Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

Last updated: January 30, 2023
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Osteoarthritis

Treatment

N/A

Clinical Study ID

NCT03304379
R475-OA-1688
2017-001702-15
  • Ages > 18
  • All Genders

Study Summary

The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.

The secondary objectives of the study are:

  • To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip

  • To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip

Eligibility Criteria

Inclusion

Key Inclusion Criteria (additional criteria may apply at screening):

  1. A clinical diagnosis of osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit.

  2. 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])

  3. A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics used for pain due to OA of the knee or hip

  4. Currently using a stable dose of NSAID

  5. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the 24 weeks of treatment

Key Exclusion Criteria (additional criteria may apply at screening):

  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, hip or knee dislocation, extensive subchondral cysts, evidence of severe structural damage, bone collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures

  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 magnetic resonance imaging (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. Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs)

  10. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy

  11. Use of systemic corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit

  12. Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies

  13. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the start of the first treatment, during the study, and for at least 20 weeks after the last dose

Study Design

Total Participants: 1650
Study Start date:
October 26, 2017
Estimated Completion Date:
November 09, 2020

Connect with a study center

  • Pinnacle Research Group, Llc

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Horizon Research Partners

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Clinical Research Advantage, Inc./Warner Family Practice, PC

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Synexus Central Phoenix Medical Clinic

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Clinical Research Consortium Arizona

    Tempe, Arizona 85283
    United States

    Site Not Available

  • Advance Research Center

    Anaheim, California 92805
    United States

    Site Not Available

  • TriWest Research Associates, LLC

    El Cajon, California 92020
    United States

    Site Not Available

  • Paragon Rx Clinical Research, Inc.

    Garden Grove, California 92840
    United States

    Site Not Available

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Site Not Available

  • Sierra Clinical Research

    Roseville, California 95661
    United States

    Site Not Available

  • UC Davis Center for Musculoskeletal Health

    Sacramento, California 95817
    United States

    Site Not Available

  • Advanced Research Center, Inc

    San Diego, California 92103
    United States

    Site Not Available

  • California Research Foundation

    San Diego, California 92123
    United States

    Site Not Available

  • Paragon Rx Clinical Research, Inc

    Santa Ana, California 92703
    United States

    Site Not Available

  • Encompass Clinical Research

    Spring Valley, California 91978
    United States

    Site Not Available

  • Westlake Medical Research

    Thousand Oaks, California 91360
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Vista, California 92083
    United States

    Site Not Available

  • Mountain View Clinical Research

    Denver, Colorado 80209
    United States

    Site Not Available

  • New England Research Associates, LLC

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • CRM of Greater New Haven, LLC

    Hamden, Connecticut 06157
    United States

    Site Not Available

  • Stamford Therapeutics Consortium

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Avail Clinical Research, LLC

    DeLand, Florida 32720
    United States

    Site Not Available

  • AMB Research Center, Inc

    Miami, Florida 33144
    United States

    Site Not Available

  • Allied Biomedical Research Institute

    Miami, Florida 33155
    United States

    Site Not Available

  • Lakes Research, LLC

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Bioclinica Research

    Orlando, Florida 32806
    United States

    Site Not Available

  • Gulf Region Clinical Research institute

    Pensacola, Florida 32514
    United States

    Site Not Available

  • Integral Rheumatology & Immunology Specialists (IRIS)

    Plantation, Florida 33324
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Drug Studies America

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Georgia Institute For Clinical Research LLC

    Marietta, Georgia 30060
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Chicago Clinical Research Institute, Inc

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Affinity Clinical Research Institute

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Clinical Research Advantage, Inc.

    Evansville, Indiana 47714
    United States

    Site Not Available

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana 47714
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Tufts Medical Center, Inc.

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Onyx Clinical Research

    Caro, Michigan 48723
    United States

    Site Not Available

  • Radiant Research, Inc.

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Richfield, Minnesota 55423
    United States

    Site Not Available

  • Skyline Medical Center /Radiant Research, Inc.

    Elkhorn, Nebraska 68022
    United States

    Site Not Available

  • Meridian Clinical Research Associates, LLC

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Robert Kaplan, D.O.

    Las Vegas, Nevada 89144
    United States

    Site Not Available

  • Amici Clinical Research, LLC

    Raritan, New Jersey 08869
    United States

    Site Not Available

  • Amici Clinical Research, LLC

    Warren, New Jersey 07059
    United States

    Site Not Available

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Drug Trial Brooklyn

    Brooklyn, New York 11230
    United States

    Site Not Available

  • Northwell Health

    Great Neck, New York 11021
    United States

    Site Not Available

  • Drug Trials America

    Hartsdale, New York 10530
    United States

    Site Not Available

  • Upstate Clinical Research Associates, LLC

    Williamsville, New York 14221
    United States

    Site Not Available

  • Carolina Research Center

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • PMG Research of Wilmington LLC

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • The Center For Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • New Horizons Clinical Research

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Aventiv Research Inc

    Columbus, Ohio 43213
    United States

    Site Not Available

  • DOC Clinical Research

    Dayton, Ohio 45432
    United States

    Site Not Available

  • Center for Orthopaedics and Sports Medicine

    Indiana, Pennsylvania 15701
    United States

    Site Not Available

  • Radiant Research, Inc.

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Piedmont Comprehensive Pain Management Group

    Greenville, South Carolina 29601
    United States

    Site Not Available

  • Radiant Research, Inc.

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Piedmont Research Partners, LLC

    Indian Land, South Carolina 29707
    United States

    Site Not Available

  • Coastal Carolina Research Center at LowCountry Orthopaedics

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • ACME Research, LLC

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Office of Dr.Ramesh C. Gupta MD

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • West Texas Clinical Research

    Lubbock, Texas 79410
    United States

    Site Not Available

  • Clinical Investigations Of Texas

    Plano, Texas 75075
    United States

    Site Not Available

  • Synexus USA

    Plano, Texas 75093
    United States

    Site Not Available

  • Charlottesville Medical Research Center LLC

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Health Research of Hampton Roads, Inc

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Spokane Joint Replacement Center

    Spokane, Washington 99218
    United States

    Site Not Available

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