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Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip

24. marts 2017 opdateret af: Regeneron Pharmaceuticals

A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip

The primary objective of this study is to evaluate the effectiveness of REGN475 compared to placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history of inadequate joint pain relief or intolerance to current analgesic therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

421

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
      • Mobile, Alabama, Forenede Stater
    • Arizona
      • Chandler, Arizona, Forenede Stater
      • Phoenix, Arizona, Forenede Stater
      • Tuscon, Arizona, Forenede Stater
    • Arkansas
      • Hot Spring, Arkansas, Forenede Stater
      • Little Rock, Arkansas, Forenede Stater
    • California
      • Anaheim, California, Forenede Stater
      • Beverly Hills, California, Forenede Stater
      • El Cajon, California, Forenede Stater
      • Sacramento, California, Forenede Stater
      • San Diego, California, Forenede Stater
      • Santa Ana, California, Forenede Stater
      • Thousand Oaks, California, Forenede Stater
      • Upland, California, Forenede Stater
      • Walnut Creek, California, Forenede Stater
    • Colorado
      • Lakewood, Colorado, Forenede Stater
    • Florida
      • Clearwater, Florida, Forenede Stater
      • Fleming Island, Florida, Forenede Stater
      • Jacksonville, Florida, Forenede Stater
      • Miami, Florida, Forenede Stater
      • Orlando, Florida, Forenede Stater
      • Palm Harbor, Florida, Forenede Stater
      • Tamarac, Florida, Forenede Stater
      • Tampa, Florida, Forenede Stater
      • West Palm Beach, Florida, Forenede Stater
      • Weston, Florida, Forenede Stater
      • Winter Haven, Florida, Forenede Stater
    • Georgia
      • Decatur, Georgia, Forenede Stater
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater
    • Indiana
      • Indianapolis, Indiana, Forenede Stater
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater
    • Maryland
      • Elkridge, Maryland, Forenede Stater
      • Frederick, Maryland, Forenede Stater
    • Massachusetts
      • Worcester, Massachusetts, Forenede Stater
    • Michigan
      • St. Clair Shores, Michigan, Forenede Stater
      • Traverse City, Michigan, Forenede Stater
    • Mississippi
      • Hattiesburg, Mississippi, Forenede Stater
    • Missouri
      • Kansas City, Missouri, Forenede Stater
      • St. Louis, Missouri, Forenede Stater
    • Nebraska
      • Omaha, Nebraska, Forenede Stater
    • New York
      • Brooklyn, New York, Forenede Stater
      • Hartsdale, New York, Forenede Stater
      • New York, New York, Forenede Stater
      • Plainview, New York, Forenede Stater
      • Rochester, New York, Forenede Stater
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater
      • High Point, North Carolina, Forenede Stater
      • Raleigh, North Carolina, Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
      • Cleveland, Ohio, Forenede Stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
      • Tulsa, Oklahoma, Forenede Stater
    • Pennsylvania
      • Bensalem, Pennsylvania, Forenede Stater
      • Duncansville, Pennsylvania, Forenede Stater
      • Jenkintown, Pennsylvania, Forenede Stater
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater
    • South Carolina
      • Mount Pleasant, South Carolina, Forenede Stater
    • Tennessee
      • Jackson, Tennessee, Forenede Stater
      • Jefferson City, Tennessee, Forenede Stater
      • Memphis, Tennessee, Forenede Stater
    • Texas
      • Cypress, Texas, Forenede Stater
      • Dallas, Texas, Forenede Stater
      • Lubbock, Texas, Forenede Stater
      • Mesquite, Texas, Forenede Stater
      • Plano, Texas, Forenede Stater
      • Waco, Texas, Forenede Stater
    • Utah
      • Salt Lake City, Utah, Forenede Stater
      • Sandy, Utah, Forenede Stater
      • West Jordan, Utah, Forenede Stater
    • Virginia
      • Norfolk, Virginia, Forenede Stater

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Key Inclusion Criteria:

  1. Body mass index ≤39
  2. Clinical diagnosis of OA of the knee or hip
  3. History of inadequate pain relief or intolerance to analgesics used for OA
  4. Moderate to severe pain in the index joint
  5. History of regular use of analgesic medications for OA pain
  6. Willing to discontinue current non-steroidal anti-inflammatory drug (NSAID) and opioid pain medications

Key Exclusion Criteria:

  1. Other diseases that may involve index knee or hip, including inflammatory joint diseases, crystalline disease (gout or pseudogout), endocrinopathies, metabolic joint disease, lupus erythematosus, rheumatoid arthritis, joint infections, neuropathic disorders, avascular necrosis, Paget's disease, renal osteodystrophy or tumors
  2. History of osteonecrosis, destructive arthropathy (RPOA), hip dislocation, pathologic fractures, neuropathic joint arthropathy, knee dislocation or hip dislocation
  3. Trauma to the index joint in the 30 days before screening
  4. Active fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA
  5. Prior to the start of the study has received a recommendation for, or is scheduled for joint replacement surgery to be performed during the study period
  6. Presence of subchondral insufficiency fracture on screening films or MRI
  7. Received an intra-articular injection of hyaluronic acid in the affected index joint within 90 days prior to the screening visit
  8. Systemic (ie, oral or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks of the screening visit, or to any other joint within 30 days prior to the screening visit.
  9. History of autonomic neuropathy, diabetic neuropathy, or presence of clinically relevant peripheral neuropathy at the time of screening
  10. Women of childbearing potential who have a positive pregnancy test result, or who do not have their pregnancy test results at baseline
  11. Pregnant or breastfeeding women

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A
Group A will receive REGN475 dosing regimen 1
Medicin: REGN475
Eksperimentel: Group B
Group B will receive REGN475 dosing regimen 2
Medicin: REGN475
Eksperimentel: Group C
Group C will receive REGN475 dosing regimen 3
Medicin: REGN475
Eksperimentel: Group D
Group D will receive REGN475 dosing regimen 4
Medicin: REGN475
Eksperimentel: Group E
Group E will receive matching placebo
Medicin: Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The primary endpoint in the study is the change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score.
Tidsramme: Baseline to week 16
Baseline to week 16

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline to week 16 in the WOMAC physical function subscale score
Tidsramme: Baseline to week 16
Baseline to week 16
Change from baseline to week 16 in the Patient Global Assessment score
Tidsramme: Baseline to week 16
Baseline to week 16
Incidence of treatment-emergent adverse events (TEAEs)
Tidsramme: Baseline to week 36 (end of study)
Baseline to week 36 (end of study)
Incidence of anti-REGN475 antibody development
Tidsramme: Baseline to week 36 (end of study)
Baseline to week 36 (end of study)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regeneron Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2015

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. november 2016

Datoer for studieregistrering

Først indsendt

14. maj 2015

Først indsendt, der opfyldte QC-kriterier

14. maj 2015

Først opslået (Skøn)

18. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. marts 2017

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R475-PN-1227

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Slidgigt, knæ

Kliniske forsøg med Placebo

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Kingdom

Betingelser

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Narkotikainterventioner

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Sponsor / samarbejdspartnere

Placeringer

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