A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate (FLEX M)
4 de mayo de 2018 actualizado por: Eli Lilly and Company
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate Therapy (FLEX M)
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate.
This study is comprised of 3 periods:
Period 1: 52-week blinded treatment
Period 2: additional 48-week unblinded treatment
Period 3: 48-week post-treatment follow-up
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
1041
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Buenos Aires, Argentina, C1280AEB
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Córdoba, Argentina, X5016KEH
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Lujan, Argentina, 6700
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Mar Del Plata, Argentina, B7600FZN
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Quilmes, Argentina, B1878DVC
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San Juan, Argentina, 5400
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Tucuman, Argentina, 4000
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Malvern East, Australia, 3145
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New South Wales
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Campbelltown, New South Wales, Australia, 2560
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Queensland
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Herston, Queensland, Australia, 4029
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Campinas, Brasil, 13059-000
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Caxias Do Sul, Brasil, 95070-560
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Curitiba, Brasil, 80060-240
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Fortaleza, Brasil, 60150-170
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Goiania, Brasil, 74110-120
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Juiz De Fora, Brasil, 36010-570
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Rio De Janeiro, Brasil, 20551-030
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São Paulo, Brasil, 09090780
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Burgas, Bulgaria, 8000
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4003
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Rousse, Bulgaria, 7002
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Sevlievo, Bulgaria, 5400
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Sofia, Bulgaria, 1784
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Varna, Bulgaria, 9000
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Bogota, Colombia
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Medellin, Colombia
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Busan, Corea, república de, 602-715
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Daegu, Corea, república de, 700-721
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Daejeon, Corea, república de, 301-721
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Incheon, Corea, república de, 400-711
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Seongnam-Si, Corea, república de, 463-707
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Seoul, Corea, república de, 143-729
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Suwon-City, Corea, república de, 442-721
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Opatija, Croacia, 51410
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Osijek, Croacia, 31000
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Rijeka, Croacia, 51 000
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Bratislava, Eslovaquia, 84231
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Dunajska Streda, Eslovaquia, 929 01
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Piestany, Eslovaquia, 921 12
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Alabama
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Birmingham, Alabama, Estados Unidos, 35216
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Huntsville, Alabama, Estados Unidos, 35801
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Arizona
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Paradise Valley, Arizona, Estados Unidos, 85253
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Peoria, Arizona, Estados Unidos, 85381
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Phoenix, Arizona, Estados Unidos, 85018
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Scottsdale, Arizona, Estados Unidos, 85251
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Arkansas
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Hot Springs, Arkansas, Estados Unidos, 71913
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Little Rock, Arkansas, Estados Unidos, 72205
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California
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Escondido, California, Estados Unidos, 92027
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Fresno, California, Estados Unidos, 93720
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Hemet, California, Estados Unidos, 92543
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La Jolla, California, Estados Unidos, 92037
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La Mesa, California, Estados Unidos, 91942
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Sacramento, California, Estados Unidos, 95825
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Torrance, California, Estados Unidos, 90505
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Tustin, California, Estados Unidos, 92780
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Upland, California, Estados Unidos, 91786
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Wildomar, California, Estados Unidos, 92595
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80910
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Denver, Colorado, Estados Unidos, 80209
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Connecticut
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Danbury, Connecticut, Estados Unidos, 06810
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Delaware
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Lewes, Delaware, Estados Unidos, 19958
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Florida
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Aventura, Florida, Estados Unidos, 33180
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Boynton Beach, Florida, Estados Unidos, 33472
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DeBary, Florida, Estados Unidos, 32713
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Palm Harbor, Florida, Estados Unidos, 34684
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Pinellas Park, Florida, Estados Unidos, 33781
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Tampa, Florida, Estados Unidos, 33609
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Venice, Florida, Estados Unidos, 34292
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Vero Beach, Florida, Estados Unidos, 32960
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
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Decatur, Georgia, Estados Unidos, 30033
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Duluth, Georgia, Estados Unidos, 30096
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Gainesville, Georgia, Estados Unidos, 30501
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Marietta, Georgia, Estados Unidos, 30060
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Stockbridge, Georgia, Estados Unidos, 30281
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Idaho
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Eagle, Idaho, Estados Unidos, 83616
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Idaho Falls, Idaho, Estados Unidos, 83404
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Illinois
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Peoria, Illinois, Estados Unidos, 61602
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Indiana
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Evansville, Indiana, Estados Unidos, 47714
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Indianapolis, Indiana, Estados Unidos, 46227
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Kansas
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Shawnee Mission, Kansas, Estados Unidos, 66218
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Kentucky
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Owensboro, Kentucky, Estados Unidos, 42303
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01605
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Michigan
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Bingham Farms, Michigan, Estados Unidos, 48025
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Mississippi
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Flowood, Mississippi, Estados Unidos, 39232
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Jackson, Mississippi, Estados Unidos, 39202
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63141
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68134
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89123
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 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.
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New York
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Brooklyn, New York, Estados Unidos, 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.
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Syracuse, New York, Estados Unidos, 13210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 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.
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Sanford, North Carolina, Estados Unidos, 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.
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Ohio
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Cincinnati, Ohio, Estados Unidos, 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.
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Cleveland, Ohio, Estados Unidos, 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.
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74135
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Erie, Pennsylvania, Estados Unidos, 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.
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Phoenixville, Pennsylvania, Estados Unidos, 19460
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pottstown, Pennsylvania, Estados Unidos, 19464
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29204
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Greenville, South Carolina, Estados Unidos, 29601
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Myrtle Beach, South Carolina, Estados Unidos, 29572
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South Dakota
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Watertown, South Dakota, Estados Unidos, 57201
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38119
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Texas
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Austin, Texas, Estados Unidos, 78731
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Houston, Texas, Estados Unidos, 77090
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Lubbock, Texas, Estados Unidos, 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.
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Mesquite, Texas, Estados Unidos, 75150
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Nassau Bay, Texas, Estados Unidos, 77058
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Richland Hills, Texas, Estados Unidos, 76180
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Antonio, Texas, Estados Unidos, 78215
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Waco, Texas, Estados Unidos, 76708
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wisconsin
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Racine, Wisconsin, Estados Unidos, 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.
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Barnaul, Federación Rusa, 656038
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kazan, Federación Rusa, 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.
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Kemerovo, Federación Rusa, 650066
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Khanty-Mansiysk, Federación Rusa, 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.
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Moscow, Federación Rusa, 125299
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Novosibirsk, Federación Rusa, 630047
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Petrozavodsk, Federación Rusa, 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.
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Ryazan, Federación Rusa, 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.
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Saint Petersburg, Federación Rusa, 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, Federación Rusa, 410002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Stavropol, Federación Rusa, 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.
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Voronezh, Federación Rusa, 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.
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Yaroslavl, Federación Rusa, 150062
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Baja, Hungría, 6500
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Balassagyarmat, Hungría, 2660
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Budapest, Hungría, 1095
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Debrecen, Hungría, 4012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Esztergom, Hungría, 2500
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kiskunhalas, Hungría, 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.
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Satoraljaujhely, Hungría, 3980
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Szikszo, Hungría, 3800
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Veszprem, Hungría, 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.
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Ahmedabad, India, 3800015
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bangalore, India, 5600092
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chennai, India, 600100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hyderabaad, India, 500082
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jaipur, India, 302019
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lucknow, India, 226 014
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mysore, India, 570023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nellore, India, 524003
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Delhi, India, 110 076
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Secunderabad, India, 500 003
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Surat, India, 395003
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Aichi, Japón, 460-0001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chiba, Japón, 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.
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Fukuoka, Japón, 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.
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Gunma, Japón, 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.
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Hokkaido, Japón, 060-8604
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hyogo, Japón, 650-0017
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ibaragi, Japón, 316-0035
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ibaraki, Japón, 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.
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Japan, Japón, 104-8560
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kagoshima, Japón, 891-0133
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kanagawa, Japón, 252-0392
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kumamoto, Japón, 861-8520
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mie, Japón, 514-1101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Miyagi, Japón, 982-0032
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Miyazaki, Japón, 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.
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Nagano, Japón, 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.
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Nagasaki, Japón, 857-1195
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nara, Japón, 634-0007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohita, Japón, 874-0011
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Okayama, Japón, 710-0016
- 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.
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Osaka, Japón, 586-8521
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saga, Japón, 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.
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Saitama, Japón, 337-0012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sapporo-Shi, Japón, 060-8648
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokushima, Japón, 770-8503
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokyo, Japón, 185-0012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toyama, Japón, 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.
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Klaipedos, Lituania, 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.
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Vilnius, Lituania, LT-08661
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kota Bahru, Malasia, 15586
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Perak, Malasia, 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.
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Putrajaya, Malasia, 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.
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Sarawak, Malasia, 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.
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Aguascalientes, México, 20203
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Barrio San Mateo, México, 52140
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Chihuahua, México, 31000
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Guadalajara, México, 44690
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Mexicali, México, 21100
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Mexico City, México, 14050
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Monterrey, México, 64460
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Morelia, México, 58070
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Queretaro, México, 76000
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San Luis Potosi, México, 78200
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Tijuana, México, 22010
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Hamilton, Nueva Zelanda, 3204
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Rotorua, Nueva Zelanda, 3010
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Tauranga, Nueva Zelanda, 3140
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Timaru, Nueva Zelanda
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Bydgoszcz, Polonia, 85-168
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Dzialdowo, Polonia, 13-200
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Elblag, Polonia, 82-300
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Gdynia, Polonia, 81-384
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Lublin, Polonia, 20-607
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Plock, Polonia, 09-400
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Torun, Polonia, 87-100
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Warsaw, Polonia, 01-192
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Wloszczowa, Polonia, 29-100
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Brasov, Rumania, 500365
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Cluj-Napoca, Rumania, 400130
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Iasi, Rumania, 700656
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Ploiesti, Rumania, 100337
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Colombo, Sri Lanka
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Galle, Sri Lanka
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Kalubowila, Sri Lanka
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Nugegoda, Sri Lanka
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Benoni, Sudáfrica, 1500
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Bloemfontein, Sudáfrica, 9301
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Cape Town, Sudáfrica, 7925
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Durban, Sudáfrica, 4001
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Limpopo, Sudáfrica, 0380
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Pretoria, Sudáfrica, 0084
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Somerset West, Sudáfrica, 7130
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Stellenbosch, Sudáfrica, 7600
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Chiayi, Taiwán, 613
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Keelung, Taiwán, 204
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Kuei Shan Hsiang, Taiwán, 33305
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Niao Sung Hsiang, Taiwán, 833
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Taichung, Taiwán, 404
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Taipei, Taiwán, 112
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Dnipropetrovsk, Ucrania, 49008
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Donetsk, Ucrania, 83045
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Kharkiv, Ucrania, 61178
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Kyiv, Ucrania, 03151
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Odesa, Ucrania, 65026
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Poltava, Ucrania, 36038
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Vinnytsya, Ucrania, 21018
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
- Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks
- At least 8 tender and swollen joints
- At least one erosion of a hand or foot joint observed on an X-ray
- An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
- Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody
- Woman must not be pregnant, breastfeeding, or become pregnant during the study
Exclusion Criteria:
- Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6 weeks
- Steroid injection or intravenous (iv) infusion in the last 6 weeks
- Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks
- History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)
- History of a serious reaction to other biological DMARDs
- History of the use of rituximab or other B cell therapy
- Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
- Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)
- Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study
- Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
- Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
- Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
- Hepatitis or human immunodeficiency virus (HIV)
- A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
- Symptoms of herpes zoster or herpes simplex within the last month
- Active or latent tuberculosis (TB)
- Current symptoms of a serious disorder or illness
- Use of an investigational drug within the last month
- History of the use of rituximab, any other B cell targeted biotherapy, or denosumab
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 120 milligrams (mg) LY2127399
Given every 4 weeks (Q4W) for 100 weeks. Participants receive a 240 mg loading dose when initiating treatment. During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Weeks 16 and 52, responders will receive 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 100-week treatment period. At Week 16, non-responders (NR) will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period. |
Administrado por vía subcutánea (SC)
CS administrado
Methotrexate is a background therapy.
|
|
Experimental: 90 mg LY2127399
Given Q2W for 100 weeks. Participants receive a 180 mg loading dose when initiating treatment. At Weeks 16 and 52, responders will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q4W for the rest of the 100-week treatment period. At Week 16, NR will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period. |
Administrado por vía subcutánea (SC)
Methotrexate is a background therapy.
|
|
Comparador de placebos: Placebo
Given Q2W for 52 weeks. At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 52 weeks. At Week 52, responders are randomized to receive 1 of the 2 doses of LY2127399, with loading dose of 240 mg or 180 mg of LY2127399, followed by 120 mg of LY2127399 Q4W or 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period. At Week 16, NR will receive a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period. |
Administrado por vía subcutánea (SC)
CS administrado
Methotrexate is a background therapy.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24
Periodo de tiempo: Baseline through 24 weeks
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ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA).
ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP).
Percentage of participants achieving ACR20 response=(number of ACR20 responders) / (number of participants treated) * 100.
All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
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Baseline through 24 weeks
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Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)
Periodo de tiempo: Baseline, 52 Weeks
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The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints.
X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation).
Erosions scores (range = 0 to 220 for 44 joints) and narrowing scores (range = 0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]).
Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 52 Weeks
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Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Periodo de tiempo: Baseline, 24 weeks
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The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities.
Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability).
A decrease in HAQ-DI score indicated an improvement in the participant's condition.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
|
Baseline, 24 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
Periodo de tiempo: Baseline through 24 weeks and 52 weeks
|
ACR Responder Index: Composite of clinical, laboratory, and functional measures of RA.
ACR50 Responder: had ≥50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and ≥50% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP.
Percentage of Pt achieving ACR50 response=(number (No.) of ACR50 responders) / (No. of Pts treated) * 100.
ACR70 Responder: had ≥70% improvement from baseline in both TJ and SJ counts and ≥70% improvement in at least 3 of same 5 criteria for ACR50.
Percentage of Pts achieving ACR70 response= (No. of ACR70 responders) / (No. of Pts treated) * 100.
All NR at Week 16 as well as all Pts who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Weeks 24 and 52 endpoints.
|
Baseline through 24 weeks and 52 weeks
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Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
|
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS).
DAS28-CRP=0.56*square
root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural
log(CRP+1)+0.014*participant
global VAS+0.96.
Scores ranged from 1.0-9.4,
where lower scores indicated less disease activity and remission is DAS28-CRP <2.6.
A decrease in DAS28-CRP indicated an improvement in participant's condition.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
|
Baseline, 24 weeks and 52 weeks
|
|
Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response
Periodo de tiempo: Baseline through 24 weeks and 52 weeks
|
EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP.
DAS28-CRP scores range from 1.0-9.4,
where lower scores indicated less disease activity.
High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6.
Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline.
EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2
improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline).
Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) * 100.
|
Baseline through 24 weeks and 52 weeks
|
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Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
|
SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (CS), physical CS (PCS) and mental CS (MCS).
Domain scores were calculated by summing each item for each domain and transforming scores into a 0-100 scale.
Higher scores indicated better health status.
If < 50% of the questions within a domain were answered, raw scores were not calculated.
PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales.
MCS score consisted of social functioning, vitality, mental health, and role-emotional scales.
Both PCS and MCS range from 0-100.
Higher score indicated better mental or physical health.
LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.
|
Baseline, 24 weeks and 52 weeks
|
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Change From Baseline in Brief Fatigue Inventory (BFI) Individual Items and Impact Score
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
|
The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours.
The BFI contains 10 items; however, Item 1 is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'.
The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0=no fatigue and 10=fatigue as bad as you can imagine.
The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life.
If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 24 weeks and 52 weeks
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Change From Baseline in Duration of Morning Stiffness (Minutes)
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
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The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration.
The Investigator should ask the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms.
If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 24 weeks and 52 weeks
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Change From Baseline in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
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The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24-hours and pain based on the pain right now with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine).
Pain interference score is the average of the responses in past 24-hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life [each item scored from 0 (does not interfere) to 10 (completely interferes)].
If more than 3 items of the Pain Interference Score are not answered by a participant, the score were set to missing.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 24 weeks and 52 weeks
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Percentage of Participants With Major Clinical Response (MCR) During 52 Weeks
Periodo de tiempo: Baseline through 52 weeks
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Baseline through 52 weeks
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Percentage of Participants With Change From Baseline in mTSS Less Than or Equal to (≤) 0
Periodo de tiempo: Baseline through 24 weeks
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The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints.
X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation).
Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]).
Percentage of participants = (number of participants with mTSS ≤0 at Week 24) / (total number of participants analyzed in the group) * 100.
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Baseline through 24 weeks
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Change From Baseline to Week 52 in B Cell Subset Counts
Periodo de tiempo: Baseline, 52 weeks
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B cell subset counts are: cluster designation (CD)19+ B cell counts, Immature/transitional [CD19+immunoglobulin D (IgD)-CD27-], Mature naïve (CD19+IgD+CD27-), Non-switched memory (CD19+IgD+CD27+) and Memory (CD19+IgD-CD27+).
A positive or negative change indicated an increase or decrease, respectively in B cell count.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 52 weeks
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Population Pharmacokinetics (PK): Constant Clearance
Periodo de tiempo: Baseline through 52 weeks
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Population estimate of constant clearance as determined by population PK analysis.
A 2-compartment model was used in PK modeling.
Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.
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Baseline through 52 weeks
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Percentage of Participants Developing Anti-LY2127399 Antibodies
Periodo de tiempo: Baseline through 52 weeks
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Participants with treatment-emergent anti-drug antibodies (ADA) were participants who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).
Percentage of participants with ADA=(number of participants with treatment-emergent ADA) / (number of participants assessed) * 100.
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Baseline through 52 weeks
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Percentage of Participants With No Structural Progression at Week 52
Periodo de tiempo: Baseline through 52 weeks
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No structural progression is defined as the change in mTSS from baseline ≤0.
The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints.
X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation).
Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]).
Percentage of participants=(number of participants with mTSS ≤0 at Week 52) / (total number of participants analyzed in the group) * 100.
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Baseline through 52 weeks
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Change From Baseline to Week 24 in mTSS
Periodo de tiempo: Baseline, 24 weeks
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The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints.
X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation).
Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]).
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 24 weeks
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Change From Baseline in Serum Immunoglobulin (Ig) Levels
Periodo de tiempo: Baseline, 52 weeks
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Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses.
Their normal blood levels indicate proper immune status.
Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported.
A negative change indicated a decrease in Ig levels.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 52 weeks
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Change From Baseline in Joint Space Narrowing Score and Bone Erosions Score (Components of mTSS)
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
|
The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints.
X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation).
Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]).
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 24 weeks and 52 weeks
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American College of Rheumatology Percent Improvement (ACR-N)
Periodo de tiempo: Baseline through 24 weeks and 52 weeks
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ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set.
This index was calculated as minimum of either a) % change in TJ count, b) % change in SJ count, or c) the median % change of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing.
Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline DAS28-CRP as a covariate.
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Baseline through 24 weeks and 52 weeks
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Change From Baseline in Tender Joint Count (68 Joint Count)
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
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Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints.
Joints were assessed by pressure and joint manipulation on physical examination.
Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions.
Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 24 weeks and 52 weeks
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Change From Baseline in Swollen Joint Count (66 Joint Count)
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
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Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints.
Joints were classified as either swollen or not swollen.
Swelling was defined as palpable fluctuating synovitis of the joint.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 24 weeks and 52 weeks
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Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
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Participant's assessment of their current arthritis pain using VAS ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain).
A decrease in pain score indicated an improvement in the participant's condition.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 24 weeks and 52 weeks
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Change From Baseline in Participant's Global Assessment of Disease Activity (VAS)
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
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Participant's assessment of their current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis).
A decrease in disease activity score indicated an improvement in the participant's condition.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 24 weeks and 52 weeks
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Change From Baseline in Physician's Global Assessment of Disease Activity (VAS)
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
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Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis).
A decrease in disease activity score indicated an improvement in the participant's condition.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 24 weeks and 52 weeks
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Change From Baseline to Week 52 in HAQ-DI
Periodo de tiempo: Baseline, 52 weeks
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The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities.
Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability).
A decrease in HAQ-DI score indicated an improvement in the participant's condition.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 52 weeks
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Change From Baseline to Week 52 in Absolute B Cell Counts
Periodo de tiempo: Baseline, 52 weeks
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Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells.
B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells.
A positive or negative change indicated an increase or decrease, respectively in B cell count.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 52 weeks
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Percentage of Participants With ACR20 at Week 52
Periodo de tiempo: Baseline through 52 weeks
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ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA).
ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP.
Percentage of participants achieving ACR20 response=(number of ACR20 responders) /( number of participants treated) * 100.
All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 52 endpoint.
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Baseline through 52 weeks
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Time to ACR20 Response
Periodo de tiempo: Baseline through 52 weeks
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ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA).
ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP.
The Kaplan-Meier was used to estimate time to ACR20 response over the Treatment Period (52 weeks).
Time to ACR20 response = (Date of the first post-baseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7. Week 16 NR are counted as responders if they responded prior to Week 16.
Otherwise, they are censored at the date of the Week 16 injection.
All participants ongoing at Week 52 and had not yet responded are censored at the date of the Week 52 visit.
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Baseline through 52 weeks
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Change From Baseline in CRP
Periodo de tiempo: Baseline, 24 weeks and 52 weeks
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CRP is an indicator of inflammation.
A negative change indicated an improvement in the participant's condition.
LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Baseline, 24 weeks and 52 weeks
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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Number of Participants Who Died During Post-Treatment Follow-Up Period
Periodo de tiempo: Discontinuation from study treatment up to 48 weeks during follow-up period
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Discontinuation from study treatment up to 48 weeks during follow-up period
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2010
Finalización primaria (Actual)
1 de diciembre de 2012
Finalización del estudio (Actual)
1 de enero de 2014
Fechas de registro del estudio
Enviado por primera vez
8 de septiembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
8 de septiembre de 2010
Publicado por primera vez (Estimar)
9 de septiembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de mayo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
4 de mayo de 2018
Última verificación
1 de mayo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Enfermedades autoinmunes
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades reumáticas
- Enfermedades del tejido conectivo
- Artritis
- Artritis Reumatoide
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes antirreumáticos
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes dermatológicos
- Agentes de control reproductivo
- Agentes abortivos, no esteroideos
- Agentes abortivos
- Antagonistas del ácido fólico
- Metotrexato
Otros números de identificación del estudio
- 11352
- H9B-MC-BCDM (Otro identificador: Eli Lilly and Company)
- CTRI/2011/07/001870 (Identificador de registro: Clinical Trials Registry India)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre LY2127399
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Eli Lilly and CompanyTerminadoArtritis ReumatoideArgentina, Alemania, India, Corea, república de, Estados Unidos, Hungría, Taiwán, Bulgaria, Francia, Federación Rusa, España, Ucrania, Colombia, México, Polonia, Japón, Croacia, Grecia, Nueva Zelanda, Rumania, Sudáfrica, Australia, Brasil y más
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Eli Lilly and CompanyTerminadoInsuficiencia Renal CrónicaEstados Unidos
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Eli Lilly and CompanyTerminado
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Applied Molecular EvolutionEli Lilly and CompanyTerminadoMieloma múltipleEstados Unidos
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Eli Lilly and CompanyTerminadoArtritis ReumatoideEstados Unidos, Alemania, Taiwán, Francia, Japón, México, Polonia, Federación Rusa, España, Colombia, Argentina, Grecia, Nueva Zelanda, Sudáfrica, Australia, Corea, república de, Brasil, Italia, Malasia
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Eli Lilly and CompanyTerminadoArtritis ReumatoideArgentina, India, Estados Unidos, Hungría, Bulgaria, México, Ucrania, Colombia, Taiwán, Polonia, Japón, Corea, república de, Nueva Zelanda, Rumania, Sudáfrica, Australia, Croacia, Lituania, Malasia, Federación Rusa, Eslovaquia, Sri Lanka
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Eli Lilly and CompanyTerminadoLupus eritematoso sistémico | Enfermedad autoinmune | Enfermedad del tejido conectivoIndia, Estados Unidos, Hungría, Rumania, España, Francia, Taiwán, Federación Rusa, Reino Unido, Australia, Letonia, México, Sudáfrica, Canadá, Israel, Brasil, Serbia, Ecuador, Malasia, Nueva Zelanda, Túnez
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Eli Lilly and CompanyTerminadoLupus eritematoso sistémico | Enfermedad autoinmune | Enfermedad del tejido conectivoEstados Unidos
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Eli Lilly and CompanyTerminado
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Eli Lilly and CompanyTerminadoArtritis ReumatoideEstados Unidos, México, Hungría, India, Argentina, Chile, Ucrania, Australia, Rumania, Alemania, Polonia, Eslovaquia