or inadequate pain relief from opioid or tramadol therapy, unwillingness to take opioid or tramadol therapy for a medically acceptable reason, or lack of access to an opioid or to tramadol
  8. Currently using a stable dose of NSAID.
  9. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the initial 16 weeks of treatment
  10. Stable treatment with glucosamine sulfate and chondroitin sulfate treatments must be stopped during the pre-randomization period
  11. Consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere prior to and during the study period to be shared with the investigator
  12. Willing to maintain current activity and exercise levels throughout the study
  13. Willing and able to comply with clinic visits and study-related procedures and willing to provide follow-up information related to any JR surgery that occurs within the period of time covered by their intended participation in the study
  14. Able to understand and complete study-related questionnaires

Year 2:

Note: Any Year 1 patient attending their week 52 visit on or after 26 March 2020 will no longer have the option to enroll into Year 2.

  1. Completed the treatment period of Year 1
  2. Did not permanently discontinue study drug during Year 1
  3. Received no less than 10 of the 13 planned doses of SC study drug during the treatment period of Year 1
  4. Provide informed consent for Year 2
  5. Willing to continue to maintain current activity and exercise levels throughout Year 2

Exclusion Criteria include, but are not limited to, the following:

  1. Non-compliance with the Numeric Rating Scale (NRS) recording during the pre-randomization period
  2. History or presence at the screening visit of non-OA inflammatory joint disease, Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
  3. History or presence on imaging of arthropathy, neuropathic joint arthropathy, hip or knee dislocation, extensive subchondral cysts, significant bone collapse or bone loss, or pathologic fractures
  4. Trauma to the index joint within 3 months prior to the screening visit
  5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
  6. Patient is not a candidate for MRI
  7. Is scheduled for a JR surgery to be performed during the study period or who would be unwilling or unable to undergo JR surgery if needed
  8. History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
  9. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
  10. History of naproxen intolerance, or existence of a medical condition that is high risk for naproxen-associated complications
  11. Resting heart rate of <50 beats per minute (bpm) or >100 bpm at the screening or randomization visits
  12. History or presence of 2nd or 3rd degree heart block, 1st degree heart block with abnormal Complex of Q, R, and S waves on an electrocardiogram (QRS) complex, or bifascicular block by ECG assessment at the screening visit
  13. History or presence of orthostatic hypotension at the screening, prerandomization, or randomization visits
  14. History of poorly controlled hypertension
  15. Use of systemic corticosteroid within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit
  16. Exposure to an anti-Nerve growth factor (NGF) antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies

Trial locations and contacts

139 sites in 12 countries.

139 sites in 12 countries

United States58 sites

  • Lovelace Scientific Resources, Inc.

    Albuquerque, New Mexico, 87108

  • Lynn Institute of Denver

    Aurora, Colorado, 80012

  • Arthritis and Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia, 25801

  • United Medical Associates

    Binghamton, New York, 13901

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

    Cary, North Carolina, 27518

  • Low Country Rheumatology, PA

    Charleston, South Carolina, 29406

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210

  • Center for Arthritis and Rheumatic Diseases

    Chesapeake, Virginia, 23320

  • Medex Healthcare Research, Inc.

    Chicago, Illinois, 60602

  • Northwestern University

    Chicago, Illinois, 60611

  • Sterling Research Group, Ltd.

    Cincinnati, Ohio, 45219

  • Lynn Institute of the Rockies

    Colorado Springs, Colorado, 80920

  • Medvin Clinical Research

    Covina, California, 91722

  • Klein & Associates, MD PA

    Cumberland, Maryland, 21502

  • Pioneer Research Solutions, Inc.

    Cypress, Texas, 77429

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • TriWest Research Associates, LLC

    El Cajon, California, 92020

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60422

  • Clinical Research Solutions

    Franklin, Tennessee, 37067

  • Panorama Orthopedics & Spine Center

    Golden, Colorado, 80401

  • Klein & Associates, MD, PA

    Hagerstown, Maryland, 21740

  • Hickory Family Practice Associates

    Hickory, North Carolina, 28601

  • Peters Medical Research LLC

    High Point, North Carolina, 27262

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • PMG Research of Knoxville

    Knoxville, Tennessee, 37912

  • BioSolutions Clinical Research

    La Mesa, California, 91942

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska, 68516

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • Pacific Arthritis Care Center

    Los Angeles, California, 90045

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Arizona Arthritis & Rheumatology Research, PLLC

    Mesa, Arizona, 85210

  • Southwest Rheumatology Research, LLC

    Mesquite, Texas, 75150

  • PMG Research of Charleston, LLC

    Mt. Pleasant, South Carolina, 29464

  • Medex Healthcare Research

    New York, New York, 10036

  • Sensible Healthcare

    Ocoee, Florida, 34761

  • Hillcrest Clinical Research

    Oklahoma City, Oklahoma, 73119

  • Buffalo Rheumatology and Medicine, PLLC

    Orchard Park, New York, 14127

  • Orchard Park Family Practice

    Orchard Park, New York, 14127

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Jewett Orthopaedic Clinic

    Orlando, Florida, 32825

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • PMG Research of Salisbury, LLC

    Salisbury, North Carolina, 28144

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Artemis Clinical Research

    San Marcos, California, 92078

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Medex Healthcare Research, Inc.

    St Louis, Missouri, 63117

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Tucson Orthopaedic Research Center

    Tucson, Arizona, 85712

  • Lovelace Scientific Resources

    Venice, Florida, 34292

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01605

Other trials in United States

South Africa19 sites

  • TASK Applied Science

    Cape Town, 7530

  • Mzansi Ethical Research Centre Cape Town

    Cape Town, 7764

  • Synapta Clinical Research Center

    Durban, KwaZulu-Natal, 4001

  • Enhancing Care

    Durban, KwaZulu-Natal, 4091

  • Aliwal Shoal Medical Centre

    eMkhomazi, KwaZulu-Natal, 4170

  • Wits Clinical Research

    Johannesburg, Gauteng, 2013

  • Newtown Clinical Research

    Johannesburg, 2113

  • Langeberg Medicross Medical Centre

    Kraaifontein, Western Cape, 7570

  • Mzansi Ethical Research Centre Middleburg

    Middelburg, Mpumalanga, 1055

  • Paarl Research Centre

    Paarl, Western Cape, 7646

  • Tread Research-Tygerberg Hospital

    Parow, Cape Town, 7500

  • University of Pretoria

    Pretoria, Gauteng, 0002

  • Global Clinical Trials

    Pretoria, Gauteng, 0083

  • Synexus SA Stanza Clinical Research Centre

    Pretoria, Gauteng, 0122

  • Synexus Watermeyer Clinical Research Centre

    Pretoria, Gauteng, 0184

  • Roodepoort Medicross Clinical Research Centre

    Roodepoort, Gauteng, 1724

  • Synexus Helderberg Clinical Trial Centre

    Somerset West, Western Cape, 7130

  • Soweto Clinical Trials Centre (CTC)

    Soweto, Johannesburg, 1818

  • Welkom Clinical trial Centre

    Welkom, Free State, 9460

Other trials in South Africa

Poland14 sites

  • ClinicMed Daniluk, Nowak Sp.j.

    Bialystok, 15-879

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdynia, Pomeranian Voivodeship, 81-537

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, Pomeranian Voivodeship, 81-537

  • MCBK Sc lwona Czajkowska Monika Barney

    Grodzisk Mazowiecki, Masovian Voivodeship, 05-825

  • Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, 40-040

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, Lesser Poland Voivodeship, 31-501

  • Malopolskie Centrum Kliniczne

    Krakow, 30-149

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

    Lodz, Łódź Voivodeship, 90-368

  • Synexus Polska Sp. z o.o Oddzial w Poznaniu

    Poznan, Greater Poland Voivodeship, 60-702

  • CLINMEDICA RESEARCH OMC, Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa

    Skierniewice, 96-100

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, Masovian Voivodeship, 01-192

  • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o.

    Warsaw, Masovian Voivodeship, 04-730

  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroclaw, Lower Silesian Voivodeship, 59-381

  • Etg Zgierz

    Zgierz, 95-100

Other trials in Poland

United Kingdom12 sites

  • Synexus Midlands Clinical Research Centre

    Birmingham, West Midlands, B15 2SQ

  • Synexus Wales Clinical Research Centre

    Cardiff, CF15 9SS

  • Synexus Lancashire Clinical Research Centre

    Chorley, Lancashire, PR7 7NA

  • Synexus Scotland Clinical Research Centre

    Glasgow, Lanarkshire, G20 0SP

  • Synexus North East Clinical Research Centre - Hexham General Hospital

    Hexham, Northumberland, NE46 1QJ

  • Synexus Merseyside Clinical Research Centre

    Liverpool, L22 0LG

  • Synexus Manchester Clinical Research Centre-Manchester Science Park

    Manchester, M15 6SX

  • MediNova North London Dedicated Research Centre, Mount Vernon Hospital

    Northwood, Middlesex, HA6 2RN

  • Synexus Thames Valley Clinical Research Centre

    Reading, Berkshire, RG2 0TG

  • Medinova Research East London Clinical Studies Centre

    Romford, RM1 3PJ

  • MeDiNova Research Yorkshire Clinical Studies Centre

    Shipley, BD18 3SA

  • MediNova South London Dedicated Research Centre

    Sidcup, DA14 6LT

Other trials in United Kingdom

Hungary8 sites

  • Qualiclinic Kft.

    Budapest, 1036

  • Synexus Magyarorszag Kft

    Budapest, 1036

  • Synexus Magyarorszag Kft.

    Debrecen, 4025

  • Synexus Magyarorszag Kft.

    Gyula, 5700

  • BKS Research Kft.

    Hatvan, 3000

  • Hevizgyogyfurdo es Szent Andraes ReumaKorhaz

    Hévíz, 8380

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

    Nyíregyháza, 4400

  • Synexus Magyarorszag Egeszsegugyi Kft.

    Zalaegerszeg, 8900

Other trials in Hungary

Spain6 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • CETA Leganes

    Leganés, Madrid, 28915

  • MeDiNova Investigacion y Desarrollo

    Madrid, 28100

  • Centro De Investigacion Clinica En Enfermedades Cronicas - Cicec

    Santiago de Compostela, 15705

  • Clínica Nuevas Tecnologias en Diabetes y Endocrinologia (NTDE)

    Seville, 41003

  • Hospital Quiron Salud Infanta Luisa

    Seville, 41010

Other trials in Spain

Ukraine6 sites

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

    Cherkasy, 18009

  • Kharkiv City Multispecialty Hospital #18

    Kharkiv, 61029

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

    Kyiv, 02002

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

    Kyiv, 03037

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

    Kyiv, 03049

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

    Lviv, 79495

Other trials in Ukraine

Russia5 sites

  • "SBEIHPE ""Kazan State Medical University"" of MHSD of Russia"

    Kazan', Tatarstan Republic, 420012

  • "CDCR ""Healthy Joints"" L.L.C."

    Novosibirsk, 630099

  • City Out-Patient Clinic #109

    Saint Petersburg, 192263

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

    Samara, 443095

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

    Yaroslavl, 150007

Other trials in Russia

Germany4 sites

  • Synexus Clinical Research GmbH

    Berlin, 12627

  • Synexus Clinical Research GmbH

    Bochum, 44787

  • Synexus Clinical Research GmbH

    Frankfurt, 60313

  • Synexus Clinical Research GmbH

    Leipzig, Saxony, 04103

Other trials in Germany

Lithuania4 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT35144

  • Saules Seimos Medicinos Centras, Jsc

    Kaunas, LT50009

  • Republican Panevezys Hospital

    Panevezys, LT01117

  • Center Outpation Clinic, Public Institution

    Vilnius, LT01117

Other trials in Lithuania

Romania2 sites

  • Clinica Medicala Synexus Ltd.

    Bucharest, 021611

  • SC Policlinica CCBR SRL

    Bucharest, 030463

Other trials in Romania

Denmark1 site

  • CCBR Vejle

    Vejle, DK 7100

Other trials in Denmark

About this study

Official title: A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip

The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.

The secondary objectives of the study are:

  1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
  2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
  3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
  4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip
  5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip
  6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
  7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
  8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
  9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
  10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
Being tested
Fasinumab, Naproxen, Fasinumab-matching placebo, Naproxen-matching placebo
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FasinumabDrug

    Also called REGN475

    Solution for injection in pre-filled syringe

  • NaproxenDrug

    Pharmaceutical form: Capsule

  • Fasinumab-matching placeboDrug

    Solution for injection in pre-filled syringe

  • Naproxen-matching placeboDrug

    Capsule

Study groups in NCT03161093
Study groupRoleWhat they receive
Fasinumab dosing regimen 1ExperimentalFasinumab Subcutaneous (SC) dosing regimen 1 and naproxen-matching placebo oral
Receives: Drug: Fasinumab; Drug: Naproxen-matching placebo
Fasinumab dosing regimen 2ExperimentalFasinumab SC dosing regimen 2 and naproxen-matching placebo oral
Receives: Drug: Fasinumab; Drug: Naproxen-matching placebo
Fasinumab-matching placebo and naproxenExperimentalNot described
Receives: Drug: Naproxen; Drug: Fasinumab-matching placebo
Fasinumab-matching placebo and naproxen-matching placeboExperimentalNot described
Receives: Drug: Fasinumab-matching placebo; Drug: Naproxen-matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 16

  2. Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 16

  3. Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 16

  4. Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 16

Secondary outcomes (45)

  1. Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo

    The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).

    Measured: Baseline to Week 16

  2. Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen

    The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).

    Measured: Baseline to Week 16

  3. Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo

    The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).

    Measured: Baseline to Week 44

  4. Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 16

  5. Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Week 16

  6. Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 16

  7. Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 44

  8. Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 44

  9. Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to average score across weeks 4, 8, 12 and 16

  10. Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to average score across weeks 36, 40 and 44

  11. Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 16

  12. Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 44

  13. Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 44

  14. Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to average score across weeks 4, 8, 12 and 16

  15. Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to average score across weeks 36, 40 and 44

  16. Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo

    The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).

    Measured: Baseline to Week 16

  17. Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen

    The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).

    Measured: Baseline to Week 16

  18. Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo

    The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).

    Measured: Baseline to Week 44

  19. Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 16

  20. Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 44

  21. Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to average score across weeks 4, 8, 12 and 16

  22. Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to average score across weeks 36, 40 and 44

  23. Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 16

  24. Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 44

  25. Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to average score across weeks 4, 8, 12 and 16

  26. Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to Week 16

  27. Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Measured: Baseline to average score across weeks 36, 40 and 44

  28. Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1

    Measured: Baseline to Week 52

  29. Number of Participants With AA (as Confirmed by Adjudication) - Year 2

    Measured: First dose of study drug in Year 2 through week 104E

  30. Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2

    Measured: Day 1 through week 104E (Extension)

  31. Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1

    Measured: Baseline to Week 52

  32. Number of Participants With DA (as Confirmed by Adjudication) - Year 2

    Measured: First dose of study drug in Year 2 through week 104E

  33. Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2

    Measured: Day 1 through week 104E

  34. Number of Treatment Emergent Adverse Events (TEAEs) - Year 1

    Measured: Baseline to Week 52

  35. Number of TEAEs - Year 2

    Measured: First dose of study drug in Year 2 through week 104E

  36. Number of TEAEs - Year 1 and Year 2

    Measured: Day 1 through week 104E

  37. Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1

    Measured: Baseline to Week 52

  38. Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2

    Measured: First dose of study drug in Year 2 through week 104E

  39. Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2

    Measured: Day 1 through week 104E

  40. Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1

    Measured: Baseline to Week 52

  41. Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2

    Measured: First dose of study drug in Year 2 through week 104E

  42. Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2

    Measured: Day 1 through week 104E

  43. Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1

    Measured: Baseline to Week 52

  44. Number of Participants With Any Type of All-Cause JR in Year 2

    Measured: First dose of study drug in Year 2 through week 104E

  45. Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2

    Measured: Day 1 through week 104E

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2017
  2. Study start17 Aug 2017
  3. Primary completion9 Sep 2019
  4. Study completion27 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
3,307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03161093
Sponsor's protocol ID
R475-OA-1611
Other IDs
2016-005020-29, 2016
Acronym
FACT OA1
Status last verified
Oct 2022
First submitted
18 May 2017
Last updated
14 Nov 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • DiMartino SJ, Cicirello H, Magyar A, Eng S, Ho T, Manvelian G, Patel Y, Pervin K, Trinh N, Fetell M, Braunstein N, Geba GP, Dakin P. A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip. RMD Open. 2026 Jan 16;12(1):e006436. doi: 10.1136/rmdopen-2025-006436.

    PubMed 41545313

  • DiMartino SJ, Gao H, Neogi T, Fuerst T, Zaim S, Eng S, Ho T, Manvelian G, Braunstein N, Geba GP, Dakin P. Prevalence of preexisting articular bone pathology in patients with osteoarthritis screened for fasinumab clinical trials identified by X-ray or magnetic resonance imaging. Osteoarthritis Cartilage. 2024 Dec;32(12):1601-1609. doi: 10.1016/j.joca.2024.07.001. Epub 2024 Jul 14.

    PubMed 39004211

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fasinumab and Naproxen in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Regeneron Pharmaceuticals at 139 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, South Africa, Poland, United Kingdom, Hungary and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo (time frame: Baseline to Week 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03161093, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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