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En undersøgelse i moderat til svær reumatoid arthritis (RA-BEAM)

9. september 2019 opdateret af: Eli Lilly and Company

Et randomiseret, dobbeltblindt, placebo- og aktivt kontrolleret fase 3-studie, der evaluerer effektiviteten og sikkerheden af ​​baricitinib hos patienter med moderat til svær aktiv reumatoid arthritis, som har haft en utilstrækkelig respons på methotrexatterapi

Formålet med denne undersøgelse er at afgøre, om baricitinib er placebo overlegen i behandlingen af ​​deltagere med moderat til svær aktiv reumatoid arthritis (RA), som har haft et utilstrækkeligt respons på methotrexat (MTX) behandling.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1307

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Bahia Blanca, Argentina, B8000HXM
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Buenos Aires, Argentina, CBA 1419
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • 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.
      • 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.
  • 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.
      • Merksem, Belgien, 2170
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y3G8
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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.
    • 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.
      • 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.
      • Toronto, Ontario, Canada, M5T 3L9
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
  • Den Russiske Føderation
      • Korolev, Den Russiske Føderation, 141060
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 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.
      • Saint Petersburg, Den Russiske Føderation, 194291
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saratov, Den Russiske Føderation, 410053
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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
    • England
      • London, England, 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.
    • Greater London
      • London, Greater London, Det Forenede Kongerige, E11 1NR
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
    • Scotland
      • Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZN
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
    • West Yorkshire
      • Bradford, West Yorkshire, Det Forenede Kongerige, BD5 0NA
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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
        • Arizona Arthritis & Rheumatology Research
      • Peoria, Arizona, Forenede Stater, 85381
        • Sun Valley Arthritis Center, LTD
      • Phoenix, Arizona, Forenede Stater, 85023
        • Valley Arthritis Care, LLC
      • Tucson, Arizona, Forenede Stater, 85724
        • University of Boards Regent
    • California
      • Fresno, California, Forenede Stater, 93720
        • Valley Endocrine, Fresno
      • Palm Desert, California, Forenede Stater, 92260
        • Desert Medical Advances
      • Santa Maria, California, Forenede Stater, 93454
        • Pacific Arthritis Center
      • Upland, California, Forenede Stater, 91786
        • Inlande Rheumatology Clinical Trials
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80304
        • Boulder Medical Center
    • Connecticut
      • Danbury, Connecticut, Forenede Stater, 06810
        • Clinical Research Center of CT/NY
      • Trumbull, Connecticut, Forenede Stater, 06611
        • New England Research Associates
    • Delaware
      • Lewes, Delaware, Forenede Stater, 19958
        • Delaware Arthritis
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33472
        • Orthopedic Research Institute
      • Naples, Florida, Forenede Stater, 34102
        • Jeffrey Alper, M.D.
      • New Port Richey, Florida, Forenede Stater, 34652
        • Sun Coast Clinical Research, Inc
      • Orlando, Florida, Forenede Stater, 32806
        • Rheumatology Associates of Central Florida
      • Plantation, Florida, Forenede Stater, 33324
        • Integral Rheumatology & Immunology Specialists
      • Tampa, Florida, Forenede Stater, 33613
        • McIlwain Medical Group
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University Health
      • Indianapolis, Indiana, Forenede Stater, 46227
        • Diagnostic Rheumatology and Research
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Goldpoint Clinical Research LLC
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49546
        • West Michigan Rheumatology
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65212
        • University of Missouri
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Dr. George Timothy Kelly
    • New Jersey
      • Freehold, New Jersey, Forenede Stater, 07728
        • (AOA) Arthritis & Osteoporosis Associates
      • Toms River, New Jersey, Forenede Stater, 08755
        • Bio Behavioral Health
    • New York
      • Hartsdale, New York, Forenede Stater, 10530
        • Drug Trials of America
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28803
        • Asheville Rheumatology & Osteoporosis Research Assoc, PA
    • Ohio
      • Middleburg Heights, Ohio, Forenede Stater, 44130
        • Paramount Medical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • Health Research Institute
      • Tulsa, Oklahoma, Forenede Stater, 74135
        • Healthcare Research Consultant
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forenede Stater, 18017
        • East Penn Rheumatology
      • Wyomissing, Pennsylvania, Forenede Stater, 19610
        • Clinical Research Center of Reading, LLP
    • South Carolina
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
        • Carolina Rheumatology and Neurology Associates
    • Texas
      • Dallas, Texas, Forenede Stater, 75231
        • Metroplex Clinical Research Center
      • Houston, Texas, Forenede Stater, 77008
        • Pioneer Research Solutions
      • Houston, Texas, Forenede Stater, 77084
        • Accurate Clinical Research
      • Lubbock, Texas, Forenede Stater, 79424
        • Arthritis & Osteoporosis Associates LLP
      • Nassau Bay, Texas, Forenede Stater, 77058
        • Accurate Clinical Research
      • Webster, Texas, Forenede Stater, 77508
        • Accurate Clinical Research
    • Virginia
      • Chesapeake, Virginia, Forenede Stater, 23320
        • Center for Arthritis and Rheumatic Diseases, PC
    • Washington
      • Seattle, Washington, Forenede Stater, 98133
        • The Seattle Arthritis Clinic
      • Vancouver, Washington, Forenede Stater, 98664
        • Vancouver Clinic
    • Wisconsin
      • Franklin, Wisconsin, Forenede Stater, 53132
        • Rheumatology and Immunotherapy Center
  • Frankrig
      • Cahors Cedex 9, Frankrig, 46005
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Limoges, Frankrig, 87042
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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.
      • Nantes, Frankrig, 44093
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Orleans, Frankrig, 45032
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Paris, Frankrig, 75679
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Poitiers, Frankrig, 86021
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Strasbourg, Frankrig, 67098
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Thionville, Frankrig, 57100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tours, Frankrig, 37044
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Grækenland
      • Athens, 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.
      • 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.
      • Marousi, 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.
  • Japan
      • Aichi, Japan, 450-0002
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 814-0002
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hiroshima, Japan, 730-0017
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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.
      • Ibaraki, Japan, 305-8576
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Iwate, Japan, 020-0034
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 211-0063
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kanagawa, Japan, 224-0041
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kumamoto, Japan, 862-8655
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 850-0832
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Niigata, Japan, 957-0054
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Oita, Japan, 870-0823
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Okayama, Japan, 700-0013
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Osaka, Japan, 545-0011
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saga, Japan, 843-0393
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saitama, Japan, 333-0833
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Shizuoka, Japan, 420-0821
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tochigi, Japan, 329- 0498
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Yamaguchi, Japan, 745-0824
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Kina
      • Beijing, Kina, 100044
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bengbu, Kina, 233004
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Changsha, Kina, 410011
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Guang Zhou, Kina, 510630
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hefei, Kina, 230022
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Jinan, Kina, 250012
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Shanghai, Kina, 200052
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wu Han, Kina, 430030
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Korea, Republikken
      • Daegu, Korea, Republikken, 700-712
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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.
      • Gwangju, Korea, Republikken, 510-757
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Incheon, Korea, Republikken, 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, 130-702
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Suwon-Si, Korea, Republikken, 443-721
        • 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.
  • Kroatien
      • Varazdin, Kroatien, 42000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zagreb, Kroatien, 10 000
        • 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.
  • Letland
      • Liepaja, Letland, LV-3401
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Riga, Letland, LV-1002
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valmiera, Letland, LV-4201
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Litauen
      • Kaunas, Litauen, LT-50128
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Klaipeda, Litauen, LT-92288
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Siauliai, Litauen, 76231
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Mexico
      • Guadalajara, Mexico, 44690
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Merida, Mexico, 97070
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mexicali, Mexico, 21200
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mexico, Mexico, 06600
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Tijuana, Mexico, 22010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 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.
      • Gdansk, Polen, 80-546
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Katowice, Polen, 40-084
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lodz, Polen, 90-242
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nadarzyn, Polen, 05-830
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Warszawa, Polen, 02-653
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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
      • Carolina, Puerto Rico, 00983
        • Ramon L. Ortega Colon
      • San German, Puerto Rico, 00683
        • Office of Dr. Ramon Toro
      • San Juan, Puerto Rico, 00918
        • Mindful Medical Research
      • Santurce, Puerto Rico, 00909
        • Latin Clinical Trial Center
  • Rumænien
      • Bucharest, Rumænien, 10584
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cluj-Napoca, Rumænien, 400006
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Constanta, Rumænien, 900591
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lasi, Rumænien, 700661
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Oradea, Rumænien, 410028
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Targu Mures, Rumænien, 540136
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Schweiz
      • Fribourg, Schweiz, 1708
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Slovakiet
      • Bratislava, Slovakiet, 84231
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Partizanske, Slovakiet, 95801
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Spisska Nova Ves, Slovakiet, 052 01
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Topolcany, Slovakiet, 95501
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Slovenien
      • Ljubljana, Slovenien, 1000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Maribor, Slovenien, 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.
  • Spanien
      • Barcelona, Spanien, 08025
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bilbao, Spanien, 48013
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hospitalet De Llobregat, Spanien, 08907
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Madrid, Spanien, 28040
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sabadell, Spanien, 08208
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Santander, Spanien, 39008
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sevilla, Spanien, 41010
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valencia, Spanien, 46026
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Villajoyosa, Spanien, 03570
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Sydafrika
      • Durban, Sydafrika, 4001
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
      • Pinelands, Sydafrika, 7405
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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.
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Neihu Taipei, Taiwan, 114
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taichung, Taiwan, 404
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taichung City, Taiwan, 40201
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Taipei, Taiwan, 10630
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Yongkang City, Taiwan, 71004
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Tjekkiet
      • Brno, Tjekkiet, 61141
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bruntal, Tjekkiet, 79201
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hustopece, Tjekkiet, 693 01
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ostrava, Tjekkiet, 702 00
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ostrava - Trebovice, Tjekkiet, 722 00
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pardubice, Tjekkiet, 530 02
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Prague, Tjekkiet, 128 50
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Uherske Hradiste, Tjekkiet, 686 01
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zlin, Tjekkiet, 760 01
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Tyskland
      • 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.
      • Herne, Tyskland, 44649
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Köln, Tyskland, 50937
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Würzburg, Tyskland, 97080
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Ungarn
      • Budapest, Ungarn, 1023
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kiskunhalas, Ungarn, 6400
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nyiregyhaza, Ungarn, 4400
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Szekesfehervar, Ungarn, 8000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Veszprem, Ungarn, 8200
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Deltagelseskriterier

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

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

  • Har en diagnose af voksendebut Rheumatoid Arthritis (RA) som defineret af American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 Kriterier for klassificering af RA
  • Har moderat til svær aktiv RA defineret som tilstedeværelsen af ​​mindst 6/68 ømme led og mindst 6/66 hævede led
  • Har et C-reaktivt protein (CRP) eller højfølsomt C-reaktivt protein (hsCRP) måling ≥6 milligram pr. liter (mg/L)
  • Har haft regelmæssig brug af methotrexat (MTX) i mindst de 12 uger forud for studiestart i en dosis, der anses for acceptabel til tilstrækkelig vurdering af klinisk respons.
  • Har mindst 1 lederosion i hånd-, håndleds- eller fodled baseret på radiografisk fortolkning af den centrale læser og være positiv med reumatoid faktor eller anticyklisk citrullineret peptid (anti-CCP) antistof; eller har mindst 3 lederosion i hånd-, håndleds- eller fodled baseret på radiografisk fortolkning af den centrale læser uanset reumatoid faktor eller anti-CCP antistofstatus

Ekskluderingskriterier:

  • Modtager i øjeblikket kortikosteroider i doser >10 mg prednison om dagen (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
  • Modtager i øjeblikket samtidig behandling med MTX, hydroxychloroquin og sulfasalazin eller en kombination af 3 konventionelle sygdomsmodificerende antireumatiske lægemidler (cDMARDs)
  • Modtager eller har i øjeblikket modtaget cDMARD'er (f.eks. guldsalte, cyclosporin, azathioprin eller andre immunsuppressiva) bortset fra MTX, hydroxychloroquin (op til 400 mg/dag) eller sulfasalazin (op til 3000 mg/dag) inden for 4 uger før til studieadgang
  • Har fået leflunomid i de 12 uger før studiestart
  • Er påbegyndt en ny fysioterapi behandling for RA i de 2 uger før studiestart
  • Har nogensinde modtaget biologiske sygdomsmodificerende antirheumatiske lægemidler (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 injektion inden for 2 uger før studiestart eller inden for 6 uger før planlagt randomisering eller forventes at kræve 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 nogen tilstand eller kontraindikation for adalimumab, der ville udelukke deltageren fra at deltage i denne protokol
  • Har aktiv fibromyalgi, der 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 sekundær Sjögrens syndrom er ikke udelukket)
  • Har en diagnose af Feltys syndrom
  • Har haft en større operation inden for 8 uger før studiestart eller vil kræve en 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 undersøgelsens start: 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 ringe eller ingen egenomsorg, såsom at være sengeliggende eller begrænset til en kørestol
  • 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, centralnervesysteminvolvering eller 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
Placebo komparator: Placebo

Placebo administreret oralt én gang dagligt gennem uge 24 og placebo administreret ved subkutan (SC) injektion hver 2. uge til og med uge 50.

I uge 24 fik deltagerne baricitinib 4 milligram (mg) oralt én gang dagligt gennem uge 52.

Fra uge 16 blev deltagere, der ikke svarede, reddet med baricitinib 4 mg oralt dagligt til og med uge 52.

Deltagerne fortsatte med at tage baggrundsbehandling med methotrexat (MTX) under hele undersøgelsen.
Medicin: Methotrexat
Indgives oralt
Medicin: Adalimumab Placebo
Adalimumab placebo administreret SC.
Medicin: Baricitinib placebo
Baricitinib placebo indgivet oralt.
Eksperimentel: Baricitinib

Baricitinib 4 mg administreret oralt én gang dagligt gennem uge 52 og en adalimumab placebo SC-injektion hver 2. uge til og med uge 50.

Fra uge 16 fortsatte ikke-responderende deltagere, der oprindeligt var randomiseret til baricitinib, med at modtage baricitinib 4 mg indgivet oralt én gang dagligt gennem uge 52.

Deltagerne fortsatte med at tage baggrundsbehandling med methotrexat (MTX) under hele undersøgelsen.
Medicin: Baricitinib
Indgives oralt
Andre navne:
  • LY 3009104
Medicin: Methotrexat
Indgives oralt
Medicin: Adalimumab Placebo
Adalimumab placebo administreret SC.
Aktiv komparator: Adalimumab

Adalimumab 40 mg indgivet ved subkutan injektion hver 2. uge gennem uge 50 og baricitinib placebo oralt én gang dagligt til og med uge 52.

Fra uge 16 blev deltagere, som ikke svarede, reddet med baricitinib 4 mg oralt én gang dagligt gennem uge 52.

Deltagerne fortsatte med at tage baggrundsbehandling med methotrexat (MTX) under hele undersøgelsen.
Medicin: Adalimumab
Administreret SC
Medicin: Methotrexat
Indgives oralt
Medicin: Baricitinib placebo
Baricitinib placebo indgivet oralt.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere, der opnår American College of Rheumatology 20 % forbedring (ACR20)
Tidsramme: Uge 12
ACR20 Responder Index er en sammensætning af kliniske, laboratoriemæssige og funktionelle målinger i reumatoid arthritis (RA). "ACR20 Responder" er en deltager, som 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 studiet eller lægemidlet eller blev reddet før analysetidspunktet, blev anset for ikke-responderende.
Uge 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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 som målt ved hjælp af mTSS. 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
Ændring fra baseline i Health Assessment Questionnaire-Disability Index (HAQ-DI) score
Tidsramme: Baseline, uge ​​12
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-scoren, som varierede fra 0 (ingen handicap) til 3 (værste handicap). Et fald i HAQ-DI-score indikerede en forbedring af deltagerens tilstand.
Baseline, uge ​​12
Ændring fra baseline i sygdomsaktivitetsscore baseret på et 28 led og højfølsomt C-reaktivt protein (DAS28-hsCRP)
Tidsramme: Baseline, uge ​​12
Disease Activity Score (DAS) modificeret til at omfatte 28 ledtal (DAS28) bestod af sammensat score af følgende variabler: antal ømme led (TJC28), antal hævede led (SJC28), C-reaktivt protein (CRP) (milligram pr. liter), og Patients Global Assessment of Disease Activity ved hjælp af visuel analog skala (VAS) (deltager global VAS). 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 ​​12
Procentdel af deltagere, der opnår American College of Rheumatology 50 % (ACR50) og 70 % (ACR70) svar
Tidsramme: Uge 12, uge ​​24, uge ​​52

ACR50 og ACR70 Responder Index er en sammensætning af kliniske, laboratoriemæssige og funktionelle målinger i RA. ACR50 og ACR70 Responder er en deltager, der har mindst henholdsvis 50 % eller 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 sygdom Aktivitet, 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
Ændring fra baseline i Clinical Disease Activity Index (CDAI)-score
Tidsramme: Baseline, uge ​​12, uge ​​24, 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 ​​12, uge ​​24, uge ​​52
Procentdel af deltagere, der opnår Simplified Disease Activity Index (SDAI)-score ≤3,3
Tidsramme: Uge 12, uge ​​24, uge ​​52
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 12, uge ​​24, uge ​​52
Procentdel af deltagere, der opnår American College of Rheumatology European League Against Rheumatism (ACR/EULAR) remission - Boolean remission
Tidsramme: Uge 12, uge ​​24, uge ​​52
ACR/EULAR-definitionerne af RA-remission inkluderer en boolesk-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
Medianen af ​​individuelle deltageres gennemsnitlige varighed af morgenledsstivhed i de foregående 7 dage, som indsamlet i elektroniske dagbøger
Tidsramme: Uge 12
Deltagerne registrerede varigheden af ​​deres morgenledstivhed (MJS) i timer og minutter i elektroniske dagbøger dagligt. Hvis morgenledsstivheden var længere end 12 timer (720 minutter), blev den afkortet til 720 minutter til statistiske præsentationer og analyser. Den gennemsnitlige værdi for de 7 dage forud for hvert besøg blev beregnet. Et fald i varigheden af ​​morgenledsstivhed indikerede en forbedring af deltagerens tilstand.
Uge 12
Gennemsnitlig sværhedsgrad af morgenledstivhed Numerisk vurderingsskala (NRS) i de foregående 7 dage som indsamlet i elektroniske dagbøger
Tidsramme: Uge 12
Deltagerne vurderede sværhedsgraden af ​​deres morgenledstivhed ved at vælge et tal fra 0 til 10, der bedst beskrev deres overordnede niveau af morgenledstivhed fra det tidspunkt, hvor de vågnede, hvor 0 repræsenterer "ingen ledstivhed" og 10 repræsenterer "ledstivhed som slem". som du kan forestille dig". Deltagerne rapporterede deres sværhedsgrad dagligt i elektroniske dagbøger. Den gennemsnitlige værdi for de 7 dage forud for hvert besøg blev beregnet.
Uge 12
Gennemsnitlig værste træthed Numerisk vurderingsskala (NRS) i de foregående 7 dage som indsamlet i elektroniske dagbøger
Tidsramme: Uge 12
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". Deltagerne rapporterede deres værste træthed i elektroniske dagbøger. Den gennemsnitlige værdi for de 7 dage forud for hvert besøg beregnes.
Uge 12
Gennemsnitlig værste ledsmerter NRS i de foregående 7 dage som indsamlet i elektroniske dagbøger
Tidsramme: Uge 12
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". Deltagerne rapporterede deres værste ledsmerter i daglige elektroniske dagbøger. Den gennemsnitlige værdi for de 7 dage forud for hvert besøg blev beregnet.
Uge 12
Ændring fra baseline i funktionel vurdering af kronisk sygdomsterapi-træthed (FACIT-F) skalaresultater
Tidsramme: Baseline, uge ​​12, uge ​​24, uge ​​52
Den funktionelle vurdering af kronisk sygdomsterapi-træthed (FACIT-F) skalaen er et kort 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 ​​12, uge ​​24, uge ​​52
Ændring fra baseline i Mental Component Score (MCS), Physical Component Score (PCS) i Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
Tidsramme: Baseline, uge ​​12, uge ​​24, 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 (mental [MCS] og fysisk [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 ​​12, uge ​​24, uge ​​52
Ændring fra baseline i European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) resultater
Tidsramme: Baseline, uge ​​12, uge ​​24, 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 ​​12, uge ​​24, uge ​​52
Ændring fra baseline i European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (selvopfattet sundhed)
Tidsramme: Baseline, uge ​​12, uge ​​24, 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 ​​12, uge ​​24, uge ​​52
Ændring fra baseline i resultater for arbejdsproduktivitet og aktivitetsnedsættelse - reumatoid arthritis (WPAI-RA)
Tidsramme: Baseline, uge ​​12, uge ​​24, 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 er opgjort 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 ​​12, uge ​​24, uge ​​52
Ændring fra baseline i Joint Space Narrowing (JSN) og knogleerosionsscore
Tidsramme: Baseline, uge ​​24, 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 erosionens sværhedsgrad 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, 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 12; Uge 24; Uge 32: Præ-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 12; Uge 24; Uge 32: Præ-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 12; Uge 24; Uge 32: Præ-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 12; Uge 24; Uge 32: Præ-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. oktober 2012

Primær færdiggørelse (Faktiske)

1. marts 2015

Studieafslutning (Faktiske)

1. september 2015

Datoer for studieregistrering

Først indsendt

17. oktober 2012

Først indsendt, der opfyldte QC-kriterier

17. oktober 2012

Først opslået (Skøn)

19. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. 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

  • 13978
  • I4V-MC-JADV (Anden identifikator: Eli Lilly and Company)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserede individuelle data på patientniveau vil blive leveret i et sikkert adgangsmiljø efter godkendelse af et forskningsforslag og en underskrevet datadelingsaftale.

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.

IPD-delingsadgangskriterier

Et forskningsforslag skal godkendes af et uafhængigt bedømmelsespanel, og forskere skal underskrive en datadelingsaftale.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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