Um estudo de LY2127399 em participantes com lúpus eritematoso sistêmico
18 de junho de 2018 atualizado por: Eli Lilly and Company
Um estudo de fase 3, multicêntrico, randomizado, duplo-cego, controlado por placebo para avaliar a eficácia e a segurança do LY2127399 subcutâneo em pacientes com lúpus eritematoso sistêmico (LES)
O objetivo deste estudo de LES é avaliar a eficácia, segurança e tolerabilidade de duas doses diferentes de LY2127399 administradas além da terapia padrão de cuidado em participantes com LES ativo.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1124
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Malvern East, Austrália, 3145
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New South Wales
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St Leonards, New South Wales, Austrália, 2065
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Queensland
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Cairns, Queensland, Austrália, 4870
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Maroochydore, Queensland, Austrália, 4558
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Victoria
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Clayton, Victoria, Austrália, 3168
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Heidelberg, Victoria, Austrália, 3081
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Campinas, Brasil, 13015-011
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Goiania, Brasil, 74110-120
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Juiz De Fora, Brasil, 36010-570
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Porto Alegre, Brasil, 91350-200
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Salvador, Brasil, 40050-410
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São Paulo, Brasil, 04039-901
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Ontario
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Hamilton, Ontario, Canadá, L8N 3Z5
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Quebec
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Trois-Rivieres, Quebec, Canadá, G8Z 1Y2
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Cuenca, Equador, EC010150
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Guayaquil, Equador, 90110321
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Quito, Equador, 17
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Barcelona, Espanha, 08035
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Bilbao, Espanha, 48013
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La Coruña, Espanha, 15006
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Las Palmas De Gran Canaria, Espanha, 35010
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Madrid, Espanha, 28040
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Málaga, Espanha, 29010
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Santiago De Compostela, Espanha, 15706
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Sevilla, Espanha, 41071
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Vigo, Espanha, 36200
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Alabama
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Anniston, Alabama, Estados Unidos, 36207
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Birmingham, Alabama, Estados Unidos, 35216
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Arizona
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Gilbert, Arizona, Estados Unidos, 85234
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Scottsdale, Arizona, Estados Unidos, 85258
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Tempe, Arizona, Estados Unidos, 85282
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Arkansas
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Malvern, Arkansas, Estados Unidos, 72104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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California
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Covina, California, Estados Unidos, 91723
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El Cajon, California, Estados Unidos, 92020
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Escondido, California, Estados Unidos, 92027
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La Mesa, California, Estados Unidos, 91941
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Lakewood, California, Estados Unidos, 90712
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Los Alamitos, California, Estados Unidos, 90720
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Los Angeles, California, Estados Unidos, 90095
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Pasadena, California, Estados Unidos, 91107
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Riverside, California, Estados Unidos, 92506
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San Diego, California, Estados Unidos, 92108
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San Gabriel, California, Estados Unidos, 91776
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Santa Barbara, California, Estados Unidos, 93108
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Van Nuys, California, Estados Unidos, 91405
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Westlake Village, California, Estados Unidos, 91361
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Whittier, California, Estados Unidos, 90606
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20060
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Florida
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Aventura, Florida, Estados Unidos, 33180
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DeBary, Florida, Estados Unidos, 32713
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Miami, Florida, Estados Unidos, 33175
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Naples, Florida, Estados Unidos, 34102
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New Port Richey, Florida, Estados Unidos, 34652
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Ormond Beach, Florida, Estados Unidos, 32174
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Pensacola, Florida, Estados Unidos, 32514
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Pinellas Park, Florida, Estados Unidos, 33781
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Plantation, Florida, Estados Unidos, 33324
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South Miami, Florida, Estados Unidos, 33143
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Tampa, Florida, Estados Unidos, 33603
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Vero Beach, Florida, Estados Unidos, 32960
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Georgia
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Atlanta, Georgia, Estados Unidos, 30303
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Duluth, Georgia, Estados Unidos, 30096
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Lithonia, Georgia, Estados Unidos, 30038
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Idaho
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Meridian, Idaho, Estados Unidos, 83642
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
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Rockford, Illinois, Estados Unidos, 61107
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46804
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Granger, Indiana, Estados Unidos, 46530
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Indianapolis, Indiana, Estados Unidos, 46202
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Louisiana
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Monroe, Louisiana, Estados Unidos, 71203
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Maine
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Portland, Maine, Estados Unidos, 04102
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Maryland
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Cumberland, Maryland, Estados Unidos, 21502
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Michigan
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Saint Clair Shores, Michigan, Estados Unidos, 48081
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
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Mississippi
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Hattiesburg, Mississippi, Estados Unidos, 39402
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63117
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89128
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New Hampshire
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Nashua, New Hampshire, Estados Unidos, 03060
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New Jersey
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Freehold, New Jersey, Estados Unidos, 07728
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Voorhees, New Jersey, Estados Unidos, 08043
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New Mexico
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Las Cruces, New Mexico, Estados Unidos, 88011
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New York
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Albany, New York, Estados Unidos, 12206
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Brooklyn, New York, Estados Unidos, 11201
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Manhasset, New York, Estados Unidos, 11030
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New York, New York, Estados Unidos, 10021
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New York, New York, Estados Unidos, 10016
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Plainview, New York, Estados Unidos, 11803
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Roslyn, New York, Estados Unidos, 11576
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
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Charlotte, North Carolina, Estados Unidos, 28204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Raleigh, North Carolina, Estados Unidos, 27617
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Rocky Mount, North Carolina, Estados Unidos, 27804
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 45219
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Cleveland, Ohio, Estados Unidos, 44109
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Toledo, Ohio, Estados Unidos, 43606
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
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Pennsylvania
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Duncansville, Pennsylvania, Estados Unidos, 16635
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Wyomissing, Pennsylvania, Estados Unidos, 19610
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
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Tennessee
-
Cookeville, Tennessee, Estados Unidos, 38501
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Knoxville, Tennessee, Estados Unidos, 37909
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Memphis, Tennessee, Estados Unidos, 38163
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Nashville, Tennessee, Estados Unidos, 37203
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Texas
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Amarillo, Texas, Estados Unidos, 79124
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Austin, Texas, Estados Unidos, 78745
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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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Round Rock, Texas, Estados Unidos, 78665
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 78232
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Victoria, Texas, Estados Unidos, 77901
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Utah
-
Saint George, Utah, Estados Unidos, 84790
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Washington
-
Seattle, Washington, Estados Unidos, 98104
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Spokane, Washington, Estados Unidos, 99204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Virginia
-
Clarksburg, West Virginia, Estados Unidos, 26301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chelyabinsk, Federação Russa, 454076
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Ekaterinburg, Federação Russa, 620012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Federação Russa, 420097
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Federação Russa, 650099
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Federação Russa, 125101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Orenburg, Federação Russa, 460018
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Federação Russa, 197089
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Tomsk, Federação Russa, 634063
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Federação Russa, 150023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Orleans, França, 45000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Strasbourg, França, 67091
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Hungria, 1027
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Hungria, 4032
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gyor, Hungria, 9023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Gyula, Hungria, 5700
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Szeged, Hungria, 6720
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Haifa, Israel, 34362
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Kfar Saba, Israel, 44281
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Petah Tikva, Israel, 49100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Tel Hashomer, Israel, 52651
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Zerifin, Israel, 70300
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Riga, Letônia, 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.
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Kota Kinabalu, Malásia, 88586
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Kuala Lumpur, Malásia, 59100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Guadalajara, México, 44650
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Merida, México, 97130
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Mexico City, México, 06090
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 Luis, México, 78240
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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 Luis Potosi, México, 78200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tijuana, México, 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.
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Hamilton, Nova Zelândia, 3204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Otahuhu, Nova Zelândia, 1640
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Takapuna, Nova Zelândia, 622
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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London, Reino Unido, SE1 7EH
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Cambridgeshire
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Cambridge, Cambridgeshire, Reino Unido, CB2 0QQ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dorset
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Poole, Dorset, Reino Unido, BH15 2JB
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Greater London
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London, Greater London, Reino Unido, 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.
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Kent
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Maidstone, Kent, Reino Unido, ME16 9QQ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Lancashire
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Wigan, Lancashire, Reino Unido, WN6 0LW
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Brasov, Romênia, 500283
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Bucharest, Romênia, 020475
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Cluj-Napoca, Romênia, 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.
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Galati, Romênia, 800587
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Iasi, Romênia, 700656
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Targu Mures, Romênia, 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.
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Belgrade, Sérvia, 11000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Kragujevac, Sérvia, 34000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Niska Banja, Sérvia, 18205
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Novi Sad, Sérvia, 21000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Changhua, Taiwan, 500
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Hualien, Taiwan, 970
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Kaohsiung, Taiwan, 833
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Taichung, Taiwan, 40705
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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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.
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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.
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La Marsa, Tunísia, 2070
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Monastir, Tunísia, 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.
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Sfax, Tunísia, 3029
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Sousse, Tunísia, 4000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tunis, Tunísia, 1008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Tunis Monfleury, Tunísia, 1008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Cape Town, África do Sul, 7925
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Durban, África do Sul, 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.
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Stellenbosch, África do Sul, 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.
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Bangalore, Índia, 560043
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Gujarat, Índia, 380015
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Haryana, Índia, 122001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Índia, 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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Kormangala, Índia, 560034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Pune, Índia, 411007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Trivandrum, Índia, 695011
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (ADULTO, OLDER_ADULT)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Critério de inclusão:
- Diagnóstico clínico de LES conforme definido pelos critérios do American College of Rheumatology (ACR)
- Têm anticorpos antinucleares positivos (ANA)
- Concordar em não engravidar durante o julgamento
- Ter uma pontuação SELENA-SLEDAI de triagem ≥6. (O participante deve estar exibindo ativamente todos os sintomas pontuados na triagem SELENA-SLEDAI no dia da triagem.)
Critério de exclusão:
- Tem doença renal lúpica grave ativa
- Tem sistema nervoso central ativo ou doença neurológica periférica
- Receberam imunoglobulina intravenosa (IVIg) dentro de 180 dias após a randomização
- Tiver infecção ativa ou recente dentro de 30 dias após a triagem
- Tiveram uma infecção grave dentro de 90 dias após a randomização
- Tem evidência ou teste positivo para Hepatite B
- Tem hepatite C
- São positivos para o vírus da imunodeficiência humana (HIV)
- Ter evidência de tuberculose ativa ou latente (TB)
- Presença de anormalidades laboratoriais significativas na triagem
- Tiveram uma malignidade nos últimos 5 anos, exceto para carcinoma cervical in situ ou células basais ou células escamosas epiteliais da pele que foram completamente ressecadas sem recorrência nos 3 anos anteriores à randomização
- Ter recebido mais de 40 mg de prednisona ou equivalente nos últimos 30 dias
- Mudou sua dose de medicamento antimalárico nos últimos 30 dias
- Mudou sua dose de medicamento imunossupressor nos últimos 90 dias
- Já recebeu rituximabe anteriormente
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: TRATAMENTO
- Alocação: RANDOMIZADO
- Modelo Intervencional: PARALELO
- Mascaramento: QUADRUPLICAR
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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PLACEBO_COMPARATOR: Placebo
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Administrado por injeção subcutânea por 52 semanas.
Uma dose de ataque correspondente também será administrada na primeira dose.
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EXPERIMENTAL: LY2127399 a cada 2 semanas
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120mg administrado por injeção subcutânea por 52 semanas.
A dose de ataque de 240 mg será administrada como a primeira dose do medicamento do estudo
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EXPERIMENTAL: LY2127399 a cada 4 semanas
Durante o período de tratamento, para fins de ocultação, os participantes alternarão injeções de LY2127399 e injeções de placebo a cada 2 semanas.
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Administrado por injeção subcutânea por 52 semanas.
120mg administrado por injeção subcutânea por 52 semanas.
A dose de ataque de 240 mg será administrada como a primeira dose do medicamento do estudo
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Porcentagem de participantes que obtiveram uma resposta de índice de resposta ao LES na semana 52
Prazo: 52 semanas
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Porcentagem de participantes com redução ≥ 5 pontos desde o início no escore SELENA SLEDAI e sem piora (aumento de < 0,30 pontos desde o início) no PGA, e nenhum novo escore de domínio de órgão BILAG A ou 2 novos escores de domínio de órgão BILAG B em comparação com o basal . SELENA SLEDAI é calculado a partir de 24 descritores individuais em 9 sistemas de órgãos; 0 indica doença inativa e o escore teórico máximo é 105; pontuações > 20 são raras. PGA é uma escala analógica visual pontuada de 0 a 3 (0=nenhum, 1=leve, 2=moderado, 3=grave). O BILAG usa uma pontuação única para cada um dos 9 domínios de órgãos; varia de grave (A) a nenhuma doença (E). Os participantes que não conseguiram cumprir os requisitos de medicamentos concomitantes permitidos foram considerados não respondedores, assim como os participantes que desistiram ou não tinham dados da Semana 52. |
52 semanas
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mudança da linha de base para 52 semanas no nível de ácido desoxirribonucleico de cadeia dupla (Anti-dsDNA)
Prazo: Linha de base, 52 semanas
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O anti-ácido desoxirribonucléico de cadeia dupla (anti-dsDNA) é um analito de laboratório usado para auxiliar no diagnóstico de LES.
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Linha de base, 52 semanas
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Mudança da linha de base para o ponto final de 52 semanas na pontuação do índice de atividade da doença de lúpus eritematoso sistêmico (SLEDAI2K)
Prazo: Linha de base, 52 semanas
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A pontuação do SLE Disease Activity Index 2000 (SLEDAI-2K) é um índice cumulativo ponderado da atividade da doença lúpica.
SLEDAI-2K é calculado a partir de 24 descritores individuais em 9 sistemas de órgãos; 0 indica doença inativa e o escore teórico máximo é 105.
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Linha de base, 52 semanas
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Tempo para o primeiro surto grave de LES (SFI)
Prazo: Linha de base até 52 semanas
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O SFI usa a pontuação do índice de atividade da doença SELENA-SLEDAI, cenários de atividade da doença, mudanças no tratamento e PGA para definir surtos leves/moderados e graves. O índice leva em consideração a mudança absoluta nos escores totais, sintomas novos ou agravados e aumentos no uso de corticosteróides ou hospitalizações devido à atividade da doença. O tempo até o primeiro surto grave de LES (SFI) (em dias) é calculado como: (Data de início do primeiro surto grave de LES (SFI) - Data de randomização + 1). |
Linha de base até 52 semanas
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Mudança da linha de base para o ponto final de 52 semanas nas pontuações do inventário breve de fadiga (BFI)
Prazo: Linha de base, 52 semanas
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Uma escala relatada pelos participantes que mede a gravidade da fadiga com base na pior fadiga experimentada nas últimas 24 horas.
As pontuações de gravidade variaram de 0 (sem fadiga) a 10 (fadiga tão grave quanto você pode imaginar).
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Linha de base, 52 semanas
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Tempo para o primeiro novo grupo de avaliação de lúpus das ilhas britânicas (BILAG A) ou 2 novos surtos de LES BILAG B
Prazo: Linha de base até 52 semanas
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O instrumento British Isles Lupus Assessment Group (BILAG) avalia a atividade global da doença em 9 domínios de sistemas de órgãos. O flare BILAG é avaliado para cada um dos 9 domínios de órgãos usando as regras de flare do índice BILAG2004; A é uma erupção grave e B é uma erupção moderada. O tempo até a primeira explosão de BILAG A ou duas explosões de BILAG B (em dias) é calculado como: (Data de início da primeira explosão de BILAG A ou duas explosões de BILAG B - Data de randomização + 1). Os dois surtos BILAG B devem ocorrer em domínios diferentes na mesma visita. |
Linha de base até 52 semanas
|
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Porcentagem de participantes com aumento na dose de corticosteróides em 52 semanas
Prazo: 52 semanas
|
Um aumento nos corticosteroides em uma visita foi definido como uma alteração da linha de base superior a 2,5 mg/dia na dose ou prednisona ou equivalente usando a dose diária média de corticosteroides ingeridos desde a consulta agendada anterior.
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52 semanas
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Mudança da linha de base para o ponto final de 52 semanas na pontuação de atividade da doença SELENA-SLEDAI
Prazo: Linha de base, 52 semanas
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Avaliação Nacional de Segurança de Estrogênios no Lúpus Eritematoso - Índice de Atividade da Doença do LES (SELENA-SLEDAI) é um índice cumulativo e ponderado da atividade da doença lúpica.
SELENA-SLEDAI é calculado a partir de 24 descritores individuais em 9 sistemas de órgãos; 0 indica doença inativa e o escore teórico máximo é 105.
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Linha de base, 52 semanas
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Porcentagem de participantes capazes de diminuir a dose de prednisona ou equivalente sem aumento na atividade da doença na semana 52
Prazo: 52 semanas
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Um participante alcança efeitos poupadores de corticosteroides (doença quiescente) se tiver atendido aos seguintes critérios durante as semanas 24 a 52; capaz de diminuir sua dose de prednisona ou equivalente a 7,5 mg/dia ou menos, ter doença quiescente (pontuação BILAG C ou melhor em todos os nove sistemas) e nenhum surto de BILAG A ou B nos três meses anteriores, sem aumento em nenhum dos dois antimaláricos ou imunossupressores durante ou antes da visita.
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52 semanas
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Mudança da linha de base para o ponto final de 52 semanas na avaliação global do médico (PGA)
Prazo: Linha de base, 52 semanas
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PGA é uma avaliação clínica de item único do nível atual de atividade da doença do participante medido em uma escala analítica visual contínua de 100 milímetros (mm) com pontos de referência de 0, 1, 2 e 3 da esquerda para a direita, correspondendo a não, leve , moderada e grave atividade da doença de LES.
As pontuações são apresentadas de 0 a 100.
Nenhuma piora definida como aumento de ≤ 0,30 pontos da linha de base.
|
Linha de base, 52 semanas
|
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Mudança da linha de base para 52 semanas Endpoint Lúpus Qualidade de vida (LupusQOL) Pontuações de domínio
Prazo: Linha de base, 52 semanas
|
O LupusQoL é um questionário de autorrelato de 34 itens, específico para a doença, projetado para medir a qualidade de vida relacionada à saúde (QVRS) de participantes com LES em 8 domínios. As respostas são baseadas em uma escala Likert de 5 pontos, onde 0 ( sempre) a 4 (nunca).
Uma pontuação LupusQoL para cada domínio é relatada em uma escala de 0 a 100, com valores maiores indicando melhor HRQoL.
|
Linha de base, 52 semanas
|
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Porcentagem de participantes sem piora na pontuação da avaliação global do médico (PGA) em 52 semanas
Prazo: 52 semanas
|
A Avaliação Global do Médico (PGA) é uma avaliação clínica de item único do nível atual de atividade da doença do participante, medida em uma escala analítica visual contínua de 100 mm com pontos de referência de 0, 1, 2 e 3 da esquerda para a direita, correspondendo a nenhum , atividade leve, moderada e grave da doença de LES.
As pontuações são apresentadas de 0 a 100. Nenhuma piora definida como aumento de ≤ 0,30 pontos da linha de base.
|
52 semanas
|
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Número de participantes sem novas pontuações de atividade de doença BILAG A e não mais de uma nova BILAG B em comparação com a linha de base
Prazo: Linha de base até 52 semanas
|
O instrumento British Isles Lupus Assessment Group (BILAG) avalia a atividade global da doença em 9 domínios de sistemas de órgãos.
O flare BILAG é avaliado para cada um dos 9 domínios de órgãos usando as regras de flare do índice BILAG2004; A é uma erupção grave e B é uma erupção moderada.
|
Linha de base até 52 semanas
|
|
Porcentagem de participantes que obtiveram uma resposta medida pelo SRI modificado sem BILAG A ou não mais que 1 surtos de domínio de órgão BILAG B em 52 semanas
Prazo: 52 semanas
|
Porcentagem de participantes com uma redução ≥ 5 pontos desde o início no escore SELENA SLEDAI e sem piora (aumento de < 0,30 pontos desde o início) no PGA, e nenhum novo BILAG A ou não mais de 1 novo surto de domínio de órgão BILAG B em comparação com o início . (Desfecho primário modificado para usar o BILAG flare em vez do escore de doença BILAG) SELENA SLEDAI é calculado a partir de 24 descritores individuais em 9 sistemas de órgãos; 0 indica doença inativa e o escore teórico máximo é 105. PGA é uma escala analógica visual pontuada de 0 a 3 (0=nenhum, 1=leve, 2=moderado, 3=grave). A exacerbação de BILAG é avaliada para cada um dos 9 domínios de órgãos; A é uma erupção grave e B é uma erupção moderada. Os participantes que não conseguiram cumprir os requisitos de medicamentos concomitantes permitidos foram considerados não respondedores, assim como os participantes que desistiram ou não tinham dados da Semana 52. |
52 semanas
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Toro-Dominguez D, Martorell-Marugan J, Martinez-Bueno M, Lopez-Dominguez R, Carnero-Montoro E, Barturen G, Goldman D, Petri M, Carmona-Saez P, Alarcon-Riquelme ME. Scoring personalized molecular portraits identify Systemic Lupus Erythematosus subtypes and predict individualized drug responses, symptomatology and disease progression. Brief Bioinform. 2022 Sep 20;23(5):bbac332. doi: 10.1093/bib/bbac332.
- Li Y, Higgs RE, Hoffman RW, Dow ER, Liu X, Petri M, Wallace DJ, Dorner T, Eastwood BJ, Miller BB, Liu Y. A Bayesian gene network reveals insight into the JAK-STAT pathway in systemic lupus erythematosus. PLoS One. 2019 Dec 2;14(12):e0225651. doi: 10.1371/journal.pone.0225651. eCollection 2019.
- Kalunian KC, Urowitz MB, Isenberg D, Merrill JT, Petri M, Furie RA, Morgan-Cox MA, Taha R, Watts S, Silk M, Linnik MD. Clinical trial parameters that influence outcomes in lupus trials that use the systemic lupus erythematosus responder index. Rheumatology (Oxford). 2018 Jan 1;57(1):125-133. doi: 10.1093/rheumatology/kex368.
- Rovin BH, Dooley MA, Radhakrishnan J, Ginzler EM, Forrester TD, Anderson PW. The impact of tabalumab on the kidney in systemic lupus erythematosus: results from two phase 3 randomized, clinical trials. Lupus. 2016 Dec;25(14):1597-1601. doi: 10.1177/0961203316650734. Epub 2016 May 24.
- Hoffman RW, Merrill JT, Alarcon-Riquelme MM, Petri M, Dow ER, Nantz E, Nisenbaum LK, Schroeder KM, Komocsar WJ, Perumal NB, Linnik MD, Airey DC, Liu Y, Rocha GV, Higgs RE. Gene Expression and Pharmacodynamic Changes in 1,760 Systemic Lupus Erythematosus Patients From Two Phase III Trials of BAFF Blockade With Tabalumab. Arthritis Rheumatol. 2017 Mar;69(3):643-654. doi: 10.1002/art.39950.
- Merrill JT, van Vollenhoven RF, Buyon JP, Furie RA, Stohl W, Morgan-Cox M, Dickson C, Anderson PW, Lee C, Berclaz PY, Dorner T. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):332-40. doi: 10.1136/annrheumdis-2015-207654. Epub 2015 Aug 20.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2011
Conclusão Primária (REAL)
1 de agosto de 2014
Conclusão do estudo (REAL)
1 de março de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
17 de setembro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de setembro de 2010
Primeira postagem (ESTIMATIVA)
20 de setembro de 2010
Atualizações de registro de estudo
Última Atualização Postada (REAL)
17 de julho de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de junho de 2018
Última verificação
1 de junho de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 13653
- H9B-MC-BCDT (OUTRO: Eli Lilly and Company)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .