En studie av LY2127399 hos deltakere med systemisk lupus erythematosus
18. juni 2018 oppdatert av: Eli Lilly and Company
En fase 3, multisenter, randomisert, dobbeltblind, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til subkutan LY2127399 hos pasienter med systemisk lupus erythematosus (SLE)
Formålet med denne SLE-studien er å evaluere effektiviteten, sikkerheten og toleransen til to forskjellige doser av LY2127399 administrert i tillegg til standardbehandling hos deltakere med aktiv SLE.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1124
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Malvern East, Australia, 3145
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New South Wales
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St Leonards, New South Wales, Australia, 2065
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Queensland
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Cairns, Queensland, Australia, 4870
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Maroochydore, Queensland, Australia, 4558
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Victoria
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Clayton, Victoria, Australia, 3168
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Heidelberg, Victoria, Australia, 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, Canada, L8N 3Z5
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Quebec
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Trois-Rivieres, Quebec, Canada, G8Z 1Y2
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Chelyabinsk, Den russiske føderasjonen, 454076
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Ekaterinburg, Den russiske føderasjonen, 620012
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Kazan, Den russiske føderasjonen, 420097
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Kemerovo, Den russiske føderasjonen, 650099
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Moscow, Den russiske føderasjonen, 125101
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Orenburg, Den russiske føderasjonen, 460018
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Saint Petersburg, Den russiske føderasjonen, 197089
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Tomsk, Den russiske føderasjonen, 634063
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Yaroslavl, Den russiske føderasjonen, 150023
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Cuenca, Ecuador, EC010150
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Guayaquil, Ecuador, 90110321
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Quito, Ecuador, 17
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Alabama
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Anniston, Alabama, Forente stater, 36207
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Birmingham, Alabama, Forente stater, 35216
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Arizona
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Gilbert, Arizona, Forente stater, 85234
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Scottsdale, Arizona, Forente stater, 85258
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Tempe, Arizona, Forente stater, 85282
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Arkansas
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Malvern, Arkansas, Forente stater, 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, Forente stater, 91723
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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El Cajon, California, Forente stater, 92020
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Escondido, California, Forente stater, 92027
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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La Mesa, California, Forente stater, 91941
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Lakewood, California, Forente stater, 90712
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Los Alamitos, California, Forente stater, 90720
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Los Angeles, California, Forente stater, 90095
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Pasadena, California, Forente stater, 91107
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Riverside, California, Forente stater, 92506
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San Diego, California, Forente stater, 92108
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San Gabriel, California, Forente stater, 91776
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Santa Barbara, California, Forente stater, 93108
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Van Nuys, California, Forente stater, 91405
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Westlake Village, California, Forente stater, 91361
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Whittier, California, Forente stater, 90606
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Colorado
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Aurora, Colorado, Forente stater, 80045
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District of Columbia
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Washington, District of Columbia, Forente stater, 20060
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Florida
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Aventura, Florida, Forente stater, 33180
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DeBary, Florida, Forente stater, 32713
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Miami, Florida, Forente stater, 33175
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Naples, Florida, Forente stater, 34102
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New Port Richey, Florida, Forente stater, 34652
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Ormond Beach, Florida, Forente stater, 32174
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Pensacola, Florida, Forente stater, 32514
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Pinellas Park, Florida, Forente stater, 33781
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Plantation, Florida, Forente stater, 33324
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South Miami, Florida, Forente stater, 33143
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Tampa, Florida, Forente stater, 33603
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Vero Beach, Florida, Forente stater, 32960
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Georgia
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Atlanta, Georgia, Forente stater, 30303
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Duluth, Georgia, Forente stater, 30096
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Lithonia, Georgia, Forente stater, 30038
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Idaho
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Meridian, Idaho, Forente stater, 83642
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Illinois
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Chicago, Illinois, Forente stater, 60612
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Rockford, Illinois, Forente stater, 61107
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Indiana
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Fort Wayne, Indiana, Forente stater, 46804
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Granger, Indiana, Forente stater, 46530
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Indianapolis, Indiana, Forente stater, 46202
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Louisiana
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Monroe, Louisiana, Forente stater, 71203
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Maine
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Portland, Maine, Forente stater, 04102
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Maryland
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Cumberland, Maryland, Forente stater, 21502
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Michigan
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Saint Clair Shores, Michigan, Forente stater, 48081
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Minnesota
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Duluth, Minnesota, Forente stater, 55805
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Mississippi
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Hattiesburg, Mississippi, Forente stater, 39402
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Missouri
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Saint Louis, Missouri, Forente stater, 63117
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Nevada
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Las Vegas, Nevada, Forente stater, 89128
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New Hampshire
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Nashua, New Hampshire, Forente stater, 03060
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New Jersey
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Freehold, New Jersey, Forente stater, 07728
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Voorhees, New Jersey, Forente stater, 08043
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New Mexico
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Las Cruces, New Mexico, Forente stater, 88011
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New York
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Albany, New York, Forente stater, 12206
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Brooklyn, New York, Forente stater, 11201
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Manhasset, New York, Forente stater, 11030
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, New York, Forente stater, 10021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, New York, Forente stater, 10016
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Plainview, New York, Forente stater, 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, Forente stater, 11576
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Chapel Hill, North Carolina, Forente stater, 27599
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Charlotte, North Carolina, Forente stater, 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, Forente stater, 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, Forente stater, 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, Forente stater, 45219
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Forente stater, 44109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toledo, Ohio, Forente stater, 43606
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Oklahoma City, Oklahoma, Forente stater, 73104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Duncansville, Pennsylvania, Forente stater, 16635
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wyomissing, Pennsylvania, Forente stater, 19610
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Tennessee
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Cookeville, Tennessee, Forente stater, 38501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Knoxville, Tennessee, Forente stater, 37909
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Memphis, Tennessee, Forente stater, 38163
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Nashville, Tennessee, Forente stater, 37203
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Texas
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Amarillo, Texas, Forente stater, 79124
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Austin, Texas, Forente stater, 78745
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Nassau Bay, Texas, Forente stater, 77058
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Round Rock, Texas, Forente stater, 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, Forente stater, 78232
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Victoria, Texas, Forente stater, 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
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Saint George, Utah, Forente stater, 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
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Seattle, Washington, Forente stater, 98104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Spokane, Washington, Forente stater, 99204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Virginia
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Clarksburg, West Virginia, Forente stater, 26301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Orleans, Frankrike, 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, Frankrike, 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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Bangalore, India, 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, India, 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, India, 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, 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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Kormangala, India, 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, India, 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, India, 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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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, Latvia, 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, Malaysia, 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, Malaysia, 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, Mexico, 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, Mexico, 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, Mexico, 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, Mexico, 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, Mexico, 78200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tijuana, Mexico, 22010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hamilton, New Zealand, 3204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Otahuhu, New Zealand, 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, New Zealand, 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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Brasov, Romania, 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, Romania, 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, Romania, 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, Romania, 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, Romania, 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, Romania, 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, Serbia, 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, Serbia, 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, Serbia, 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, Serbia, 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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Barcelona, Spania, 08035
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Bilbao, Spania, 48013
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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La Coruña, Spania, 15006
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Las Palmas De Gran Canaria, Spania, 35010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Madrid, Spania, 28040
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Málaga, Spania, 29010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Santiago De Compostela, Spania, 15706
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Sevilla, Spania, 41071
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Vigo, Spania, 36200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, Storbritannia, 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, Storbritannia, 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, Storbritannia, 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, Storbritannia, 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, Storbritannia, 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, Storbritannia, 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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Cape Town, Sør-Afrika, 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, Sør-Afrika, 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, Sør-Afrika, 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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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, Tunisia, 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, Tunisia, 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, Tunisia, 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, Tunisia, 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, Tunisia, 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, Tunisia, 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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Budapest, Ungarn, 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, Ungarn, 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, Ungarn, 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, Ungarn, 5700
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Szeged, Ungarn, 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (VOKSEN, OLDER_ADULT)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inklusjonskriterier:
- Klinisk diagnose av SLE som definert av American College of Rheumatology (ACR) kriterier
- Har positive antinukleære antistoffer (ANA)
- Godta å ikke bli gravid i løpet av rettssaken
- Ha en SELENA-SLEDAI-score på ≥6. (Deltakeren må aktivt vise alle symptomene som ble scoret på screeningen SELENA-SLEDAI på screeningsdagen.)
Ekskluderingskriterier:
- Har aktiv alvorlig Lupus nyresykdom
- Har aktivt sentralnervesystem eller perifer nevrologisk sykdom
- Har fått intravenøst immunglobulin (IVIg) innen 180 dager etter randomisering
- Har aktiv eller nylig infeksjon innen 30 dager etter screening
- Har hatt en alvorlig infeksjon innen 90 dager etter randomisering
- Har bevis eller test positivt for hepatitt B
- Har hepatitt C
- Er humant immunsviktvirus (HIV) positive
- Har tegn på aktiv eller latent tuberkulose (TB)
- Tilstedeværelse av betydelige laboratorieavvik ved screening
- Har hatt en malignitet de siste 5 årene, bortsett fra livmorhalskreft in-situ eller basalcelle eller plateepitelhudcelle som ble fullstendig resekert uten gjentakelse i løpet av de 3 årene før randomisering
- Har mottatt mer enn 40 mg prednison eller tilsvarende de siste 30 dagene
- Har endret dosen av malariamedisin i løpet av de siste 30 dagene
- Har endret dosen av immunsuppressivt legemiddel de siste 90 dagene
- Har tidligere fått rituximab
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: BEHANDLING
- Tildeling: TILFELDIG
- Intervensjonsmodell: PARALLELL
- Masking: FIDOBBELT
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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PLACEBO_COMPARATOR: Placebo
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Administrert via subkutan injeksjon i 52 uker.
En matchende startdose vil også bli administrert ved den første dosen.
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EKSPERIMENTELL: LY2127399 annenhver uke
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120 mg administrert via subkutan injeksjon i 52 uker.
240 mg startdose vil bli administrert som den første dosen av studiemedikamentet
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EKSPERIMENTELL: LY2127399 hver 4. uke
I løpet av behandlingsperioden vil deltakerne, for blindende formål, veksle injeksjoner av LY2127399 og injeksjoner med placebo hver 2. uke.
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Administrert via subkutan injeksjon i 52 uker.
120 mg administrert via subkutan injeksjon i 52 uker.
240 mg startdose vil bli administrert som den første dosen av studiemedikamentet
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Prosentandel av deltakere som oppnår en SLE-responderindeksrespons ved uke 52
Tidsramme: 52 uker
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Prosentandel av deltakere med ≥ 5 poeng reduksjon fra baseline i SELENA SLEDAI-score, og ingen forverring (økning på < 0,30 poeng fra baseline) i PGA, og ingen ny BILAG A-organdomene-score eller 2 nye BILAG B-organdomene-score sammenlignet med baseline . SELENA SLEDAI er beregnet fra 24 individuelle deskriptorer på tvers av 9 organsystemer; 0 indikerer inaktiv sykdom og maksimal teoretisk poengsum er 105; skårer > 20 er sjeldne. PGA er en visuell analog skala fra 0 til 3 (0=ingen, 1=mild, 2=moderat, 3=alvorlig). BILAG bruker et enkelt partitur for hvert av de 9 orgeldomenene; området er fra alvorlig (A) til ingen sykdom (E). Deltakere som ikke var i stand til å overholde tillatte krav til samtidig medisinering, ble ansett som ikke-responderere, det samme var deltakere som falt fra eller manglet data fra uke 52. |
52 uker
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Endring fra baseline til 52 uker i anti-dobbeltstrenget deoksyribonukleinsyre (anti-dsDNA) nivå
Tidsramme: Utgangspunkt, 52 uker
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Anti-dobbeltstrenget deoksyribonukleinsyre (anti-dsDNA) er en laboratorieanalyt som brukes til å diagnostisere SLE.
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Utgangspunkt, 52 uker
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Endring fra baseline til 52 ukers endepunkt i systemisk lupus erythematosus sykdomsaktivitetsindeks (SLEDAI2K) score
Tidsramme: Utgangspunkt, 52 uker
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SLE Disease Activity Index 2000 (SLEDAI-2K) poengsum er en vektet, kumulativ indeks for lupus sykdomsaktivitet.
SLEDAI-2K er beregnet fra 24 individuelle deskriptorer på tvers av 9 organsystemer; 0 indikerer inaktiv sykdom og den maksimale teoretiske poengsummen er 105.
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Utgangspunkt, 52 uker
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Tid til første alvorlige SLE-bluss (SFI)
Tidsramme: Baseline gjennom 52 uker
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SFI bruker SELENA-SLEDAI sykdomsaktivitetsindeksscore, sykdomsaktivitetsscenarier, behandlingsendringer og PGA for å definere milde/moderate og alvorlige oppblussinger. Indeksen tar hensyn til den absolutte endringen i totalskår, nye eller forverrede symptomer, og økning i kortikosteroidbruk eller sykehusinnleggelse på grunn av sykdomsaktiviteten. Tid til første alvorlige SLE-oppbluss (SFI) (i dager) beregnes som: (Startdato for første alvorlige SLE-oppbluss (SFI) - Dato for randomisering + 1). |
Baseline gjennom 52 uker
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Endring fra baseline til 52-ukers endepunkt i kort tretthetsinventar (BFI)-score
Tidsramme: Utgangspunkt, 52 uker
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En deltakerrapportert skala som måler alvorlighetsgraden av tretthet basert på den verste trettheten som er opplevd i løpet av de siste 24 timene.
Alvorlighetsskårene varierte fra 0 (ingen tretthet) til 10 (tretthet så alvorlig som du kan forestille deg).
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Utgangspunkt, 52 uker
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Tid til første New British Isles Lupus Assessment Group (BILAG A) eller 2 nye BILAG B SLE fakkel
Tidsramme: Baseline gjennom 52 uker
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Instrumentet British Isles Lupus Assessment Group (BILAG) vurderer global sykdomsaktivitet på tvers av 9 organsystemdomener. BILAG flare vurderes for hvert av de 9 organdomenene ved å bruke BILAG2004 indeks flare regler; A er en kraftig oppblussing og B er en moderat oppblussing. Tid til første BILAG A eller to BILAG B-bluss (i dager) beregnes som: (Startdato for første BILAG A eller to BILAG B-bluss - Dato for randomisering + 1). De to BILAG B-blussene må oppstå i forskjellige domener ved samme besøk. |
Baseline gjennom 52 uker
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Prosentandel av deltakere med en økning i kortikosteroiddose ved 52 uker
Tidsramme: 52 uker
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En økning i kortikosteroider ved et besøk ble definert som en endring fra baseline større enn 2,5 mg/dag i dose eller prednison eller tilsvarende ved bruk av gjennomsnittlig daglig dose kortikosteroider tatt siden forrige planlagte besøk.
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52 uker
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Endring fra baseline til 52 ukers endepunkt i SELENA-SLEDAI sykdomsaktivitetspoeng
Tidsramme: Utgangspunkt, 52 uker
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Sikkerhet for østrogener i Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) poengsum er en vektet, kumulativ indeks for lupus sykdomsaktivitet.
SELENA-SLEDAI er beregnet fra 24 individuelle deskriptorer på tvers av 9 organsystemer; 0 indikerer inaktiv sykdom og den maksimale teoretiske poengsummen er 105.
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Utgangspunkt, 52 uker
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Prosentandel av deltakere som er i stand til å redusere dosen av prednison eller tilsvarende uten økning i sykdomsaktivitet ved uke 52
Tidsramme: 52 uker
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En deltaker oppnår kortikosteroidsparende effekter (hvilende sykdom) hvis de har oppfylt følgende kriterier i løpet av uke 24 til og med 52; i stand til å redusere dosen av prednison eller tilsvarende 7,5 mg/dag eller mindre, har hvilende sykdom (BILAG C-score eller bedre i alle ni systemer), og ingen BILAG A- eller B-oppbluss i de foregående tre månedene, uten en økning i noen av antimalariamidler eller immundempende midler på eller før besøket.
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52 uker
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Endring fra baseline til 52 ukers endepunkt i Physician's Global Assessment (PGA)
Tidsramme: Utgangspunkt, 52 uker
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PGA er en klinikervurdert vurdering av et enkelt element av deltakerens nåværende nivå av sykdomsaktivitet målt på en kontinuerlig 100 millimeter (mm) visuell analytisk skala med benchmarks på 0, 1, 2 og 3 fra venstre til høyre tilsvarende nei, mild , moderat og alvorlig SLE sykdomsaktivitet.
Poeng er presentert fra 0 til 100.
Ingen forverring definert som økning på ≤ 0,30 poeng fra baseline.
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Utgangspunkt, 52 uker
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Endring fra baseline til 52 ukers endepunkt Lupus livskvalitet (LupusQOL) domenepoeng
Tidsramme: Utgangspunkt, 52 uker
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LupusQoL er et sykdomsspesifikt, 34-elements, selvrapporterende spørreskjema designet for å måle helserelatert livskvalitet (HRQoL) til deltakere med SLE innenfor 8 domener. Svarene er basert på en 5-punkts Likert-skala hvor 0 ( hele tiden) til 4 (aldri).
En LupusQoL-score for hvert domene rapporteres på en skala fra 0 til 100, med høyere verdier som indikerer bedre HRQoL.
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Utgangspunkt, 52 uker
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Prosentandel av deltakere uten forverring i Physician Global Assessment (PGA)-score ved 52 uker
Tidsramme: 52 uker
|
Physician's Global Assessment (PGA) er en klinikervurdert vurdering av deltakerens nåværende nivå av sykdomsaktivitet målt på en kontinuerlig 100 mm visuell analytisk skala med benchmarks på 0, 1, 2 og 3 fra venstre til høyre som tilsvarer no. , mild, moderat og alvorlig SLE sykdomsaktivitet.
Poeng er presentert fra 0 til 100. Ingen forverring definert som en økning på ≤ 0,30 poeng fra baseline.
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52 uker
|
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Antall deltakere uten ny BILAG A og ikke mer enn én ny BILAG B sykdomsaktivitetspoeng sammenlignet med baseline
Tidsramme: Baseline gjennom 52 uker
|
Instrumentet British Isles Lupus Assessment Group (BILAG) vurderer global sykdomsaktivitet på tvers av 9 organsystemdomener.
BILAG flare vurderes for hvert av de 9 organdomenene ved å bruke BILAG2004 indeks flare regler; A er en kraftig oppblussing og B er en moderat oppblussing.
|
Baseline gjennom 52 uker
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Prosentandel av deltakere som oppnår en respons målt ved modifisert SRI uten BILAG A eller ikke mer enn 1 BILAG B-organdomeneutbrudd ved 52 uker
Tidsramme: 52 uker
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Prosentandel av deltakere med ≥ 5 poeng reduksjon fra baseline i SELENA SLEDAI-score, og ingen forverring (økning på < 0,30 poeng fra baseline) i PGA, og ingen ny BILAG A eller ikke mer enn 1 ny BILAG B-organdomenebluss sammenlignet med baseline . (Primært utfall modifisert for å bruke BILAG-oppblussing i stedet for BILAG sykdomsscore) SELENA SLEDAI er beregnet fra 24 individuelle deskriptorer på tvers av 9 organsystemer; 0 indikerer inaktiv sykdom og den maksimale teoretiske poengsummen er 105. PGA er en visuell analog skala fra 0 til 3 (0=ingen, 1=mild, 2=moderat, 3=alvorlig). BILAG flare vurderes for hvert av de 9 organdomenene; A er en kraftig oppblussing og B er en moderat oppblussing. Deltakere som ikke var i stand til å overholde tillatte krav til samtidig medisinering, ble ansett som ikke-responderere, det samme var deltakere som falt fra eller manglet data fra uke 52. |
52 uker
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2011
Primær fullføring (FAKTISKE)
1. august 2014
Studiet fullført (FAKTISKE)
1. mars 2015
Datoer for studieregistrering
Først innsendt
17. september 2010
Først innsendt som oppfylte QC-kriteriene
17. september 2010
Først lagt ut (ANSLAG)
20. september 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (FAKTISKE)
17. juli 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juni 2018
Sist bekreftet
1. juni 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 13653
- H9B-MC-BCDT (ANNEN: Eli Lilly and Company)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .