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En revmatoid artritt-studie hos deltakere (FLEX O)

24. mars 2018 oppdatert av: Eli Lilly and Company

En fase 3, multisenter, randomisert, dobbeltblind, placebokontrollert studie for å evaluere sikkerheten og effekten av LY2127399 hos pasienter med revmatoid artritt (RA) med eller uten bakgrunnssykdomsmodifiserende antirevmatisk medikament (DMARD) terapi (FLEX O) )

Hovedformålet med denne studien er å hjelpe til med å svare på om LY2127399 er trygg og effektiv i behandlingen av revmatoid artritt med eller uten bakgrunnsbehandling med sykdomsmodifiserende antirevmatisk medisin (DMARD).

Denne studien består av 2 perioder:

Periode 1 - 24 ukers blindbehandling

Periode 2 - 48 ukers oppfølging etter behandling

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

I betraktning av sykdommens alvorlighetsgrad ble alle deltakerne vurdert for manglende respons ved uke 16. Totalt 66 ledd ble undersøkt for hevelse, og totalt 66 ledd ble undersøkt for ømhet. For deltakere som hadde minst 5 hovne og 5 ømme ledd ved baseline, ble uke 16 non-responders (NRs) definert som deltakere med <20 % forbedring fra baseline både i antall ømme ledd og hovne ledd. For deltakere som ikke hadde minst 5 hovne og 5 ømme ledd ved baseline, ble uke 16 NR-er definert som deltakere som hadde minst 2 ekstra ømme og 2 ekstra hovne ledd fra baseline. Alle uke 16 NR-er og alle deltakere som avbrøt studiebehandlingen når som helst, uansett grunn, ble definert som NR-er som starter på det tidspunktet og fremover for alle American College of Rheumatology (ACR) imputerte analyser, inkludert uke 24-endepunktet.

Studietype

Intervensjonell

Registrering (Faktiske)

1004

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Córdoba, Argentina, X5016KEH
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mar Del Plata, Argentina, B7600FZN
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rosario, Argentina, 2000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Juan, Argentina, 5400
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tucuman, Argentina, 4000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Australia
      • Malvern East, Australia, 3145
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New South Wales
      • Kogarah, New South Wales, Australia, 04266-010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Queensland
      • Herston, Queensland, Australia, 4029
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pleven, Bulgaria, 5800
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Plovdiv, Bulgaria, 4003
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rousse, Bulgaria, 7002
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sevlievo, Bulgaria, 5400
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sofia, Bulgaria, 1784
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Varna, Bulgaria, 9000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Colombia
      • Bogota, Colombia
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Medellin, Colombia
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Den russiske føderasjonen
      • Barnaul, Den russiske føderasjonen, 656038
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kemerovo, Den russiske føderasjonen, 650066
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kursk, Den russiske føderasjonen, 305007
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Moscow, Den russiske føderasjonen, 111539
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nizhny Novgorod, Den russiske føderasjonen, 603005
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Novosibirsk, Den russiske føderasjonen, 630047
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ryazan, Den russiske føderasjonen, 390026
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saint Petersburg, Den russiske føderasjonen, 197022
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Stavropol, Den russiske føderasjonen, 355017
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35216
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Arizona
      • Paradise Valley, Arizona, Forente stater, 85253
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Peoria, Arizona, Forente stater, 85381
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Phoenix, Arizona, Forente stater, 85018
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Scottsdale, Arizona, Forente stater, 85251
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tucson, Arizona, Forente stater, 85704
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Arkansas
      • Hot Springs, Arkansas, Forente stater, 71913
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Little Rock, Arkansas, Forente stater, 72205
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • California
      • San Diego, California, Forente stater, 92103
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Torrance, California, Forente stater, 90505
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tustin, California, Forente stater, 92780
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Whittier, California, Forente stater, 90606
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wildomar, California, Forente stater, 92595
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80910
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Delaware
      • Lewes, Delaware, Forente stater, 19958
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Florida
      • Aventura, Florida, Forente stater, 33180
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • DeBary, Florida, Forente stater, 32713
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Palm Harbor, Florida, Forente stater, 34684
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pinellas Park, Florida, Forente stater, 33781
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saint Petersburg, Florida, Forente stater, 33716
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tamarac, Florida, Forente stater, 33321
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Venice, Florida, Forente stater, 34292
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zephyrhills, Florida, Forente stater, 33542
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Georgia
      • Decatur, Georgia, Forente stater, 30033
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gainesville, Georgia, Forente stater, 30501
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lawrenceville, Georgia, Forente stater, 30045
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Marietta, Georgia, Forente stater, 30060
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Savannah, Georgia, Forente stater, 31405
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Idaho
      • Eagle, Idaho, Forente stater, 83616
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Illinois
      • Morton Grove, Illinois, Forente stater, 60053
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rockford, Illinois, Forente stater, 61103
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46227
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Kansas
      • Wichita, Kansas, Forente stater, 67208
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Maryland
      • Cumberland, Maryland, Forente stater, 21502
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Massachusetts
      • Hyannis, Massachusetts, Forente stater, 02601
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Worcester, Massachusetts, Forente stater, 01605
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Michigan
      • Bingham Farms, Michigan, Forente stater, 48025
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saint Clair Shores, Michigan, Forente stater, 48081
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Mississippi
      • Flowood, Mississippi, Forente stater, 39232
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Jackson, Mississippi, Forente stater, 39202
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63131
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68516
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Omaha, Nebraska, Forente stater, 68134
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89123
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87108
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New York
      • Brooklyn, New York, Forente stater, 11201
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Roslyn, New York, Forente stater, 11576
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Syracuse, New York, Forente stater, 13210
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28210
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hickory, North Carolina, Forente stater, 28601
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Raleigh, North Carolina, Forente stater, 27609
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45242
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73103
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tulsa, Oklahoma, Forente stater, 74135
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oregon
      • Bend, Oregon, Forente stater, 97701
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forente stater, 18017
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Limerick, Pennsylvania, Forente stater, 19468
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Philadelphia, Pennsylvania, Forente stater, 19152
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pottstown, Pennsylvania, Forente stater, 19464
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • South Carolina
      • Columbia, South Carolina, Forente stater, 29204
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Greenville, South Carolina, Forente stater, 29601
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Greer, South Carolina, Forente stater, 29650
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Myrtle Beach, South Carolina, Forente stater, 29572
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • North Charleston, South Carolina, Forente stater, 29406
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37909
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Memphis, Tennessee, Forente stater, 38119
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nashville, Tennessee, Forente stater, 37205
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • Austin, Texas, Forente stater, 78731
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Dallas, Texas, Forente stater, 75231
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lake Jackson, Texas, Forente stater, 77566
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lubbock, Texas, Forente stater, 79424
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mesquite, Texas, Forente stater, 75150
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nassau Bay, Texas, Forente stater, 77058
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • North Richland Hills, Texas, Forente stater, 76180
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Antonio, Texas, Forente stater, 78217
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sugar Land, Texas, Forente stater, 77478
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Washington
      • Spokane, Washington, Forente stater, 99204
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • India
      • Ahmedabad, India, 3800015
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bangalore, India, 5600092
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Chennai, India, 600100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hyderabaad, India, 500033
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Jaipur, India, 302023
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mysore, India, 570023
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nellore, India, 524003
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • New Delhi, India, 110 076
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Secunderabad, India, 500 003
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Surat, India, 560092
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Japan
      • Aichi, Japan, 460-0001
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Fukuoka, Japan, 820-8505
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gunma, Japan, 370-0053
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hokkaido, Japan, 063-0811
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hyogo, Japan, 650-0017
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ibaragi, Japan, 316-0035
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kanagawa, Japan, 252-0392
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kumamoto, Japan, 861-8520
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mie, Japan, 514-1101
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Miyagi, Japan, 982-0032
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nagano, Japan, 390-8601
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nagasaki, Japan, 857-1195
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nara, Japan, 634-0007
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ohita, Japan, 874-0011
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Okayama, Japan, 712-8044
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Osaka, Japan, 586-8521
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saga, Japan, 843-0393
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saitama, Japan, 337-0012
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sapporo-Shi, Japan, 060-8648
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Shizuoka, Japan, 420-8623
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tokyo, Japan, 185-0012
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tomakomai, Japan, 053-8567
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Korea, Republikken
      • Busan, Korea, Republikken, 602-715
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Daegu, Korea, Republikken, 700-721
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul, Korea, Republikken, 134-727
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Kroatia
      • Opatija, Kroatia, 51410
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rijeka, Kroatia, HR-51000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Split, Kroatia, 21000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Litauen
      • Alytus, Litauen, 62114
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kaunas, Litauen, 49475
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Klaipedos, Litauen, 92288
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Siauliai, Litauen, 73231
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vilnius, Litauen, LT-08661
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Malaysia
      • Batu Caves, Malaysia, 68100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kuantan Pahang, Malaysia, 25100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Perak, Malaysia, 30990
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sarawak, Malaysia, 93586
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Mexico
      • Aguascalientes, Mexico, 20203
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Chihuahua, Mexico, 31000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Guadalajara, Mexico, 44690
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mexicali, Mexico, 21100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mexico City, Mexico, 06100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Monterrey, Mexico, 64000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Morelia, Mexico, 58070
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Queretaro, Mexico, 76000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Luis Potosi, Mexico, 78200
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tijuana, Mexico, 22010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tlalpan, Mexico, 14080
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • New Zealand
      • Hamilton, New Zealand, 3204
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rotorua, New Zealand, 3010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tauranga, New Zealand, 3140
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Timaru, New Zealand
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Polen
      • Bydgoszcz, Polen, 85-168
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Elblag, Polen, 82-300
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gdynia, Polen, 81-384
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Krakow, Polen, 30-510
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lublin, Polen, 20-607
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Torun, Polen, 87-100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Warsaw, Polen, 01-192
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Romania
      • Brasov, Romania, 500365
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cluj-Napoca, Romania, 400130
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Iasi, Romania, 700656
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ploiesti, Romania, 100337
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Slovakia
      • Bratislava, Slovakia, 84231
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Piestany, Slovakia, 921 12
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Sri Lanka
      • Colombo, Sri Lanka
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Galle, Sri Lanka
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kalubowila, Sri Lanka
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nugegoda, Sri Lanka
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Sør-Afrika
      • Benoni, Sør-Afrika, 1500
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bloemfontein, Sør-Afrika, 9301
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Breyten, Sør-Afrika, 2330
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cape Town, Sør-Afrika, 7925
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Durban, Sør-Afrika, 4092
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Limpopo, Sør-Afrika, 0380
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pretoria, Sør-Afrika, 0184
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Somerset West, Sør-Afrika, 7130
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Stellenbosch, Sør-Afrika, 7600
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Westville, Sør-Afrika, 3630
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Taiwan
      • Keelong, Taiwan, 333
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kuei Shan Hsiang, Taiwan, 33305
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taichung, Taiwan, 407
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taipei, Taiwan, 112
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Ukraina
      • Dnipropetrovsk, Ukraina, 49008
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Donetsk, Ukraina, 83045
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kharkiv, Ukraina, 61178
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kiev, Ukraina, 04114
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kyiv, Ukraina, 03151
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Odesa, Ukraina, 65026
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Poltava, Ukraina, 36038
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Simferopol, Ukraina, 95017
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vinnytsya, Ukraina, 21018
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Ungarn
      • Budapest, Ungarn, 1036
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Debrecen, Ungarn, 4032
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kiskunhalas, Ungarn, 6400
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nyiregyhaza, Ungarn, 4400
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Satoraljaujhely, Ungarn, 3980
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Szikszo, Ungarn, 3800
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Veszprem, Ungarn, 8200
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inklusjonskriterier:

  • Diagnose av revmatoid artritt (RA) på mer enn 6 måneder og mindre enn 15 år
  • Global Assessment of Disease Activity visuell analog skala (VAS) større enn eller lik 20/100 millimeter (mm)
  • Hvis på ett eller flere konvensjonelle sykdomsmodifiserende antirevmatiske legemidler (DMARDs) ved randomisering, må det ha vært på en stabil dose i minst 8 uker før studiestart.
  • Kvinner må ikke være gravide, ammende eller bli gravide under studien

Ekskluderingskriterier:

  • Bruk av ustabile doser av ikke-steroide inflammatoriske legemidler (NSAIDS) de siste 6 ukene
  • Steroidinjeksjon eller intravenøs (IV) infusjon de siste 6 ukene
  • Bruk av mer enn 10 milligram per dag (mg/dag) orale steroider de siste 6 ukene
  • Bruk av biologisk DMARD samtidig eller nylig
  • Historie om en alvorlig reaksjon på andre biologiske DMARDs
  • Bruk av en oral kalsineurinhemmer (for eksempel ciklosporin eller takrolimus) de siste 8 ukene
  • Kirurgi på en ledd eller annen større operasjon mindre enn 2 måneder før studiestart, eller planlegger å ha leddkirurgi eller større operasjon under studien
  • Aktiv fibromyalgi, juvenil kronisk artritt, spondyloartropati, Crohns sykdom, ulcerøs kolitt, psoriasisartritt eller annen systemisk inflammatorisk tilstand unntatt RA
  • Livmorhalskreft eller plateepitelkreft innen de siste 3 årene, eller annen kreft innen de siste 5 årene
  • Mottatt en levende vaksine i løpet av de siste 12 ukene (for eksempel vaksiner mot meslinger, kusma, røde hunder og vannkopper, og nesespray influensavaksiner)
  • Hepatitt eller humant immunsviktvirus (HIV)
  • En alvorlig bakteriell infeksjon (for eksempel lungebetennelse eller cellulitt) innen 3 måneder eller en alvorlig bein- eller leddinfeksjon innen 6 måneder
  • Symptomer på herpes zoster eller herpes simplex i løpet av den siste måneden
  • Aktiv eller latent tuberkulose (TB)
  • Aktuelle symptomer på en alvorlig lidelse eller sykdom
  • Bruk av et undersøkelsesmiddel i løpet av den siste måneden

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 120 mg LY2127399

LY2127399: 120 milligram (mg), subkutan (SC) injeksjon, hver 4. uke i 24 uker. Deltakerne fikk en 240 mg (2 SC-injeksjoner på 120 mg hver) startdose på LY2127399 ved oppstart av behandling.

I løpet av behandlingsperioden, for blendende formål, vekslet deltakerne injeksjoner av LY2127399 og injeksjoner med placebo hver 2. uke.

Etter 16 uker mottok ikke-responderende 90 mg LY2127399 hver 2. uke resten av den 24-ukers behandlingsperioden.
Legemiddel: Placebo
Legemiddel: LY2127399
Andre navn:
  • Tabalumab
Eksperimentell: 90 mg LY2127399

LY2127399: 90 milligram (mg), subkutan (SC) injeksjon, annenhver uke i 24 uker. Deltakerne fikk en 180 mg (2 SC-injeksjoner på 90 mg hver) startdose på LY2127399 ved oppstart av behandling.

Etter 16 uker fortsatte ikke-responderende å motta 90 mg LY2127399 hver 2. uke resten av den 24 uker lange behandlingsperioden.
Legemiddel: LY2127399
Andre navn:
  • Tabalumab
Placebo komparator: Placebo

Placebo: subkutan (SC) injeksjon, hver 2. uke i 24 uker. Deltakerne fikk en startdose på 2 SC-injeksjoner med placebo ved oppstart av behandling.

Etter 16 uker mottok ikke-responderende 90 milligram (mg) LY2127399 annenhver uke for resten av den 24-ukers behandlingsperioden.
Legemiddel: Placebo
Legemiddel: LY2127399
Andre navn:
  • Tabalumab

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentandel av deltakere med American College of Rheumatology 20 % (ACR20) svar
Tidsramme: Inntil 24 uker
ACR20 Responder Index: Sammensetning av kliniske, laboratorie- og funksjonelle mål for revmatoid artritt. ACR20 Responder: hadde >=20 % forbedring fra baseline i både 68 ømme og 66 hovne ledd og >=20 % forbedring i minst 3 av 5 kriterier: deltakerens og legens globale vurdering av sykdomsaktivitet, Health Assessment Questionnaire-Disability Index ( HAQ-DI) (som målte deltakernes opplevde vanskelighetsgrad med å utføre daglige aktiviteter), leddsmerter og C-reaktivt protein (CRP). Prosentandel av deltakere som oppnår ACR20-svar=(antall ACR20-svar/antall behandlede deltakere)*100. Alle ikke-responderere ved uke 16, så vel som alle deltakere som avbrøt studiebehandlingen når som helst, uansett årsak, ble definert som ikke-responderere fra det tidspunktet og fremover, inkludert uke 24-endepunkt.
Inntil 24 uker

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentandel av deltakere med American College of Rheumatology 50 % (ACR50) og 70 % (ACR70) svar
Tidsramme: Inntil 24 uker
ACR Responder Index: Sammensetning av kliniske, laboratoriemessige og funksjonelle mål for revmatoid artritt. ACR50 Responder: hadde >=50 % bedring fra baseline i både 68 ømme ledd (TJ) og 66 hovne ledd (SJ) og >=50 % forbedring i minst 3/5 kriterier: deltakerens (Pts) og legens globale vurdering av sykdomsaktivitet, HAQ-DI (målte Pts' opplevde vanskelighetsgrad med å utføre daglige aktiviteter), leddsmerter og CRP. Prosentandel av Pt som oppnår ACR50-respons=(antall (antall) ACR50-respondere/antall Pts behandlet)*100. ACR70-responder: hadde >=70 % forbedring fra baseline i både TJ- og SJ-tall og >=70 % forbedring i minst 3 av de samme 5 kriteriene for ACR50. Prosentandel av Pts som oppnår ACR70-respons=(Antall ACR70-respondere/Antall Pts behandlet)*100. Alle ikke-responderere ved uke 16, så vel som alle Pts som avbrøt studiebehandlingen når som helst, uansett årsak, ble definert som ikke-responderere fra det tidspunktet og fremover, inkludert uke 24-endepunkt.
Inntil 24 uker
Gjennomsnittlig prosentvis forbedring i American College of Rheumatology prosentvis forbedring (ACR-N)
Tidsramme: Inntil 24 uker
ACR-N er et kontinuerlig mål på kliniske, laboratoriemessige og funksjonelle utfall ved revmatoid artritt som karakteriserer prosentvis forbedring i sykdomsaktivitet fra baseline basert på ACR-kjernesett. Prosentandel av forbedring ble avkortet til området -100 til 100 for å minimere effekten av uteliggere (større verdier indikerer større prosentvis forbedring). Denne indeksen ble beregnet som minimum av a) prosentandel av forbedring i TJ-antall, b) prosentandel av forbedring i SJ-antall, eller c) tredje høyeste prosentandel av forbedring av gjenværende 5 ACR-kjernekriterier: Hvis >=3 komponenter av 5 ACR-kjernen kriterier manglet, deretter ble c) satt til manglende; hvis noen av 3 komponentene a), b) eller c) manglet, ble ACR-N satt til manglende. Least Squares (LS)-middelverdier ble beregnet ved å bruke analyse av kovarians (ANCOVA) med behandling, region, behandlingshistorie med tumornekrosefaktor-inadequat responder og sykdomsmodifiserende anti-reumatisk medikament (DMARD) bakgrunn som faste faktorer og baseline som en kovariat.
Inntil 24 uker
Endring fra baseline til 24 uker i anbudsmengde (68 fellestellinger)
Tidsramme: Baseline, opptil 24 uker
Tall for ømme ledd er antall ømme og smertefulle ledd bestemt for hver deltaker ved undersøkelse av 68 ledd. Ledd ble vurdert ved trykk og leddmanipulasjon ved fysisk undersøkelse. Deltakerne ble spurt om smerteopplevelser på disse manipulasjonene og fulgte med på spontane smertereaksjoner. Enhver positiv respons på trykk, bevegelse eller begge deler blir oversatt til en enkelt øm-mot-ikke-tender-dikotomi. LS-middelverdier ble beregnet ved bruk av ANCOVA med behandling, region, tumornekrosefaktor-inadequat responder-behandlingshistorie og DMARD-bakgrunn som faste faktorer og baseline som en kovariat.
Baseline, opptil 24 uker
Endring fra baseline til 24 uker i hovne ledd (66 ledd)
Tidsramme: Baseline, opptil 24 uker
Antall hovne ledd er antallet hovne ledd bestemt for hver deltaker ved undersøkelse av 66 ledd. Leddene ble klassifisert som enten hovne eller ikke hovne. Hevelse ble definert som palpabel fluktuerende synovitt i leddet. LS-middelverdier ble beregnet ved bruk av ANCOVA med behandling, region, tumornekrosefaktor-inadequat responder-behandlingshistorie og DMARD-bakgrunn som faste faktorer og baseline som en kovariat.
Baseline, opptil 24 uker
Endring fra baseline til 24 uker i deltakerens vurdering av smerte (visuell analog skala)
Tidsramme: Baseline, opptil 24 uker
Deltakerens vurdering av deres nåværende leddgiktsmerte ved bruk av en visuell analog skala (VAS) varierte fra 0 millimeter (mm) (ingen smerte) til 100 mm (verst mulig smerte). En nedgang i smertescore indikerte en bedring i deltakerens tilstand. LS-middelverdier ble beregnet ved bruk av ANCOVA med behandling, region, tumornekrosefaktor-inadequat responder-behandlingshistorie og DMARD-bakgrunn som faste faktorer og baseline som en kovariat.
Baseline, opptil 24 uker
Endring fra baseline til 24 uker i deltakerens globale vurdering av sykdomsaktivitet (visuell analog skala)
Tidsramme: Baseline, opptil 24 uker
Deltagerens vurdering av deres nåværende leddgiktsykdomsaktivitet ved bruk av en visuell analog skala (VAS) varierte fra 0 millimeter (mm) (ingen leddgiktaktivitet) til 100 mm (ekstremt aktiv leddgikt). En reduksjon i sykdomsaktivitetsscore indikerte en bedring i deltakerens tilstand. LS-middelverdier ble beregnet ved bruk av ANCOVA med behandling, region, tumornekrosefaktor-inadequat responder-behandlingshistorie og DMARD-bakgrunn som faste faktorer og baseline som en kovariat.
Baseline, opptil 24 uker
Endring fra baseline til 24 uker i leges globale vurdering av sykdomsaktivitet (visuell analog skala)
Tidsramme: Baseline, opptil 24 uker
Legens vurdering av deltakerens nåværende artrittsykdomsaktivitet ved bruk av en visuell analog skala (VAS) varierte fra 0 millimeter (mm) (ingen leddgiktaktivitet) til 100 mm (ekstremt aktiv leddgikt). En reduksjon i sykdomsaktivitetsscore indikerte en bedring i deltakerens tilstand. LS-middelverdier ble beregnet ved bruk av ANCOVA med behandling, region, tumornekrosefaktor-inadequat responder-behandlingshistorie og DMARD-bakgrunn som faste faktorer og baseline som en kovariat.
Baseline, opptil 24 uker
Endring fra baseline til 24 uker i sykdomsaktivitetspoeng (Basert på 28 leddantall)-C-reaktivt protein (DAS28-CRP)
Tidsramme: Baseline, opptil 24 uker
Disease Activity Score (DAS) modifisert til å inkludere 28 leddtellinger (DAS28) besto av sammensatt poengsum av følgende variabler: antall ømme ledd (TJC28), antall hovne ledd (SJC28), C-reaktivt protein (CRP) (milligram per liter), og deltaker global vurdering av sykdomsaktivitet ved bruk av visuell analog skala (VAS) (deltaker global VAS). DAS28-CRP ble beregnet ved å bruke følgende formel: DAS28-CRP=0,56*kvadrat root (sqrt)(TJC28)+0,28*sqrt(SJC28)+0,36*naturlig log(CRP+1)+0,014*deltaker global VAS+0,96. Poengene varierte 1,0–9,4, der lavere skårer indikerte mindre sykdomsaktivitet og remisjon er DAS28-CRP <2,6. En nedgang i DAS28-CRP indikerte en bedring i deltakerens tilstand. LS-middelverdier ble beregnet ved bruk av ANCOVA med behandling, region, tumornekrosefaktor-inadequat responder-behandlingshistorie og DMARD-bakgrunn som faste faktorer og baseline som en kovariat.
Baseline, opptil 24 uker
Endring fra baseline til 24 uker i helsevurdering spørreskjema-funksjonshemming Index (HAQ-DI)
Tidsramme: Baseline, opptil 24 uker
HAQ-DI-spørreskjemaet vurderer deltakerens selvoppfatning av vanskelighetsgraden [0 (uten vanskeligheter), 1 (med noen vanskeligheter), 2 (med store vanskeligheter) og 3 (ikke i stand til å gjøre det)] ved påkledning og stell. , reise seg, spise, gå, hygiene, strekke seg, gripe og utføre andre daglige aktiviteter. Poeng for hvert funksjonsområde, som varierte fra 0 (ingen funksjonshemming) til 3 (alvorlig funksjonshemming), ble beregnet i gjennomsnitt for å beregne HAQ-DI. En nedgang i HAQ-DI-score indikerte en bedring i deltakerens tilstand. LS-middelverdier ble beregnet ved bruk av ANCOVA med behandling, region, tumornekrosefaktor-inadequat responder-behandlingshistorie og DMARD-bakgrunn som faste faktorer og baseline som en kovariat.
Baseline, opptil 24 uker
Tid til American College of Rheumatology 20 % (ACR20) svar
Tidsramme: Baseline gjennom 24 uker

ACR20 Responder Index: Sammensetning av kliniske, laboratorie- og funksjonelle mål for revmatoid artritt. ACR20 Responder: hadde >= 20 % forbedring fra baseline i både 68 ømme og 66 hovne ledd og >=20 % forbedring i minst 3 av 5 kriterier: deltakerens og legens globale vurdering av sykdomsaktivitet, Health Assessment Questionnaire-Disability Index ( HAQ-DI) (som målte deltakernes opplevde vanskelighetsgrad med å utføre daglige aktiviteter), leddsmerter og C-reaktivt protein (CRP). Kaplan-Meier-estimatoren ble brukt til å oppsummere tid til ACR20-respons over behandlingsperioden (24 uker). Tiden til American College of Rheumatology 20 % (ACR20) respons (i uker) beregnes som:

(Dato for første postbaseline-besøk i løpet av behandlingsperioden som oppfyller ACR20-responskriterier - Dato for første injeksjon av studiebehandling + 1) / 7.
Baseline gjennom 24 uker
Sannsynlighet for et ACR20-svar innen 24 uker
Tidsramme: Baseline gjennom 24 uker

ACR20 Responder Index: Sammensetning av kliniske, laboratorie- og funksjonelle mål for revmatoid artritt. ACR20 Responder: hadde >= 20 % forbedring fra baseline i både 68 ømme og 66 hovne ledd og >=20 % forbedring i minst 3 av 5 kriterier: deltakerens og legens globale vurdering av sykdomsaktivitet, Health Assessment Questionnaire-Disability Index ( HAQ-DI) (som målte deltakernes opplevde vanskelighetsgrad med å utføre daglige aktiviteter), leddsmerter og C-reaktivt protein (CRP). Kaplan-Meier-estimatoren ble brukt til å oppsummere tid til ACR20-respons over behandlingsperioden (24 uker). Tiden til American College of Rheumatology 20 % (ACR20) respons (i uker) beregnes som:

(Dato for første postbaseline-besøk i løpet av behandlingsperioden som oppfyller ACR20-responskriterier - Dato for første injeksjon av studiebehandling + 1) / 7.
Baseline gjennom 24 uker
Prosentandel av deltakere med DAS28-basert European League Against Rheumatism (EULAR) respons
Tidsramme: Inntil 24 uker
EULAR Responder-indeks basert på 28 leddtellinger kategoriserer klinisk respons basert på forbedring siden baseline i DAS28-CRP. Deltakere er kategorisert som EULAR-respondere eller ikke-responderere basert på forbedring av DAS28-CRP-score fra baseline. EULAR28 responder er definert som enten DAS28-CRP <=5,1 og DAS28-CRP endring <-0,6; eller DAS28-CRP >5.1 og DAS28-CRP endring <-1.2. EULAR28 responder indeks er definert som god respons: DAS28-CRP <=3,2 og DAS28-CRP endring <-1,2; moderat respons: DAS28-CRP endring <-1,2 bortsett fra tilfeller definert i god respons; eller DAS28-CRP <=5.1 og DAS28-CRP endring <-0.6 og >-1.2. EULAR-remisjon er definert som en DAS28-CRP-score på <2,6.
Inntil 24 uker
Endring fra baseline til 24 uker i medisinske resultater Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores
Tidsramme: Baseline, opptil 24 uker
SF-36 er en helserelatert undersøkelse som vurderer deltakerens livskvalitet og består av 36 spørsmål som dekker 8 helsedomener: fysisk funksjon, kroppslige smerter, rollebegrensninger på grunn av fysiske problemer og følelsesmessige problemer, generell helse, mental helse, sosial funksjon. , vitalitet og 2 komponentscore (mental [MCS] og fysisk helse [PCS]). Domenepoeng beregnes ved å summere hvert element for hvert domene og transformere poengsum til en skala fra 0-100; høyere skårer indikerte bedre helsetilstand. MCS-score besto av sosial funksjon, vitalitet, mental helse og rolleemosjonelle skalaer. PCS-score besto av fysisk funksjon, kroppslig smerte, rolle-fysisk og generell helseskala. LS-middelverdier ble beregnet ved bruk av ANCOVA med behandling, region, tumornekrosefaktor-inadequat responder-behandlingshistorie og DMARD-bakgrunn som faste faktorer og baseline som en kovariat.
Baseline, opptil 24 uker
Endring fra baseline i C-reaktivt protein (CRP) opp til uke 24 endepunkt
Tidsramme: Baseline, opptil 24 uker
CRP er en indikator på betennelse. En negativ endring indikerte en bedring i deltakerens tilstand. LS-middelverdier ble beregnet ved bruk av ANCOVA med behandling, region, tumornekrosefaktor-inadequat responder-behandlingshistorie og DMARD-bakgrunn som faste faktorer og baseline som en kovariat.
Baseline, opptil 24 uker
Endring fra baseline til 24 uker i absolutt CD3-CD20+ B-celletall
Tidsramme: Baseline, opptil 24 uker
Celleoverflatemarkørklyngebetegnelse (CD) 3 negativ, CD20 positiv (CD3-CD20+) definerer totale modne B-celler. B-lymfocyttantigen CD20 er et aktivert-glykosylert fosfoprotein uttrykt på overflaten av alle modne B-celler. Baseline B-celletall bestemmes ved å beregne gjennomsnittet av de 2 B-celletellingene før behandling oppnådd én gang i løpet av dag -28 til -7 og på dag 0. En positiv eller negativ endring indikerte henholdsvis en økning eller reduksjon i B-celleantallet . LS-middelverdier ble beregnet ved bruk av ANCOVA med behandling, region, tumornekrosefaktor-inadequat responder-behandlingshistorie og DMARD-bakgrunn som faste faktorer og baseline som en kovariat.
Baseline, opptil 24 uker
Endring fra baseline til 24 uker i serumimmunoglobulin (Ig) nivåer
Tidsramme: Baseline, opptil 24 uker
Immunoglobuliner, eller antistoffer, er store proteiner som brukes av immunsystemet for å identifisere og nøytralisere fremmede partikler som bakterier og virus. Deres normale blodnivåer indikerer riktig immunstatus. Endring fra baseline serum immunoglobulin G (IgG), immunglobulin A (IgA) og immunglobulin M (IgM) nivåer er rapportert. En negativ endring indikerte en reduksjon i immunglobulinnivåer. LS-middelverdier ble beregnet ved bruk av ANCOVA med behandling, region, tumornekrosefaktor-inadequat responder-behandlingshistorie og DMARD-bakgrunn som faste faktorer og baseline som en kovariat.
Baseline, opptil 24 uker
Populasjonsfarmakokinetikk (PK)
Tidsramme: Baseline gjennom 24 uker
Populasjonsestimat for konstant clearance som bestemt ved populasjonsfarmakokinetikk (PK) analyse. En 2-roms modell ble brukt i PK-modellering.
Baseline gjennom 24 uker
Prosentandel av deltakere som utvikler anti-LY2127399 antistoffer
Tidsramme: Baseline gjennom 24 uker
LY2127399 anti-medikamentantistoffer (ADA) ble vurdert ved baseline, 1, 4, 16 og 24 uker. Andel deltakere (Pts) med ADA=(antall Pts med behandlingsfremkommende ADA/antall Pts vurdert)*100. Pts med behandlingsfremkommet ADA var Pts som hadde en hvilken som helst prøve fra baseline til og gjennom uke 24 som var en 4-dobling (2-fortynningsøkning) i immunogenisitetstiter over baseline titer, eller Pts som testet negativt ved baseline og positiv post -grunnlinje (ved titer på ≥1:20).
Baseline gjennom 24 uker

Samarbeidspartnere og etterforskere

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Sponsor

Eli Lilly and Company

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2011

Primær fullføring (Faktiske)

1. desember 2012

Studiet fullført (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først innsendt

14. september 2010

Først innsendt som oppfylte QC-kriteriene

14. september 2010

Først lagt ut (Anslag)

16. september 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. mars 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 12978
  • H9B-MC-BCDO (Annen identifikator: Eli Lilly and Company)
  • CTRI/2011/07/001867 (Registeridentifikator: Clinical Trials Registry India)

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