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En reumatoid arthritis-undersøgelse hos deltagere (FLEX O)

24. marts 2018 opdateret af: Eli Lilly and Company

En fase 3, multicenter, randomiseret, dobbeltblind, placebokontrolleret undersøgelse til evaluering af sikkerheden og effektiviteten af ​​LY2127399 hos patienter med reumatoid arthritis (RA) med eller uden baggrundssygdomsmodificerende anti-reumatisk medicin (DMARD) terapi (FLEX O) )

Det primære formål med denne undersøgelse er at hjælpe med at besvare, om LY2127399 er sikker og effektiv til behandling af leddegigt med eller uden baggrundsbehandling med sygdomsmodificerende anti-rheumatic drug (DMARD).

Denne undersøgelse består af 2 perioder:

Periode 1 - 24 ugers blindbehandling

Periode 2 - 48 ugers opfølgning efter behandling

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

I betragtning af sygdommens sværhedsgrad blev alle deltagere vurderet for manglende respons i uge 16. I alt 66 led blev undersøgt for hævelse, og i alt 66 led blev undersøgt for ømhed. For deltagere, der havde mindst 5 hævede og 5 ømme led ved baseline, blev uge 16 non-responders (NR'er) defineret som deltagere med <20 % forbedring fra baseline i både ømme led og hævede led. For deltagere, der ikke havde mindst 5 hævede og 5 ømme led ved baseline, blev uge 16 NR'er defineret som deltagere, der havde mindst 2 yderligere ømme og 2 yderligere hævede led fra baseline. Alle Uge 16 NR'er og alle deltagere, der afbrød undersøgelsesbehandling på et hvilket som helst tidspunkt og af en eller anden grund, blev defineret som NR'er startende på det tidspunkt og fremadrettet for alle American College of Rheumatology (ACR) imputerede analyser, inklusive uge 24 endepunktet.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1004

Fase

  • Fase 3

Kontakter og lokationer

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

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.
  • Australien
      • Malvern East, Australien, 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, Australien, 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, Australien, 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.
  • Bulgarien
      • Burgas, Bulgarien, 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, Bulgarien, 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, Bulgarien, 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, Bulgarien, 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, Bulgarien, 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, Bulgarien, 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, Bulgarien, 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 Føderation
      • Barnaul, Den Russiske Føderation, 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 Føderation, 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 Føderation, 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 Føderation, 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 Føderation, 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 Føderation, 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 Føderation, 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 Føderation, 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 Føderation, 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.
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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.
  • Indien
      • Ahmedabad, Indien, 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, Indien, 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, Indien, 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, Indien, 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, Indien, 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, Indien, 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, Indien, 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, Indien, 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, Indien, 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, Indien, 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.
  • Kroatien
      • Opatija, Kroatien, 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, Kroatien, 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, Kroatien, 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.
  • Rumænien
      • Brasov, Rumænien, 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, Rumænien, 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, Rumænien, 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, Rumænien, 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.
  • Slovakiet
      • Bratislava, Slovakiet, 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, Slovakiet, 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.
  • Sydafrika
      • Benoni, Sydafrika, 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, Sydafrika, 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, Sydafrika, 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, Sydafrika, 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, Sydafrika, 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, Sydafrika, 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, Sydafrika, 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, Sydafrika, 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, Sydafrika, 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, Sydafrika, 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.
  • Ukraine
      • Dnipropetrovsk, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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.

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

  • Diagnose af reumatoid arthritis (RA) på mere end 6 måneder og mindre end 15 år
  • Global vurdering af sygdomsaktivitet visuel analog skala (VAS) større end eller lig med 20/100 millimeter (mm)
  • Hvis på et eller flere konventionelle sygdomsmodificerende anti-gigt lægemidler (DMARDs) ved randomisering, skal den have været på en stabil dosis i mindst 8 uger før studiestart.
  • Kvinder må ikke være gravide, amme eller blive gravide under undersøgelsen

Ekskluderingskriterier:

  • Brug af ustabile doser af ikke-steroide inflammatoriske lægemidler (NSAIDS) inden for de seneste 6 uger
  • Steroidinjektion eller intravenøs (IV) infusion inden for de sidste 6 uger
  • Brug af mere end 10 milligram per dag (mg/dag) orale steroider i de sidste 6 uger
  • Brug af biologisk DMARD samtidig eller for nylig
  • Anamnese med en alvorlig reaktion på andre biologiske DMARD'er
  • Brug af en oral calcineurinhæmmer (f.eks. cyclosporin eller tacrolimus) inden for de sidste 8 uger
  • Operation af en led eller anden større operation mindre end 2 måneder før studiestart, eller planlægger at få foretaget ledoperation eller større operation under studiet
  • Aktiv fibromyalgi, juvenil kronisk arthritis, spondyloarthropati, Crohns sygdom, colitis ulcerosa, psoriasisgigt eller anden systemisk inflammatorisk tilstand undtagen RA
  • Livmoderhalskræft eller pladecellekræft inden for de seneste 3 år, eller anden kræft inden for de seneste 5 år
  • Modtaget en levende vaccine inden for de seneste 12 uger (f.eks. vacciner mod mæslinger, fåresyge, røde hunde og skoldkopper og næsespray-influenzavacciner)
  • Hepatitis eller human immundefektvirus (HIV)
  • En alvorlig bakteriel infektion (f.eks. lungebetændelse eller cellulitis) inden for 3 måneder eller en alvorlig knogle- eller ledinfektion inden for 6 måneder
  • Symptomer på herpes zoster eller herpes simplex inden for den sidste måned
  • Aktiv eller latent tuberkulose (TB)
  • Aktuelle symptomer på en alvorlig lidelse eller sygdom
  • Brug af et forsøgslægemiddel inden for den seneste måned

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: 120 mg LY2127399

LY2127399: 120 milligram (mg), subkutan (SC) injektion, hver 4. uge i 24 uger. Deltagerne modtog en 240-mg (2 SC-injektioner på hver 120 mg) startdosis af LY2127399, da de påbegyndte behandlingen.

I løbet af behandlingsperioden skiftede deltagerne til blinde formål injektioner af LY2127399 og injektioner af placebo hver anden uge.

Efter 16 uger modtog ikke-responderende 90 mg LY2127399 hver anden uge i resten af ​​den 24-ugers behandlingsperiode.
Medicin: Placebo
Medicin: LY2127399
Andre navne:
  • Tabalumab
Eksperimentel: 90 mg LY2127399

LY2127399: 90 milligram (mg), subkutan (SC) injektion, hver 2. uge i 24 uger. Deltagerne modtog en 180 mg (2 SC-injektioner på hver 90 mg) startdosis af LY2127399, da de påbegyndte behandlingen.

Efter 16 uger fortsatte ikke-responderende med at modtage 90 mg LY2127399 hver anden uge i resten af ​​den 24-ugers behandlingsperiode.
Medicin: LY2127399
Andre navne:
  • Tabalumab
Placebo komparator: Placebo

Placebo: subkutan (SC) injektion, hver 2. uge i 24 uger. Deltagerne modtog en startdosis på 2 SC-injektioner af placebo, da de påbegyndte behandlingen.

Efter 16 uger modtog ikke-responderende 90 milligram (mg) LY2127399 hver anden uge i resten af ​​den 24-ugers behandlingsperiode.
Medicin: Placebo
Medicin: LY2127399
Andre navne:
  • Tabalumab

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere med American College of Rheumatology 20 % (ACR20) svar
Tidsramme: Op til 24 uger
ACR20 Responder Index: Sammensætning af kliniske, laboratoriemæssige og funktionelle målinger af reumatoid arthritis. ACR20 Responder: havde >=20 % forbedring fra baseline i både 68 ømme og 66 hævede led og >=20 % forbedring i mindst 3 ud af 5 kriterier: deltagers og læges globale vurdering af sygdomsaktivitet, Health Assessment Questionnaire-Disability Index ( HAQ-DI) (som målte deltagernes oplevede sværhedsgrad ved at udføre daglige aktiviteter), ledsmerter og C-reaktivt protein (CRP). Procentdel af deltagere, der opnår ACR20-svar=(antal ACR20-respondenter/antal behandlede deltagere)*100. Alle ikke-responderere i uge 16 såvel som alle deltagere, der afbrød undersøgelsesbehandling på et hvilket som helst tidspunkt og af en eller anden grund, blev defineret som ikke-responderende fra det tidspunkt og fremadrettet, inklusive endepunkt for uge 24.
Op til 24 uger

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere med American College of Rheumatology 50 % (ACR50) og 70 % (ACR70) svar
Tidsramme: Op til 24 uger
ACR Responder Index: Sammensætning af kliniske, laboratoriemæssige og funktionelle mål for leddegigt. ACR50 Responder: havde >=50 % forbedring fra baseline i både 68 ømme led (TJ) og 66 hævede led (SJ) tællinger og >=50 % forbedring i mindst 3/5 kriterier: deltagers (Pt's) og læges globale vurdering af sygdomsaktivitet, HAQ-DI (målte Pts' oplevede sværhedsgrad ved at udføre daglige aktiviteter), ledsmerter og CRP. Procentdel af Pt, der opnår ACR50-respons=(antal (antal) ACR50-respondere/antal behandlede Pt'er)*100. ACR70-responder: havde >=70 % forbedring fra baseline i både TJ- og SJ-tal og >=70 % forbedring i mindst 3 af de samme 5 kriterier for ACR50. Procentdel af Pt'er, der opnår ACR70-respons=(Antal ACR70-respondere/Antal Pt'er behandlet)*100. Alle ikke-responderere i uge 16 såvel som alle Pts, der afbrød undersøgelsesbehandling på et hvilket som helst tidspunkt og af en eller anden grund, blev defineret som non-responders, der startede på det tidspunkt og fremadrettet, inklusive endepunkt i uge 24.
Op til 24 uger
Gennemsnitlig forbedring i procent i American College of Rheumatology procentvis forbedring (ACR-N)
Tidsramme: Op til 24 uger
ACR-N er et kontinuerligt mål for kliniske, laboratoriemæssige og funktionelle resultater i reumatoid arthritis, der karakteriserer procentvis forbedring i sygdomsaktivitet fra baseline baseret på ACR-kernesæt. Procentdel af forbedring blev afkortet til et område på -100 til 100 for at minimere effekten af ​​outliers (større værdier indikerer større procentvis forbedring). Dette indeks blev beregnet som minimum af a) procentdel af forbedring i TJ-antal, b) procentdel af forbedring i SJ-antal eller c) tredje højeste procentdel af forbedring af resterende 5 ACR-kernekriterier: Hvis >=3 komponenter af 5 ACR-kernen kriterier manglede, så c) blev sat til manglende; hvis nogen af ​​3 komponenter a), b) eller c) manglede, blev ACR-N indstillet til manglende. Mindste kvadraters (LS)-middelværdier blev beregnet ved hjælp af analyse af kovarians (ANCOVA) med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og sygdomsmodificerende anti-rheumatic drug (DMARD) baggrund som faste faktorer og baseline som en kovariat.
Op til 24 uger
Ændring fra basislinje til 24 uger i tællerenhed (68 fællesantal)
Tidsramme: Baseline, op til 24 uger
Ømme ledtal er antallet af ømme og smertefulde led bestemt for hver deltager ved undersøgelse af 68 led. Led blev vurderet ved tryk og ledmanipulation ved fysisk undersøgelse. Deltagerne blev bedt om smertefornemmelser ved disse manipulationer og holdt øje med spontane smertereaktioner. Enhver positiv respons på tryk, bevægelse eller begge dele oversættes til en enkelt øm-versus-ikke-tender-dikotomi. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og DMARD-baggrund som faste faktorer og baseline som en kovariat.
Baseline, op til 24 uger
Skift fra baseline til 24 uger i hævede led (66 led)
Tidsramme: Baseline, op til 24 uger
Hævede led er antallet af hævede led bestemt for hver deltager ved undersøgelse af 66 led. Led blev klassificeret som enten hævede eller ikke hævede. Hævelse blev defineret som palpabel fluktuerende synovitis i leddet. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og DMARD-baggrund som faste faktorer og baseline som en kovariat.
Baseline, op til 24 uger
Ændring fra baseline til 24 uger i deltagerens vurdering af smerte (visuel analog skala)
Tidsramme: Baseline, op til 24 uger
Deltagerens vurdering af deres nuværende gigtsmerter ved hjælp af en visuel analog skala (VAS) varierede fra 0 millimeter (mm) (ingen smerte) til 100 mm (værst mulig smerte). Et fald i smertescore indikerede en forbedring af deltagerens tilstand. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og DMARD-baggrund som faste faktorer og baseline som en kovariat.
Baseline, op til 24 uger
Ændring fra baseline til 24 uger i deltagerens globale vurdering af sygdomsaktivitet (visuel analog skala)
Tidsramme: Baseline, op til 24 uger
Deltagerens vurdering af deres aktuelle gigtsygdomsaktivitet ved hjælp af en visuel analog skala (VAS) varierede fra 0 millimeter (mm) (ingen arthritisaktivitet) til 100 mm (ekstremt aktiv arthritis). Et fald i sygdomsaktivitetsscore indikerede en forbedring af deltagerens tilstand. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og DMARD-baggrund som faste faktorer og baseline som en kovariat.
Baseline, op til 24 uger
Ændring fra baseline til 24 uger i lægens globale vurdering af sygdomsaktivitet (visuel analog skala)
Tidsramme: Baseline, op til 24 uger
Lægens vurdering af deltagerens aktuelle gigtsygdomsaktivitet ved hjælp af en visuel analog skala (VAS) varierede fra 0 millimeter (mm) (ingen arthritisaktivitet) til 100 mm (ekstremt aktiv arthritis). Et fald i sygdomsaktivitetsscore indikerede en forbedring af deltagerens tilstand. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og DMARD-baggrund som faste faktorer og baseline som en kovariat.
Baseline, op til 24 uger
Ændring fra baseline til 24 uger i sygdomsaktivitetsscore (baseret på 28 led)-C-reaktivt protein (DAS28-CRP)
Tidsramme: Baseline, op til 24 uger
Disease Activity Score (DAS) modificeret til at omfatte 28 ledtal (DAS28) bestod af sammensat score af følgende variabler: antal ømme led (TJC28), antal hævede led (SJC28), C-reaktivt protein (CRP) (milligram pr. liter), og deltager global vurdering af sygdomsaktivitet ved hjælp af visuel analog skala (VAS) (deltager global VAS). DAS28-CRP blev beregnet ved hjælp af følgende formel: DAS28-CRP=0,56*kvadrat root (sqrt)(TJC28)+0,28*sqrt(SJC28)+0,36*naturlig log(CRP+1)+0,014*deltager global VAS+0,96. Score varierede 1,0-9,4, hvor lavere score indikerede mindre sygdomsaktivitet og remission er DAS28-CRP <2,6. Et fald i DAS28-CRP indikerede en forbedring i deltagerens tilstand. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og DMARD-baggrund som faste faktorer og baseline som en kovariat.
Baseline, op til 24 uger
Ændring fra baseline til 24 uger i sundhedsvurderingsspørgeskema-handicapindeks (HAQ-DI)
Tidsramme: Baseline, op til 24 uger
HAQ-DI-spørgeskemaet vurderer deltagerens selvopfattelse på sværhedsgraden [0 (uden besvær), 1 (med lidt besvær), 2 (med meget besvær) og 3 (ikke i stand til at gøre)] ved påklædning og pleje. , rejse sig, spise, gå, hygiejne, række ud, gribe og udføre andre daglige aktiviteter. Score for hvert funktionsområde, som varierede fra 0 (ingen funktionsnedsættelse) til 3 (alvorligt handicap), blev beregnet som gennemsnit for at beregne HAQ-DI. Et fald i HAQ-DI-score indikerede en forbedring af deltagerens tilstand. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og DMARD-baggrund som faste faktorer og baseline som en kovariat.
Baseline, op til 24 uger
Tid til American College of Rheumatology 20 % (ACR20) svar
Tidsramme: Baseline gennem 24 uger

ACR20 Responder Index: Sammensætning af kliniske, laboratoriemæssige og funktionelle målinger af reumatoid arthritis. ACR20 Responder: havde >= 20 % forbedring fra baseline i både 68 ømme og 66 hævede led og >= 20 % forbedring i mindst 3 ud af 5 kriterier: deltagers og læges globale vurdering af sygdomsaktivitet, Health Assessment Questionnaire-Disability Index ( HAQ-DI) (som målte deltagernes oplevede sværhedsgrad ved at udføre daglige aktiviteter), ledsmerter og C-reaktivt protein (CRP). Kaplan-Meier-estimatoren blev brugt til at opsummere tiden til ACR20-respons i løbet af behandlingsperioden (24 uger). Tiden til American College of Rheumatology 20 % (ACR20) respons (i uger) beregnes som:

(Dato for det første postbaseline-besøg i behandlingsperioden, der opfylder ACR20-responskriterier - Dato for første injektion af undersøgelsesbehandling + 1) / 7.
Baseline gennem 24 uger
Sandsynlighed for et ACR20-svar med 24 uger
Tidsramme: Baseline gennem 24 uger

ACR20 Responder Index: Sammensætning af kliniske, laboratoriemæssige og funktionelle målinger af reumatoid arthritis. ACR20 Responder: havde >= 20 % forbedring fra baseline i både 68 ømme og 66 hævede led og >= 20 % forbedring i mindst 3 ud af 5 kriterier: deltagers og læges globale vurdering af sygdomsaktivitet, Health Assessment Questionnaire-Disability Index ( HAQ-DI) (som målte deltagernes oplevede sværhedsgrad ved at udføre daglige aktiviteter), ledsmerter og C-reaktivt protein (CRP). Kaplan-Meier-estimatoren blev brugt til at opsummere tiden til ACR20-respons i løbet af behandlingsperioden (24 uger). Tiden til American College of Rheumatology 20 % (ACR20) respons (i uger) beregnes som:

(Dato for det første postbaseline-besøg i behandlingsperioden, der opfylder ACR20-responskriterier - Dato for første injektion af undersøgelsesbehandling + 1) / 7.
Baseline gennem 24 uger
Procentdel af deltagere med DAS28-baseret European League Against Rheumatism (EULAR) svar
Tidsramme: Op til 24 uger
EULAR Responder-indeks baseret på 28 led-tællinger kategoriserer klinisk respons baseret på forbedring siden baseline i DAS28-CRP. Deltagerne er kategoriseret som EULAR-respondere eller ikke-respondere baseret på forbedring af DAS28-CRP-score fra baseline. EULAR28 responder er defineret som enten DAS28-CRP <=5,1 og DAS28-CRP ændring <-0,6; eller DAS28-CRP >5.1 og DAS28-CRP ændring <-1.2. EULAR28 responder indeks er defineret som god respons: DAS28-CRP <=3,2 og DAS28-CRP ændring <-1,2; moderat respons: DAS28-CRP ændring <-1,2 undtagen tilfælde defineret i god respons; eller DAS28-CRP <=5,1 og DAS28-CRP ændring <-0,6 og >-1,2. EULAR-remission er defineret som en DAS28-CRP-score på <2,6.
Op til 24 uger
Ændring fra baseline til 24 uger i medicinske resultater Undersøgelse 36-Item Short Form (SF-36) Sundhedsstatusundersøgelse Domæne og oversigtsresultater
Tidsramme: Baseline, op til 24 uger
SF-36 er en sundhedsrelateret undersøgelse, der vurderer deltagerens livskvalitet og består af 36 spørgsmål, der dækker 8 sundhedsdomæner: fysisk funktion, kropslige smerter, rollebegrænsninger på grund af fysiske problemer og følelsesmæssige problemer, generel sundhed, mental sundhed, social funktion. , vitalitet og 2 komponentscores (mental [MCS] og fysisk sundhed [PCS]). Domænescore beregnet ved at summere hvert element for hvert domæne og transformere score til 0-100 skalaen; højere score indikerede bedre helbredstilstand. MCS-score bestod af social funktion, vitalitet, mental sundhed og rolle-emotionelle skalaer. PCS-score bestod af fysisk funktion, kropslige smerter, rolle-fysiske og generelle sundhedsskalaer. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og DMARD-baggrund som faste faktorer og baseline som en kovariat.
Baseline, op til 24 uger
Ændring fra baseline i C-reaktivt protein (CRP) op til uge 24 endepunkt
Tidsramme: Baseline, op til 24 uger
CRP er en indikator for betændelse. En negativ ændring indikerede en forbedring af deltagerens tilstand. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og DMARD-baggrund som faste faktorer og baseline som en kovariat.
Baseline, op til 24 uger
Skift fra baseline til 24 uger i absolut CD3-CD20+ B-celleantal
Tidsramme: Baseline, op til 24 uger
Celleoverflademarkørklyngebetegnelse (CD) 3 negativ, CD20 positiv (CD3-CD20+) definerer totale modne B-celler. B-lymfocytantigen CD20 er et aktiveret-glykosyleret phosphoprotein udtrykt på overfladen af ​​alle modne B-celler. Baseline B-celleantal bestemmes ved at beregne gennemsnittet af de 2 B-celleantal før behandling opnået én gang i løbet af dag -28 til -7 og på dag 0. En positiv eller negativ ændring indikerede henholdsvis en stigning eller et fald i B-celleantal . LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og DMARD-baggrund som faste faktorer og baseline som en kovariat.
Baseline, op til 24 uger
Ændring fra baseline til 24 uger i serumimmunoglobulin (Ig) niveauer
Tidsramme: Baseline, op til 24 uger
Immunglobuliner, eller antistoffer, er store proteiner, der bruges af immunsystemet til at identificere og neutralisere fremmede partikler såsom bakterier og vira. Deres normale blodniveauer indikerer korrekt immunstatus. Ændring fra baseline serumimmunoglobulin G (IgG), immunglobulin A (IgA) og immunglobulin M (IgM) niveauer er rapporteret. En negativ ændring indikerede et fald i immunoglobulinniveauer. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region, tumornekrosefaktor-utilstrækkelig responderbehandlingshistorie og DMARD-baggrund som faste faktorer og baseline som en kovariat.
Baseline, op til 24 uger
Populationsfarmakokinetik (PK)
Tidsramme: Baseline gennem 24 uger
Populationsestimat af konstant clearance som bestemt ved populationsfarmakokinetik (PK) analyse. En 2-rumsmodel blev brugt i PK-modellering.
Baseline gennem 24 uger
Procentdel af deltagere, der udvikler anti-LY2127399 antistoffer
Tidsramme: Baseline gennem 24 uger
LY2127399 anti-lægemiddel-antistoffer (ADA) blev vurderet ved baseline, 1, 4, 16 og 24 uger. Procentdel af deltagere (Pts) med ADA=(antal Pts med behandlingsudløst ADA/antal Pts vurderet)*100. Pts med behandlings-emergent ADA var Pts, der havde en hvilken som helst prøve fra baseline op til og gennem uge 24, der var en 4-fold stigning (2-fortyndingsstigning) i immunogenicitetstiter over baseline titer, eller Pts, der testede negativ ved baseline og positiv post -basislinje (ved titer på ≥1:20).
Baseline gennem 24 uger

Samarbejdspartnere og efterforskere

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

Sponsor

Eli Lilly and Company

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. januar 2011

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først indsendt

14. september 2010

Først indsendt, der opfyldte QC-kriterier

14. september 2010

Først opslået (Skøn)

16. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. marts 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

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 .

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