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En undersøgelse af deltagere med moderat til svær reumatoid arthritis (RA-BEGIN)

9. september 2019 opdateret af: Eli Lilly and Company

Et randomiseret, dobbeltblindt, aktivt kontrolleret, fase 3-studie til evaluering af effektiviteten og sikkerheden af ​​baricitinib (LY3009104) hos patienter med moderat til svær aktiv reumatoid arthritis, som har haft begrænset eller ingen behandling med sygdomsmodificerende antirheumatiske lægemidler

Formålet med denne undersøgelse er at bestemme, om baricitinib-terapi alene er noninferior til methotrexat (MTX)-terapi alene i behandlingen af ​​moderat til svær aktiv leddegigt (RA) hos dem, der har haft begrænset eller ingen behandling med MTX og er naive over for andre konventionelle eller biologiske sygdomsmodificerende antireumatiske lægemidler (DMARD'er).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

588

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, C1128AAF
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Caba, Argentina, C1440AAD
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Córdoba, Argentina, 5000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • La Plata, Argentina, B1902COS
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Quilmes, Argentina, 1878
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 Fernando, Argentina, 1646
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • San Miguel De Tucuman, Argentina, T4000AXL
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
  • Belgien
      • Brussel, Belgien, 1200
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Genk, Belgien, 3600
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gent, Belgien, 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.
      • Liège, Belgien, 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.
      • Mons, Belgien, 7000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Brasilien
      • Curitiba, Brasilien, 80030-110
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Goiania, Brasilien, 74110-120
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • São Paulo, Brasilien, 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.
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5M 0H4
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3P9
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ontario
      • Kitchener, Ontario, Canada, N2M 5N6
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ottawa, Ontario, Canada, K1H 1A2
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • St. Catherines, Ontario, Canada, L2N 7E4
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 115522
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Ulyanovsk, Den Russiske Føderation, 432063
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Yaroslavl, Den Russiske Føderation, 150003
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Det Forenede Kongerige
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0QQ
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Greater London
      • London, Greater London, Det Forenede Kongerige, SE1 9RT
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Hampshire
      • Basingstoke, Hampshire, Det Forenede Kongerige, RG24 9NA
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Hants
      • Southampton, Hants, Det Forenede Kongerige, SO16 6YD
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Tyneside
      • North Shields, Tyneside, Det Forenede Kongerige, NE29 8NH
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Forenede Stater
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85304
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mesa, Arizona, Forenede Stater, 85202
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 85037
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • California
      • El Cajon, California, Forenede Stater, 92020
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lakewood, California, Forenede Stater, 90712
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Palm Desert, California, Forenede Stater, 92260
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Upland, California, Forenede Stater, 91786
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80304
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Connecticut
      • Trumbull, Connecticut, Forenede Stater, 06611
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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
      • Boynton Beach, Florida, Forenede Stater, 33472
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Naples, Florida, Forenede Stater, 34102
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Orlando, Florida, Forenede Stater, 32806
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Plantation, Florida, Forenede Stater, 33324
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tampa, Florida, Forenede Stater, 33614
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
    • Illinois
      • Vernon Hills, Illinois, Forenede Stater, 60061
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 46260
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49546
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lansing, Michigan, Forenede Stater, 48910
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63141
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Jersey
      • Freehold, New Jersey, Forenede Stater, 07728
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Toms River, New Jersey, Forenede Stater, 08755
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 87102
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New York
      • Hartsdale, New York, Forenede Stater, 10530
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ohio
      • Middleburg Heights, Ohio, Forenede Stater, 44130
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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
      • Portland, Oregon, Forenede Stater, 97239
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Pennsylvania
      • Duncansville, Pennsylvania, Forenede Stater, 16635
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wyomissing, Pennsylvania, Forenede Stater, 19610
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Tennessee
      • Jackson, Tennessee, Forenede Stater, 38305
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • 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.
      • Grapevine, Texas, Forenede Stater, 76051
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Houston, Texas, Forenede Stater, 77084
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • 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.
    • Virginia
      • Chesapeake, Virginia, Forenede Stater, 23320
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Washington
      • Kennewick, Washington, Forenede Stater, 99336
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vancouver, Washington, Forenede Stater, 98664
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • West Virginia
      • Clarksburg, West Virginia, Forenede Stater, 26301
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Wisconsin
      • Franklin, Wisconsin, Forenede Stater, 53132
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Grækenland
      • Ampelokipoi, Grækenland, 11527
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Heraklion, Grækenland, 71110
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kifissia, Grækenland, 14561
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Larissa, Grækenland, 41221
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Indien
      • Ahmedabad, Indien, 532004
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Attavar, Mangalore, Indien, 575001
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bangalore, Indien, 560 054
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Belgaum, Indien, 590 010
        • 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.
      • Hyderabaad, Indien, 500072
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Jaipur, Indien, 302006
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kolkata, Indien, 700 020
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lucknow, Indien, 226 014
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mumbai, Indien, 400053
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
  • Italien
      • Firenze, Italien, 50139
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Genova, Italien, 16132
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Milano, Italien, 20157
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Monza, Italien, 20900
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Torino, Italien, 10154
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valeggio Sul Mincio, Italien, 37067
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Japan
      • Aichi, Japan, 466-8560
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Chiba, Japan, 284-0003
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Fukuoka, Japan, 807-8556
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hiroshima, Japan, 733-0032
        • 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.
      • 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, 665-0827
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ibaragi, Japan, 316-0015
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Iwate, Japan, 020-0015
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Japan, Japan, 275-8580
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kagawa, Japan, 761-0793
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kagoshima, Japan, 899-5117
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kanagawa, Japan, 236-0004
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kumamoto, Japan, 861-1196
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mie, Japan, 510-0016
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nagano, Japan, 380-8582
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Niigata, Japan, 940-2085
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Okayama, Japan, 700-8607
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Okinawa, Japan, 901-0243
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saitama, Japan, 359-1111
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Shizuoka, Japan, 430-8558
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tokyo, Japan, 160-8582
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Toyama, Japan, 933-0874
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Korea, Republikken
      • Daejeon, Korea, Republikken, 301-721
        • 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.
      • Incheon, Korea, Republikken, 405-760
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
  • Mexico
      • Guadalajara, Mexico, 44620
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Monterrey, Mexico, 64040
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 78213
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Portugal
      • Lisbon, Portugal, 1050
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Porto, Portugal, 4200-319
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Carolina, Puerto Rico, 00983
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San German, Puerto Rico, 00683
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Juan, Puerto Rico, 00927
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Santurce, Puerto Rico, 00909
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Sverige
      • Göteborg, Sverige, SE 413 45
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Huddinge, Sverige, 141 87
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Malmo, Sverige, SE-20502
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Sydafrika
      • 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.
      • 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.
      • Greenacres, Sydafrika, 6057
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Somerset West, Sydafrika, 7135
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
  • Tyskland
      • Bad Nauheim, Tyskland, 61231
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bayreuth, Tyskland, 95444
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Berlin, Tyskland, 13125
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gommern, Tyskland, 39245
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hamburg, Tyskland, 22081
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Munich, Tyskland, 80336
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Østrig
      • Vienna, Østrig, 1100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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:

  • Har en diagnose af reumatoid arthritis (RA) hos voksne som defineret af American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 Kriterier for klassificering af RA
  • Har dokumenteret anamnese med positiv reumatoid faktor og/eller cyklisk citrullineret peptid (CCP) antistoftest
  • Har moderat til svær aktiv RA defineret som tilstedeværelsen af ​​mindst 6/68 ømme led og mindst 6/66 hævede led
  • Har en C-reaktivt protein (CRP) eller højfølsomt C-reaktivt protein (hsCRP) måling ≥1,2 gange den øvre grænse for normal (ULN)
  • Har haft begrænset eller ingen behandling med methotrexat (MTX)

Ekskluderingskriterier:

  • Har modtaget konventionelle sygdomsmodificerende antireumatiske lægemidler (DMARDs) andre end MTX (f.eks. guldsalte, cyclosporin, leflunomid, azathioprin, hydroxychloroquin, sulfasalazin eller andre immunsuppressiva)
  • Modtager i øjeblikket kortikosteroider i doser >10 mg pr. dag af prednison (eller tilsvarende) eller har fået et ustabilt doseringsregime af kortikosteroider inden for 2 uger efter undersøgelsens start eller inden for 6 uger efter planlagt randomisering
  • Har startet behandling med ikke-steroide antiinflammatoriske lægemidler (NSAID'er) eller har fået et ustabilt doseringsregime af NSAID'er inden for 2 uger efter påbegyndelse af undersøgelsen eller inden for 6 uger efter planlagt randomisering
  • Er påbegyndt en ny fysioterapi behandling for RA i de 2 uger før studiestart
  • Har nogensinde fået nogen biologisk DMARD
  • Har modtaget interferonbehandling inden for 4 uger før studiestart eller forventes at kræve interferonbehandling under undersøgelsen
  • Har modtaget et parenteralt kortikosteroid indgivet ved intramuskulær eller intravenøs (IV) injektion inden for 2 uger før studiestart eller inden for 6 uger før planlagt randomisering eller forventes at kræve en parenteral injektion af kortikosteroider under undersøgelsen
  • Har fået injiceret 3 eller flere led med intraartikulære kortikosteroider eller hyaluronsyre inden for 2 uger før studiestart eller inden for 6 uger før planlagt randomisering
  • Har aktiv fibromyalgi, der efter investigatorens mening ville gøre det vanskeligt at vurdere RA-aktivitet på passende vis i forbindelse med denne undersøgelse
  • Har en diagnose af enhver anden systemisk inflammatorisk tilstand end RA, såsom, men ikke begrænset til, juvenil kronisk arthritis, spondyloarthropati, Crohns sygdom, colitis ulcerosa, psoriasisarthritis, aktiv vaskulitis eller gigt (Deltagere med sekundært Sjogrens syndrom er ikke udelukket. )
  • Har en diagnose af Feltys syndrom
  • Har haft en større operation inden for 8 uger efter undersøgelsens start eller vil kræve større operation under undersøgelsen, som efter investigatorens mening i samråd med Lilly eller dens udpegede ville udgøre en uacceptabel risiko for deltageren
  • Har oplevet et eller flere af følgende inden for 12 uger efter studiestart: myokardieinfarkt, ustabil iskæmisk hjertesygdom, slagtilfælde eller New York Heart Association Stage IV hjertesvigt
  • Har en anamnese eller tilstedeværelse af kardiovaskulære, respiratoriske, lever-, gastrointestinale, endokrine, hæmatologiske, neurologiske eller neuropsykiatriske lidelser eller enhver anden alvorlig og/eller ustabil sygdom, der efter investigatorens mening kan udgøre en risiko ved indtagelse af forsøgsprodukt eller kunne forstyrre fortolkningen af ​​data
  • Er stort set eller helt uarbejdsdygtige og tillader lidt eller ingen selvpleje, såsom at være sengeliggende eller begrænset til en kørestol
  • Har en estimeret glomerulær filtrationshastighed (eGFR) baseret på det seneste tilgængelige serumkreatinin ved hjælp af metoden Modification of Diet in Renal Disease (MDRD) på <40 milliliter pr. minut pr. 1,73 m^2 (mL/min/1,73) m^2)
  • Har en historie med kronisk leversygdom med den seneste tilgængelige aspartataminotransferase (AST) eller alaninaminotransferase (ALT) >1,5 gange ULN eller den seneste tilgængelige totale bilirubin ≥1,5 gange ULN
  • Har en historie med lymfoproliferativ sygdom; eller har tegn eller symptomer, der tyder på mulig lymfoproliferativ sygdom, herunder lymfadenopati eller splenomegali; eller har aktiv primær eller tilbagevendende malign sygdom; eller har været i remission fra klinisk signifikant malignitet i <5 år
  • Har været udsat for en levende vaccine inden for 12 uger før planlagt randomisering eller forventes at have behov for/modtage en levende vaccine i løbet af undersøgelsen (med undtagelse af herpes zoster-vaccination)
  • Har en aktuel eller nylig klinisk alvorlig viral, bakteriel, svampe- eller parasitisk infektion
  • Har haft symptomatisk herpes zoster-infektion inden for 12 uger før studiestart
  • Har en historie med spredt/kompliceret herpes zoster (f.eks. multidermatomal involvering, oftalmisk zoster, centralnervesystem involvering, postherpetisk neuralgi)
  • Er immunkompromitterede og har efter investigators mening en uacceptabel risiko for at deltage i undersøgelsen
  • Har en historie med aktivt hepatitis B-virus (HBV), hepatitis C-virus (HCV) eller humant immundefektvirus (HIV)
  • Har screeningslaboratorietestværdier, herunder thyreoidea-stimulerende hormon (TSH), uden for referenceområdet for befolkningen eller undersøgelsesstedet, som efter investigatorens mening udgør en uacceptabel risiko for deltagerens deltagelse i undersøgelsen
  • Har screenings-elektrokardiogram (EKG) abnormiteter, som efter investigatorens eller sponsorens mening er klinisk signifikante og indikerer en uacceptabel risiko for deltagerens deltagelse i undersøgelsen
  • Har symptomatisk herpes simplex på tidspunktet for studietilmelding
  • Har tegn på aktiv eller latent tuberkulose (TB)

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Baricitinib + MTX
Baricitinib 4 milligram (mg) administreret oralt én gang dagligt til og med uge 52. Deltagerne modtog methotrexat (MTX) oralt en gang om ugen med en dosis på mellem 10 og 20 mg om ugen til og med uge 52. Fra uge 24 blev deltagere, som ikke svarede, reddet med baricitinib 4 mg oralt én gang dagligt og MTX oralt én gang om ugen.
Medicin: Baricitinib
Indgives oralt
Andre navne:
  • LY3009104
Medicin: Methotrexat
Indgives oralt
Medicin: Folsyre
Indgives oralt hver dag
Eksperimentel: Baricitinib
Baricitinib 4 mg administreret oralt én gang dagligt til og med uge 52. Deltagerne modtog MTX placebo oralt én gang om ugen til og med uge 52. Fra uge 24 blev deltagere, som ikke svarede, reddet med baricitinib 4 mg oralt én gang dagligt og MTX oralt én gang om ugen.
Medicin: Baricitinib
Indgives oralt
Andre navne:
  • LY3009104
Medicin: Folsyre
Indgives oralt hver dag
Medicin: MTX placebo
MTX placebo indgivet oralt én gang om ugen.
Aktiv komparator: MTX
MTX indgivet oralt én gang om ugen med dosis varierende fra 10 til 20 mg om ugen til og med uge 52. Deltagerne fik også baricitinib placebo oralt én gang dagligt. Fra uge 24 blev deltagere, som ikke svarede, reddet med baricitinib 4 mg oralt én gang dagligt og MTX oralt én gang om ugen.
Medicin: Methotrexat
Indgives oralt
Medicin: Folsyre
Indgives oralt hver dag
Medicin: Baricitinib placebo
Baricitinib placebo administreret oralt én gang dagligt.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere, der opnår American College of Rheumatology 20 % forbedring (ACR20)
Tidsramme: Uge 24
ACR20 Responder Index er en sammensætning af kliniske, laboratoriemæssige og funktionelle målinger i reumatoid arthritis (RA). "ACR20 Responder" er en deltager, der har mindst 20 % forbedring i både ømme og hævede led og i mindst 3 af følgende 5 kriterier: Lægens globale vurdering af sygdomsaktivitet, patientens globale vurdering af sygdomsaktivitet ved hjælp af visuel analog skala ( VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), smerter på grund af gigt og højfølsomt C-reaktivt protein (hsCRP). Deltagere med manglende svar og deltagere, der afbrød undersøgelsen eller lægemidlet eller blev reddet før analysetidspunktet, blev anset for ikke-responderende.
Uge 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere, der opnår American College of Rheumatology 20 % forbedring (ACR20)
Tidsramme: Uge 52
ACR20 Responder Index er en sammensætning af kliniske, laboratoriemæssige og funktionelle målinger i reumatoid arthritis (RA). "ACR20 Responder" er en deltager, der har mindst 20 % forbedring i både ømme og hævede led og i mindst 3 af følgende 5 kriterier: Lægens globale vurdering af sygdomsaktivitet, patientens globale vurdering af sygdomsaktivitet ved hjælp af visuel analog skala ( VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), smerter på grund af gigt og højfølsomt C-reaktivt protein (hsCRP). Deltagere med manglende svar og deltagere, der afbrød undersøgelsen eller lægemidlet eller blev reddet før analysetidspunktet, blev anset for ikke-responderende.
Uge 52
Ændring fra baseline i Health Assessment Questionnaire-Disability Index (HAQ-DI) score
Tidsramme: Baseline, uge ​​24
HAQ-DI vurderer deltagerens selvopfattelse ud fra sværhedsgraden [0 (uden besvær), 1 (med lidt besvær), 2 (med meget besvær) og 3 (ikke i stand til at gøre)] ved påklædning og pleje, der opstår , spise, gå, hygiejne, række ud, gribe og udføre andre daglige aktiviteter. Score for hvert funktionsområde beregnes som gennemsnit for at beregne HAQ-DI-scoren, som spænder fra 0 (ingen handicap) til 3 (værste handicap). Et fald i HAQ-DI-score indikerer en forbedring af deltagerens tilstand.
Baseline, uge ​​24
Ændring fra baseline i sygdomsaktivitetsscore baseret på et 28-ledstal og højfølsomt C-reaktivt protein (DAS28-hsCRP)
Tidsramme: Baseline, uge ​​24
Disease Activity Score (DAS) modificeret til at omfatte 28 ledtal (DAS28) bestod af en sammensat score af følgende variabler: antal ømme led (TJC28), antal hævede led (SJC28), C-reaktivt protein (CRP) (milligram pr. liter) ), og Patient's Global Assessment of Disease Activity. DAS28 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*Patientens Global VAS+0,96. Score varierede 1,0-9,4, hvor lavere score indikerede mindre sygdomsaktivitet.
Baseline, uge ​​24
Ændring fra baseline i den ændrede samlede skarpe score (mTSS)
Tidsramme: Baseline, uge ​​24

Røntgenbilleder af hænder/håndled og fødder blev bedømt for strukturel progression målt ved hjælp af mTSS (van der Heijde 2000). Denne metodologi kvantificerede omfanget af knogleerosion og ledrumsindsnævring for 44 og 42 led, hvor højere score repræsenterede større skade.

mTSS på et tidspunkt er summen af ​​erosion (interval fra 0 til 280) og JSN (interval fra 0 til 168) for en maksimal score på 448.
Baseline, uge ​​24
Procentdel af deltagere, der opnåede et Simplified Disease Activity Index (SDAI)-score ≤3,3
Tidsramme: Uge 24
SDAI er et værktøj til måling af sygdomsaktivitet i RA, der integrerer TJC28, SJC28, akut faserespons ved hjælp af C-reaktivt protein (milligram pr. liter), Patient's Global Assessment of Disease Activity vha. VAS-centimeter (cm) og Physician's Global Assessment of Disease Aktivitet ved hjælp af VAS (cm). SDAI beregnes ved at summere værdierne af de 5 komponenter. Lavere score indikerede mindre sygdomsaktivitet. En indeksbaseret definition af remission forekommer med en SDAI-score ≤3,3.
Uge 24
Procentdel af deltagere, der opnår American College of Rheumatology 50 % (ACR50) svar
Tidsramme: Uge 12, Uge 24, Uge 52
ACR50 Responder Index er sammensat af kliniske, laboratoriemæssige og funktionelle mål i RA. "ACR50 Responder" er en deltager, der har mindst 50 % forbedring i både ømme og hævede led og i mindst 3 af følgende 5 kriterier: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, smerter på grund af gigt og hsCRP. Deltagere med manglende svar og deltagere, der afbrød undersøgelsen eller lægemidlet eller blev reddet før analysetidspunktet, blev anset for ikke-responderende.
Uge 12, Uge 24, Uge 52
Procentdel af deltagere, der opnår American College of Rheumatology 70 % (ACR70) svar
Tidsramme: Uge 12, Uge 24, Uge 52
ACR70 Responder Index er sammensat af kliniske, laboratoriemæssige og funktionelle målinger i RA. "ACR70 Responder" er en deltager, som har mindst 70 % forbedring i både ømme og hævede led og i mindst 3 af følgende 5 kriterier: Lægens globale vurdering af sygdomsaktivitet, patientens globale vurdering af sygdomsaktivitet, HAQ-DI, smerter på grund af gigt og hsCRP. Deltagere med manglende svar og deltagere, der afbrød studiet eller lægemidlet eller blev reddet før analysetidspunktet, blev anset for ikke-responderende.
Uge 12, Uge 24, Uge 52
Ændring fra baseline i Clinical Disease Activity Index (CDAI)-score
Tidsramme: Baseline, uge ​​24; Baseline, uge ​​52
CDAI er et værktøj til måling af sygdomsaktivitet i RA, der ikke kræver en laboratoriekomponent og blev bedømt af undersøgelsesstedet. Den integrerer TJC28 (scoret 0-28 med højere score, der indikerer højere sygdomsaktivitet), SJC28 (scoret 0-28 med højere score, der indikerer højere sygdomsaktivitet), Patient's Global Assessment of Disease Activity (scoret på en visuel analog skala fra 0-10 cm med højere score, der indikerer højere sygdomsaktivitet), og Physician's Global Assessment of Disease Activity (scoret på en visuel analog skala fra 0-10 cm med højere score, der indikerer højere sygdomsaktivitet). CDAI beregnes ved at summere værdierne af de 4 komponenter. CDAI-score varierer fra 0 til 76; lavere score indikerede lavere sygdomsaktivitet. En negativ ændring fra baseline indikerer bedring i tilstanden.
Baseline, uge ​​24; Baseline, uge ​​52
Ændring fra baseline i sygdomsaktivitetsscore 28-erythrocytsedimentationshastighed (DAS28-ESR)
Tidsramme: Baseline, uge ​​24; Baseline, uge ​​52
DAS28 bestod af en sammensat score af følgende variabler: antal ømme led (TJC28), antal hævede led (SJC28), erytrocytsedimentationshastighed (ESR) (millimeter i timen) og Patient's Global Assessment of Disease Activity. DAS28 blev beregnet ved hjælp af følgende formel: DAS28-ESR=0,56*kvadrat root (sqrt)(TJC28)+0,28*sqrt(SJC28)+0,70*naturlig log(ESR)+0,014*Patientens Global VAS. Score varierede 1,0-9,4, hvor lavere score indikerede mindre sygdomsaktivitet.
Baseline, uge ​​24; Baseline, uge ​​52
Procentdel af deltagere, der opnår American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) remission
Tidsramme: Uge 12, Uge 24, Uge 52
ACR/EULAR-definitionerne af RA-remission inkluderer en "boolsk-baseret definition". Den boolsk-baserede definition af remission opstår, når alle 4 af følgende kriterier er opfyldt ved samme besøg: TJC28 ≤1, SJC28 ≤1, akut faserespons ved hjælp af C-reaktivt protein (milligram pr. deciliter) ≤1, Patient's Global Assessment of Sygdomsaktivitet ved brug af VAS (cm) ≤1.
Uge 12, Uge 24, Uge 52
Ændring fra baseline i ledrumsindsnævring og knogleerosionsscore
Tidsramme: Baseline, uge ​​24; Baseline, uge ​​52
Røntgenbilleder af hænder/håndled og fødder blev vurderet for joint space narrowing (JSN) og knogleerosion. Vurdering af JSN for hver hånd (15 led pr. hånd) og fod (6 led pr. fod), inklusive subluksation, scores fra 0 til 4, hvor 0 indikerer ingen (normal) JSN og 4 indikerer fuldstændig tab af ledplads, knogleankylose eller luxation. JSN-score varierede fra 0-168. En score på 0 indikerer ingen ændring, og højere score repræsenterer en forværring af indsnævring af ledrummet. Knogleerosionsscoren er en oversigt over erosionsgraden i 32 led i hænderne og 12 led i fødderne. Hvert led bedømmes efter det involverede overfladeareal fra 0 til 5 for håndled og 0 til 10 for fodled, hvor 0 indikerer ingen erosion og den højeste score (5 for hånden og 10 for foden) indikerer omfattende tab af knogle fra mere end halvdelen af ​​den artikulerende knogle. Erosionsscorer varierede fra 0 (ingen erosion) til 280 (høj erosion).
Baseline, uge ​​24; Baseline, uge ​​52
Ændring fra baseline i varigheden af ​​morgenledsstivhed
Tidsramme: Baseline, uge ​​52
Deltagerne rapporterede varigheden af ​​deres morgenledstivhed (MJS) i timer og minutter. Deltagerne blev spurgt om deres varighed af morgenledsstivhed dagen før studiebesøget for at fange faktiske symptomer, da deltageren kan have haft en atypisk morgenrutine på studiebesøgsdagen. Hvis morgenledsstivheden var længere end 12 timer (720 minutter), blev den afkortet til 720 minutter til statistiske præsentationer og analyser. Et fald i varigheden af ​​morgenledsstivhed indikerede en forbedring af deltagerens tilstand.
Baseline, uge ​​52
Ændring fra baseline i værste træthed Numeric Rating Scale (NRS)
Tidsramme: Baseline, uge ​​24; Baseline uge 52
Deltagerne vurderede deres træthed ved at vælge et tal fra 0 til 10, der bedst beskrev deres værste træthed i løbet af de sidste 24 timer, hvor 0 repræsenterer "ingen træthed" og 10 repræsenterer "så slemt, som du kan forestille dig".
Baseline, uge ​​24; Baseline uge 52
Ændring fra baseline i værste ledsmerter Numeric Rating Scale (NRS)
Tidsramme: Baseline, uge ​​24; Baseline uge 52
Deltagerne vurderede deres ledsmerter ved at vælge et tal fra 0 til 10, der bedst beskrev deres værste ledsmerter i løbet af de sidste 24 timer, hvor 0 repræsenterer "ingen smerte" og 10 repræsenterer "smerter så slemt, som du kan forestille dig".
Baseline, uge ​​24; Baseline uge 52
Ændring fra baseline i Mental Component Score (MCS) og Physical Component Score (PCS) i Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
Tidsramme: Baseline, uge ​​24; Baseline uge 52
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 (MCS og PCS). MCS bestod af social funktion, vitalitet, mental sundhed og rolle-emotionelle skalaer. PCS bestod af fysisk funktion, kropslige smerter, rolle-fysiske og generelle sundhedsskalaer. Hvert domæne scores ved at summere de individuelle elementer og transformere scorerne til en 0 til 100 skala med højere score, der indikerer bedre sundhedsstatus eller funktion.
Baseline, uge ​​24; Baseline uge 52
Ændring fra baseline i European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) resultater
Tidsramme: Baseline, uge ​​24; Baseline uge 52
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) er et standardiseret mål for deltagerens helbredsstatus. Den ene komponent består af et beskrivende system af respondentens helbred bestående af følgende 5 deltagerrapporterede dimensioner: mobilitet, egenomsorg, sædvanlige aktiviteter, smerte/ubehag og angst/depression. Hver dimension har 5 niveauer: ingen problemer, lette problemer, moderate problemer, alvorlige problemer og ekstreme problemer. Svarene bruges til at udlede sundhedstilstandsindeksscorerne ved hjælp af Storbritanniens (UK) algoritme, med scores fra -0,594 til 1, og USA (USA) algoritme, med scores fra -0,109 til 1. En højere score indikerer bedre helbredstilstand.
Baseline, uge ​​24; Baseline uge 52
Ændring fra baseline i European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (selvopfattet sundhed)
Tidsramme: Baseline, uge ​​24; Baseline uge 52
En anden komponent i EQ-5D-5L er en selvopfattet sundhedsscore, som vurderes ved hjælp af en VAS, der spænder fra 0 til 100 millimeter (mm), hvor 0 angiver det værste helbred, du kan forestille dig, og 100 angiver det bedste helbred, du kan forestille dig. kan forestille sig.
Baseline, uge ​​24; Baseline uge 52
Ændring fra baseline i funktionel vurdering af terapi-træthedsresultater for kronisk sygdom (FACIT-F)
Tidsramme: Baseline, uge ​​24; Baseline uge 52
Den funktionelle vurdering af kronisk sygdomsterapi-træthed (FACIT-F) skalaen er et symptomspecifikt spørgeskema med 13 punkter, der specifikt vurderer deltagerens selvrapporterede sværhedsgrad af træthed og dens indvirkning på daglige aktiviteter og funktion. FACIT-F bruger en numerisk vurderingsskala fra 0 ("Slet ikke") til 4 ("Meget meget") for hvert emne til at vurdere træthed og dens indvirkning i de seneste 7 dage. Samlede scorer varierer fra 0 til 52, hvor højere score indikerer mindre træthed.
Baseline, uge ​​24; Baseline uge 52
Ændring fra baseline i resultater for arbejdsproduktivitet og aktivitetsnedsættelse - reumatoid arthritis (WPAI-RA)
Tidsramme: Baseline, uge ​​24; Baseline uge 52
Spørgeskemaet Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) blev udviklet til at måle effekten af ​​generel sundhed og symptomernes sværhedsgrad på arbejdsproduktiviteten og regelmæssige aktiviteter i de 7 dage forud for besøget. Den indeholder 6 punkter, der dækker overordnet arbejdsproduktivitet (sundhed), overordnet arbejdsproduktivitet (symptom), svækkelse af almindelige aktiviteter (sundhed) og svækkelse af almindelige aktiviteter (symptom). Score opgøres som nedskrivningsprocenter. WPAI-RA giver fire typer af score: Fravær (arbejdstid, der er gået glip af), tilstedeværelse (nedsættelse på arbejdet), tab af arbejdsproduktivitet (generelt nedsat arbejdstid) og aktivitetsnedsættelse.
Baseline, uge ​​24; Baseline uge 52
Populationsfarmakokinetik (PK): Topkoncentration ved steady state (Cmax,ss) af baricitinib
Tidsramme: Uge 0: 15 og 60 minutter efter dosis; Uge 4: 2 til 4 timer efter dosis; Uge 8: 4 til 6 timer efter dosis; Uge 12; Uge 24; Uge 32; Før dosis
Uge 0: 15 og 60 minutter efter dosis; Uge 4: 2 til 4 timer efter dosis; Uge 8: 4 til 6 timer efter dosis; Uge 12; Uge 24; Uge 32; Før dosis
Population PK: Areal under kurven for koncentration versus tid ved et doseringsinterval ved steady state (AUCtau,ss) af Baricitinib
Tidsramme: Uge 0: 15 og 60 minutter efter dosis; Uge 4: 2 til 4 timer efter dosis; Uge 8: 4 til 6 timer efter dosis; Uge 12; Uge 24; Uge 32; Før dosis
Uge 0: 15 og 60 minutter efter dosis; Uge 4: 2 til 4 timer efter dosis; Uge 8: 4 til 6 timer efter dosis; Uge 12; Uge 24; Uge 32; Før dosis

Samarbejdspartnere og efterforskere

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

Sponsor

Eli Lilly and Company

Publikationer og nyttige links

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

Generelle publikationer

Datoer for undersøgelser

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

Studer store datoer

Studiestart

1. november 2012

Primær færdiggørelse (Faktiske)

1. februar 2015

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

18. oktober 2012

Først indsendt, der opfyldte QC-kriterier

18. oktober 2012

Først opslået (Skøn)

22. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14062
  • I4V-MC-JADZ (Anden identifikator: Eli Lilly and Company)

Plan for individuelle deltagerdata (IPD)

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JA

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IPD-delingstidsramme

Data er tilgængelige 6 måneder efter den primære offentliggørelse og godkendelse af den undersøgte indikation i USA og EU, alt efter hvad der er senere. Data vil være tilgængelige på ubestemt tid for anmodning.

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IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

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Kliniske forsøg med Rheumatoid arthritis

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