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En undersøgelse af deltagere med reumatoid arthritis (FLEX V)

11. maj 2018 opdateret af: Eli Lilly and Company

En fase 3, multicenter, randomiseret, dobbeltblind, placebokontrolleret undersøgelse til evaluering af effektiviteten og sikkerheden af ​​LY2127399 hos patienter med moderat til svær leddegigt (RA), som havde en utilstrækkelig respons på en eller flere TNF-α-hæmmere (FLEX) V)

Det primære formål med denne undersøgelse er at hjælpe med at besvare, om LY2127399 er sikker og effektiv til behandling af leddegigt hos deltagere med et utilstrækkeligt respons på en eller flere tumornekrosefaktor-alfa (TNF-α)-hæmmere.

Denne undersøgelse består af 2 perioder:

Periode 1: 24 ugers blindbehandling

Periode 2: 48 ugers opfølgning efter behandling

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

456

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.
      • Lujan, Argentina, 6700
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, B1878DVC
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Isidro, Argentina, B1642AKG
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
  • Brasilien
      • Campinas, Brasilien, 13059-000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Juiz De Fora, Brasilien, 36010-570
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
  • 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
      • Kazan, Den Russiske Føderation, 420029
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Khanty-Mansiysk, Den Russiske Føderation, 628012
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 115093
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Petrozavodsk, Den Russiske Føderation, 185019
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 191104
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Voronezh, Den Russiske Føderation, 394066
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Huntsville, Alabama, Forenede Stater, 35810
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • 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.
    • Arkansas
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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
      • Escondido, California, Forenede Stater, 92027
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Fresno, California, Forenede Stater, 93720
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hemet, California, Forenede Stater, 92543
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Huntington Beach, California, Forenede Stater, 92646
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • La Mesa, California, Forenede Stater, 91942
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Loma Linda, California, Forenede Stater, 92354
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Long Beach, California, Forenede Stater, 90808
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Los Angeles, California, Forenede Stater, 90022
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Diego, California, Forenede Stater, 92108
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Santa Monica, California, Forenede Stater, 90404
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • 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.
      • 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.
      • Denver, Colorado, Forenede Stater, 80209
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Boca Raton, Florida, Forenede Stater, 33486
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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.
      • 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.
      • Miami, Florida, Forenede Stater, 33173
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • New Port Richey, Florida, Forenede Stater, 34652
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • 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.
      • Tampa, Florida, Forenede Stater, 33609
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Vero Beach, Florida, Forenede Stater, 32960
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • West Palm Beach, Florida, Forenede Stater, 33401
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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.
      • Dunwoody, Georgia, Forenede Stater, 30338
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • 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.
      • Stockbridge, Georgia, Forenede Stater, 30281
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Illinois
      • Peoria, Illinois, Forenede Stater, 61636
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rock Island, Illinois, Forenede Stater, 61201
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Indiana
      • Brownsburg, Indiana, Forenede Stater, 46112
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Evansville, Indiana, Forenede Stater, 47714
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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
      • Kansas City, Kansas, Forenede Stater, 66160
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Kentucky
      • Bowling Green, Kentucky, Forenede Stater, 42101
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lexington, Kentucky, Forenede Stater, 40504
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Owensboro, Kentucky, Forenede Stater, 42303
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Louisiana
      • Monroe, Louisiana, Forenede Stater, 71203
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Maryland
      • Wheaton, Maryland, Forenede Stater, 20902
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Massachusetts
      • Haverhill, Massachusetts, Forenede Stater, 01830
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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
      • 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.
    • Minnesota
      • Edina, Minnesota, Forenede Stater, 55435
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Florissant, Missouri, Forenede Stater, 63031
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saint 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.
    • Montana
      • Kalispell, Montana, Forenede Stater, 59901
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 89128
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Hampshire
      • Nashua, New Hampshire, Forenede Stater, 03060
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Jersey
      • Berkeley Heights, New Jersey, Forenede Stater, 07922
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Clifton, New Jersey, Forenede Stater, 07012
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
    • 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.
      • Greensboro, North Carolina, Forenede Stater, 27408
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Sanford, North Carolina, Forenede Stater, 27330
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58502
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Cleveland, Ohio, Forenede Stater, 44109
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 73104
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 74104
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Erie, Pennsylvania, Forenede Stater, 16508
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Wexford, Pennsylvania, Forenede Stater, 15090
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 29651
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Taylors, South Carolina, Forenede Stater, 29687
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Houston, Texas, Forenede Stater, 77008
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • 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.
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Danville, Virginia, Forenede Stater, 24541
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Richmond, Virginia, Forenede Stater, 23225
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Tacoma, Washington, Forenede Stater, 98405
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wenatchee, Washington, Forenede Stater, 98801
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Racine, Wisconsin, Forenede Stater, 53406
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Frankrig
      • Montpellier, Frankrig, 34295
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nice, Frankrig, 06202
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Orleans, Frankrig, 45000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Paris, Frankrig, 75018
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saint-Etienne Cedex 02, Frankrig, 42055
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Strasbourg, Frankrig, 67 098
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Toulouse, Frankrig, 31059
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Grækenland
      • Haidari/Athens, Grækenland, 12462
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Larissa, Grækenland, 411 10
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Thessaloniki, Grækenland, 54642
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Italien
      • Arenzano, Italien, 16011
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Japan
      • Fukuoka, Japan, 807-8555
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Hyogo, Japan, 673-1462
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kanagawa, Japan, 216-8511
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Miyazaki, Japan, 880-0122
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nagasaki, Japan, 852-8501
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Okayama, Japan, 700-8558
        • 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, 162
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Korea, Republikken
      • Incheon, Korea, Republikken, 400-711
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul, Korea, Republikken, 150-713
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Suwon-City, Korea, Republikken, 442-721
        • 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.
  • Malaysia
      • 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.
      • Putrajaya, Malaysia, 62250
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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
      • 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.
      • Col Centro, Mexico, 80000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Guadalajara, Mexico, 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.
      • Mexico City, Mexico, 03720
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • 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.
      • 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.
      • 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.
      • Plock, Polen, 09-400
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 02-118
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Spanien
      • Barcelona, Spanien, 08034
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bilboa, Spanien, 48013
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      • La Coruña, Spanien, 15006
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      • Madrid, Spanien, 28046
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      • Manises, Spanien, 46940
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      • Santiago De Compostela, Spanien, 15706
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  • Sydafrika
      • Benoni, Sydafrika, 1500
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      • Bloemfontein, Sydafrika, 9301
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      • Limpopo, Sydafrika, 0380
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  • Taiwan
      • Keelung, Taiwan, 204
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taichung, Taiwan, 40705
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      • 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.
  • Tyskland
      • Bad Doberan, Tyskland, 18209
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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.
      • Baden-Baden, Tyskland, 76530
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Berlin, Tyskland, 14059
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Dresden, Tyskland, 01307
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Erlangen, Tyskland, 91054
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Frankfurt, Tyskland, 60590
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Göttingen, Tyskland, 37075
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Koeln, Tyskland, 50924
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Munich, Tyskland, 80639
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 RA på mere end 6 måneder og mindre end 15 år
  • Mindst 8 ømme og hævede led
  • Et unormalt højt niveau af C-reaktivt protein (CRP) eller erytrocytsedimentationshastighed (ESR)
  • Positiv for reumatoid faktor (RF) eller anti-cyklisk citrullineret peptid (CCP) antistof
  • Tidligere behandlet med biologisk TNF-α-hæmmerbehandling (infliximab, certolizumab, golimumab, etanercept, adalimumab) og stoppet behandling på grund af utilstrækkelig effekt eller intolerance
  • Regelmæssig brug af mindst 1 konventionelt sygdomsmodificerende anti-reumatisk lægemiddel (DMARD) med en stabil dosis i mindst 8 uger før studiestart
  • Kvinder må ikke være gravid, amme eller blive gravid under undersøgelsen

Ekskluderingskriterier:

  • Brug af ustabile doser af ikke-steroide antiinflammatoriske 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/dag (mg/dag) orale steroider inden for de sidste 6 uger
  • 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 på en led eller anden større operation for mindre end 2 måneder siden, eller planlægger at få lavet ledoperation eller større operation under undersøgelsen
  • 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 modtaget 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 milligram (mg) LY2127399

Gives hver 4. uge (Q4W) i 24 uger. Deltagerne modtager en startdosis på 240 mg, når behandlingen påbegyndes.

I løbet af behandlingsperioden vil deltagerne af blindende formål skiftevis injektioner af LY2127399 og injektioner af placebo hver anden uge (Q2W).

I uge 16 vil respondere modtage 1 injektion af 120 mg LY2127399 og 1 injektion med placebo efterfulgt af 120 mg LY2127399 Q4W i resten af ​​den 24-ugers behandlingsperiode.

I uge 16 vil non-responders (NR) modtage 1 injektion på 90 mg LY2127399 og 1 injektion med placebo efterfulgt af 90 mg LY2127399 Q2W i resten af ​​den 24-ugers behandlingsperiode.
Medicin: LY2127399
Administreret subkutant (SC)
Medicin: Placebo Q4W
Administreret SC
Eksperimentel: 90 mg LY2127399

Givet Q2W i 24 uger. Deltagerne får en startdosis på 180 mg, når behandlingen påbegyndes.

I uge 16 vil både respondere og NR modtage 1 injektion af 90 mg LY2127399 og 1 injektion med placebo efterfulgt af 90 mg LY2127399 Q2W i resten af ​​den 24-ugers behandlingsperiode.
Medicin: LY2127399
Administreret subkutant (SC)
Placebo komparator: Placebo

Givet Q2W i 24 uger. Deltagerne får 2 indsprøjtninger placebo ved påbegyndelse af behandlingen.

I uge 16 vil respondere modtage 2 injektioner med placebo, efterfulgt af 1 injektion med placebo Q2W i resten af ​​den 24-ugers behandlingsperiode.

I uge 16 vil NR modtage en 180 mg startdosis af LY2127399 (2 injektioner á 90 mg), efterfulgt af 90 mg LY2127399 Q2W i resten af ​​den 24-ugers behandlingsperiode.
Medicin: LY2127399
Administreret subkutant (SC)
Medicin: Placebo Q2W
Administreret SC

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere med American College of Rheumatology 20 % (ACR20) svar
Tidsramme: Baseline til og med uge 24
ACR Responder Index: sammensat af kliniske, laboratoriemæssige og funktionelle målinger af reumatoid arthritis (RA). ACR20 Responder: en ≥20 % forbedring fra baseline i både 68 ømme led (TJC) og 66 hævede led (SJC) og en ≥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 NR i uge 16, såvel som alle deltagere, der afbrød undersøgelsesbehandling på et hvilket som helst tidspunkt af en eller anden grund, blev defineret som NR fra det tidspunkt og fremadrettet, inklusive uge 24 endepunkt.
Baseline til og med uge 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Populationsfarmakokinetik (PK): Konstant clearance
Tidsramme: Baseline til og med uge 24
Populationsestimat af konstant clearance som bestemt ved populations-PK-analyse. En 2-rumsmodel blev brugt i PK-modellering. Konstant clearance er PK-parameteren, som beskriver den lineære eliminering af LY2127399 fra serum.
Baseline til og med uge 24
Procentdel af deltagere med American College of Rheumatology 50 % (ACR50) og 70 % (ACR70) svar
Tidsramme: Baseline til og med uge 24
ACR Responder Index: sammensat af kliniske, laboratoriemæssige og funktionelle mål for RA. ACR50 Responder: havde en ≥50 % forbedring fra baseline i både 68 TJC og 66 SJC og en ≥50 % forbedring i mindst 3 ud af 5 kriterier: deltagers (Pt's) og læges globale vurdering af sygdomsaktivitet, HAQ-DI (målte Pts) ' opfattet sværhedsgrad ved at udføre daglige aktiviteter), ledsmerter og CRP. Procentdel af Pt, der opnår ACR50-respons = [antal (antal) af ACR50-respondere / antal behandlede Pt'er]*100. ACR70-responder: havde en ≥70 % forbedring fra baseline i både TJC og SJC og en ≥70 % forbedring i mindst 3 af de samme 5 kriterier for ACR50. Procentdel af Pt'er, der opnår ACR70-respons = (Antal ACR70-respondere / Antal behandlede Pt'er)*100. Alle NR i uge 16, såvel som alle Pts, der afbrød undersøgelsesbehandling på et hvilket som helst tidspunkt af en eller anden grund, blev defineret som NR fra det pågældende tidspunkt og fremadrettet, inklusive uge 24-endepunkt.
Baseline til og med uge 24
American College of Rheumatology Percent Improvement (ACR-N)
Tidsramme: Baseline til og med uge 24
ACR-N er et kontinuerligt mål for kliniske, laboratoriemæssige og funktionelle resultater i RA, der karakteriserer procent (%) af forbedring i sygdomsaktivitet fra baseline baseret på ACR-kernesæt. Dette indeks blev beregnet som minimum af enten a) % ændring i TJC, b) % ændring i SJC eller c) median % ændring af resterende 5 ACR kernekriterier: Hvis ≥3 komponenter af 5 ACR kernekriterierne manglede, så c) var indstillet til at mangle; hvis nogen af ​​3 komponenter a), b) eller c) manglede, blev ACR-N indstillet til manglende. Procentdel af forbedring blev afkortet til intervallet -100 til 100 for at minimere virkningen af ​​outliers (større værdier indikerer større % forbedring), og negative score indikerer et fald. Mindste kvadraters (LS) gennemsnit blev beregnet ved hjælp af analyse af kovarians (ANCOVA) med behandling og region som faste faktorer og baseline Disease Activity Score baseret på 28 ledtællinger -CRP (DAS28-CRP) som en kovariat.
Baseline til og med uge 24
Skift fra baseline til uge 24 i Tender Joint Count (68 Joint Count)
Tidsramme: Baseline, uge ​​24
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 blev oversat til en enkelt øm-versus-ikke-tender-dikotomi. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Skift fra baseline til uge 24 i hævede led (66 led)
Tidsramme: Baseline, uge ​​24
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 og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Ændring fra baseline til uge 24 i deltagerens vurdering af smerte [Visual Analog Scale (VAS)]
Tidsramme: Baseline, uge ​​24
Deltagerens vurdering af deres nuværende gigtsmerter ved hjælp af 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 og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Ændring fra baseline til uge 24 i deltagerens globale vurdering af sygdomsaktivitet (VAS)
Tidsramme: Baseline, uge ​​24
Deltagerens vurdering af deres aktuelle gigtsygdomsaktivitet ved hjælp af VAS varierede fra 0 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 og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Ændring fra baseline til uge 24 i Physician's Global Assessment of Disease Activity (VAS)
Tidsramme: Baseline, uge ​​24
Lægens vurdering af deltagerens aktuelle gigtsygdomsaktivitet ved brug af VAS varierede fra 0 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 og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Ændring fra baseline til uge 24 i Health Assessment Questionnaire-Disability Index (HAQ-DI)
Tidsramme: Baseline, uge ​​24
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 blev beregnet som gennemsnit for at beregne HAQ-DI-score, som varierede fra 0 (ingen handicap) til 3 (alvorligt handicap). Et fald i HAQ-DI-score indikerede en forbedring af deltagerens tilstand. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Ændring fra baseline til uge 24 i sygdomsaktivitetsscore baseret på 28 ledtal og C-reaktivt proteinniveau (DAS28-CRP)
Tidsramme: Baseline, uge ​​24
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), CRP (milligram pr. liter) og deltagerens globale vurdering af sygdom aktivitet ved hjælp af VAS (deltager global VAS). 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 fra 1,0 til 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 og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Procentdel af deltagere med DAS28-CRP-baseret European League Against Rheumatism (EULAR) svar
Tidsramme: Baseline til og med uge 24
EULAR Responder-indeks kategoriserer klinisk respons baseret på forbedring siden baseline i DAS28-CRP. DAS28-CRP=0,56*sqrt(TJC28)+0,28*sqrt(SJC28)+0,36*naturlig log(CRP+1)+0,014*deltager global VAS+0,96. DAS28-CRP-score spænder fra 1,0-9,4, hvor lavere score indikerede mindre sygdomsaktivitet. Høj sygdomsaktivitet: DAS28-CRP >5.1, lav sygdomsaktivitet: DAS28-CRP <3.2 og remission: DAS28-CRP <2.6. Deltagerne er kategoriseret som EULAR-respondere eller NR baseret på forbedring af DAS28-CRP-score fra baseline. EULAR DAS28-CRP responder-indeks definerer en god (absolut: <3,2 eller >1,2 forbedring fra baseline), moderat (absolut: 3,2-5,1 eller 0,6-1,2 forbedring fra baseline), eller ingen respons (absolut: >5,1 eller <0,6 forbedring fra baseline). Procentdel af deltagere med DAS28-CRP baseret EULAR-svar = (antal deltagere med specifikt svar) / (antal deltagere analyseret i gruppen) * 100.
Baseline til og med uge 24
Ændring fra baseline til uge 24 i medicinske resultater undersøgelse 36-item Short Form (SF-36) Health Survey Domain and Summary Scores
Tidsramme: Baseline, uge ​​24
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, 2 komponentscores (CS), fysisk CS (PCS) og mental CS (MCS). Domænescore beregnet ved at summere hvert element for hvert domæne og transformere score til 0-100 skalaen; højere score indikerede bedre helbredstilstand. Hvis < 50 % af spørgsmålene inden for et domæne blev besvaret, blev den rå score ikke beregnet. PCS-score bestod af fysisk funktion, kropslige smerter, rolle-fysiske og generelle sundhedsskalaer. MCS-score bestod af social funktion, vitalitet, mental sundhed og rolle-emotionelle skalaer. Både PCS og MCS varierer fra 0-100 med højere score, der indikerer bedre mental eller fysisk sundhed. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling, region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Ændring fra baseline til uge 24 i kort træthedsopgørelse (BFI) individuelle elementer og effektscore
Tidsramme: Baseline, uge ​​24
BFI er et kort deltagerrapporteret spørgeskema til hurtig vurdering af sværhedsgraden af ​​træthed og træthedens indvirkning på den daglige funktion i de seneste 24 timer. BFI'en indeholder 10 genstande; det første punkt er dog ikke inkluderet i scoringen af ​​skalaen, da det spørger om sædvanlig træthed i løbet af den seneste uge, hvor deltageren har svaret 'ja' eller 'nej'. De resterende 9 punkter vurderer træthedens sværhedsgrad (3 punkter) og indvirkningen af ​​træthed på daglig funktion (6 punkter) ved hjælp af en 11-punkts numerisk skala, med 0 = ingen træthed og 10 = træthed så slemt, som du kan forestille dig. Fatigue impact subscale score er gennemsnittet af de ikke-manglende svar på 6 punkter: generel aktivitet, humør, gangevne, normalt arbejde, relationer til andre mennesker og livsglæde. Hvis mere end 3 punkter inden for træthedspåvirkningsunderskalaen ikke blev besvaret af en deltager, er underskalaen indstillet til manglende. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Skift fra baseline til uge 24 i kort form for smerteopgørelse (BPI-SF) individuelle elementer og interferensresultater
Tidsramme: Baseline, uge ​​24
BPI-SF er en selvrapporteret skala, der måler sværhedsgraden af ​​smerte baseret på den værste smerte, mindste smerte, gennemsnitlig smerte oplevet i løbet af de sidste 24 timer og smerte baseret på smerten lige nu, med scorer fra 0 (ingen smerte ) til 10 (smerte så alvorlige, som du kan forestille dig). Smerteinterferensscore er gennemsnittet af svarene inden for de seneste 24 timer på 7 punkter: generel aktivitet, humør, gangevne, normalt arbejde, relationer til andre mennesker, søvn og livsnydelse [hvert punkt scoret fra 0 (interfererer ikke) ) til 10 (interfererer fuldstændigt)]. Hvis mere end 3 punkter i smerteinterferensresultatet ikke besvares af en deltager, er scoren indstillet til manglende. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Ændring fra baseline til uge 24 i varighed af morgenstivhed (minutter)
Tidsramme: Baseline, uge ​​24
Undersøgeren spørger deltagerne om varigheden af ​​deres morgenstivhed (i minutter) i og omkring leddene og registrerer varigheden. Undersøgeren bør spørge deltagerne om varigheden af ​​morgenstivhed dagen før studiebesøget for at fange faktiske symptomer. Hvis morgenstivhedsvarighed er længere end 12 timer (720 minutter), blev den afkortet til 720 minutter for statistiske præsentationer og analyser. LS-middelværdier blev beregnet ved brug af ANCOVA med behandling og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Tid til ACR20-svar
Tidsramme: Baseline til og med uge 24
Baseline til og med uge 24
Skift fra baseline til uge 24 i absolutte B-celleantal
Tidsramme: Baseline, uge ​​24
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-celletal er gennemsnittet af værdierne på eller før datoen for første injektion af undersøgelsesbehandlingen, inklusive ikke-planlagte besøg. 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 og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Ændring fra baseline til uge 24 i serumimmunoglobulin (Ig) niveauer
Tidsramme: Baseline, uge ​​24
Immunoglobulin (Ig), 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 i serumimmunoglobulin A (IgA), immunglobulin G (IgG) og immunglobulin M (IgM) niveauer er rapporteret. En negativ ændring indikerede et fald i Ig-niveauer. LS-middelværdier blev beregnet ved hjælp af ANCOVA med behandling og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24
Procentdel af deltagere, der udvikler anti-LY2127399 antistoffer
Tidsramme: Baseline til og med uge 24
Deltagere med behandlings-emergent anti-lægemiddel-antistof (ADA) var deltagere, som havde en hvilken som helst prøve fra baseline op til og gennem uge 52, som var en 4-fold stigning (2-fortyndingsstigning) i immunogenicitetstiter over baseline titer, eller deltagere, der testede negativ ved baseline og positiv post-baseline (ved titer på ≥1:20). Procentdel af deltagere med ADA = (antal deltagere med behandlingsudløst ADA) / (antal deltagere vurderet) * 100.
Baseline til og med uge 24
Skift fra baseline til uge 24 i CRP
Tidsramme: Baseline, uge ​​24
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 og region som faste faktorer og baseline som en kovariat.
Baseline, uge ​​24

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. januar 2011

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. januar 2014

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)

14. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 13732
  • H9B-MC-BCDV (Anden identifikator: Eli Lilly and Company)

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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