En undersøgelse af LY2127399 hos deltagere med systemisk lupus erythematosus
18. juni 2018 opdateret af: Eli Lilly and Company
En fase 3, multicenter, randomiseret, dobbeltblind, placebokontrolleret undersøgelse for at evaluere effektiviteten og sikkerheden af subkutan LY2127399 hos patienter med systemisk lupus erythematosus (SLE)
Formålet med denne SLE-undersøgelse er at evaluere effektiviteten, sikkerheden og tolerabiliteten af to forskellige doser af LY2127399 administreret som supplement til standardbehandlingsterapi hos deltagere med aktiv SLE.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1124
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Malvern East, Australien, 3145
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New South Wales
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St Leonards, New South Wales, Australien, 2065
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Queensland
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Cairns, Queensland, Australien, 4870
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Maroochydore, Queensland, Australien, 4558
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Victoria
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Clayton, Victoria, Australien, 3168
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Heidelberg, Victoria, Australien, 3081
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Campinas, Brasilien, 13015-011
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Goiania, Brasilien, 74110-120
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Juiz De Fora, Brasilien, 36010-570
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Porto Alegre, Brasilien, 91350-200
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Salvador, Brasilien, 40050-410
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São Paulo, Brasilien, 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 Føderation, 454076
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Ekaterinburg, Den Russiske Føderation, 620012
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Kazan, Den Russiske Føderation, 420097
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Kemerovo, Den Russiske Føderation, 650099
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Moscow, Den Russiske Føderation, 125101
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Orenburg, Den Russiske Føderation, 460018
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Saint Petersburg, Den Russiske Føderation, 197089
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Tomsk, Den Russiske Føderation, 634063
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Yaroslavl, Den Russiske Føderation, 150023
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London, Det Forenede Kongerige, SE1 7EH
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Cambridgeshire
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Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0QQ
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Dorset
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Poole, Dorset, Det Forenede Kongerige, BH15 2JB
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Greater London
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London, Greater London, Det Forenede Kongerige, E11 1NR
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Kent
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Maidstone, Kent, Det Forenede Kongerige, ME16 9QQ
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Lancashire
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Wigan, Lancashire, Det Forenede Kongerige, WN6 0LW
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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, Forenede Stater, 36207
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Birmingham, Alabama, Forenede Stater, 35216
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Arizona
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Gilbert, Arizona, Forenede Stater, 85234
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Scottsdale, Arizona, Forenede Stater, 85258
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Tempe, Arizona, Forenede Stater, 85282
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Arkansas
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Malvern, Arkansas, Forenede Stater, 72104
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California
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Covina, California, Forenede Stater, 91723
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El Cajon, California, Forenede Stater, 92020
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Escondido, California, Forenede Stater, 92027
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La Mesa, California, Forenede Stater, 91941
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Lakewood, California, Forenede Stater, 90712
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Los Alamitos, California, Forenede Stater, 90720
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Los Angeles, California, Forenede Stater, 90095
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Pasadena, California, Forenede Stater, 91107
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Riverside, California, Forenede Stater, 92506
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San Diego, California, Forenede Stater, 92108
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San Gabriel, California, Forenede Stater, 91776
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Santa Barbara, California, Forenede Stater, 93108
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Van Nuys, California, Forenede Stater, 91405
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Westlake Village, California, Forenede Stater, 91361
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Whittier, California, Forenede Stater, 90606
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20060
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Florida
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Aventura, Florida, Forenede Stater, 33180
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DeBary, Florida, Forenede Stater, 32713
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Miami, Florida, Forenede Stater, 33175
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Naples, Florida, Forenede Stater, 34102
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New Port Richey, Florida, Forenede Stater, 34652
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Ormond Beach, Florida, Forenede Stater, 32174
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Pensacola, Florida, Forenede Stater, 32514
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Pinellas Park, Florida, Forenede Stater, 33781
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Plantation, Florida, Forenede Stater, 33324
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South Miami, Florida, Forenede Stater, 33143
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Tampa, Florida, Forenede Stater, 33603
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Vero Beach, Florida, Forenede Stater, 32960
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Georgia
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Atlanta, Georgia, Forenede Stater, 30303
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Duluth, Georgia, Forenede Stater, 30096
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Lithonia, Georgia, Forenede Stater, 30038
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Idaho
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Meridian, Idaho, Forenede Stater, 83642
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
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Rockford, Illinois, Forenede Stater, 61107
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46804
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Granger, Indiana, Forenede Stater, 46530
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Indianapolis, Indiana, Forenede Stater, 46202
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Louisiana
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Monroe, Louisiana, Forenede Stater, 71203
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Maine
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Portland, Maine, Forenede Stater, 04102
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Maryland
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Cumberland, Maryland, Forenede Stater, 21502
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Michigan
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Saint Clair Shores, Michigan, Forenede Stater, 48081
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39402
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Missouri
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Saint Louis, Missouri, Forenede Stater, 63117
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89128
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New Hampshire
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Nashua, New Hampshire, Forenede Stater, 03060
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New Jersey
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Freehold, New Jersey, Forenede Stater, 07728
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Voorhees, New Jersey, Forenede Stater, 08043
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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 Mexico
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Las Cruces, New Mexico, Forenede Stater, 88011
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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Albany, New York, Forenede 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, Forenede Stater, 11201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manhasset, New York, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede Stater, 44109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toledo, Ohio, Forenede 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, Forenede Stater, 73104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Duncansville, Pennsylvania, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede Stater, 37909
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Memphis, Tennessee, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede 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, Forenede Stater, 99204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Virginia
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Clarksburg, West Virginia, Forenede Stater, 26301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Orleans, Frankrig, 45000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Strasbourg, Frankrig, 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, Indien, 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, Indien, 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, Indien, 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, Indien, 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, Indien, 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, Indien, 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, Indien, 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, Letland, LV-1002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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, Rumænien, 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, Rumænien, 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, Rumænien, 400006
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Galati, Rumænien, 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, Rumænien, 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, Rumænien, 540136
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Belgrade, Serbien, 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, Serbien, 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, Serbien, 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, Serbien, 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, Spanien, 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, Spanien, 48013
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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La Coruña, Spanien, 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, Spanien, 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, Spanien, 28040
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Málaga, Spanien, 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, Spanien, 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, Spanien, 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, Spanien, 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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Cape Town, Sydafrika, 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, Sydafrika, 4001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Stellenbosch, Sydafrika, 7600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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, Tunesien, 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, Tunesien, 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, Tunesien, 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, Tunesien, 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, Tunesien, 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, Tunesien, 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
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, 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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (VOKSEN, OLDER_ADULT)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Klinisk diagnose af SLE som defineret af American College of Rheumatology (ACR) kriterier
- Har positive antinukleære antistoffer (ANA)
- Aftal ikke at blive gravid i løbet af forsøget
- Har en screening SELENA-SLEDAI score ≥6. (Deltageren skal aktivt udvise alle symptomer, der er scoret på screeningen SELENA-SLEDAI på screeningsdagen.)
Ekskluderingskriterier:
- Har aktiv alvorlig Lupus nyresygdom
- Har aktivt centralnervesystem eller perifer neurologisk sygdom
- Har modtaget intravenøst immunglobulin (IVIg) inden for 180 dage efter randomisering
- Har aktiv eller nylig infektion inden for 30 dage efter screening
- Har haft en alvorlig infektion inden for 90 dage efter randomisering
- Har bevis eller test positiv for hepatitis B
- Har hepatitis C
- Er human immundefektvirus (HIV) positive
- Har tegn på aktiv eller latent tuberkulose (TB)
- Tilstedeværelse af væsentlige laboratorieabnormiteter ved screening
- Har haft en malignitet inden for de seneste 5 år, bortset fra cervikal carcinom in-situ eller basalcelle eller pladeepitelhudcelle, som blev fuldstændigt resekeret uden gentagelse i de 3 år før randomisering
- Har modtaget mere end 40 mg prednison eller tilsvarende inden for de seneste 30 dage
- Har ændret din dosis af antimalariamiddel inden for de seneste 30 dage
- Har ændret din dosis af immunsuppressiv medicin inden for de seneste 90 dage
- Har tidligere fået rituximab
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: BEHANDLING
- Tildeling: TILFÆLDIGT
- Interventionel model: PARALLEL
- Maskning: FIDOBELT
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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PLACEBO_COMPARATOR: Placebo
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Indgivet via subkutan injektion i 52 uger.
En matchende startdosis vil også blive administreret ved den første dosis.
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EKSPERIMENTEL: LY2127399 hver 2. uge
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120 mg administreret via subkutan injektion i 52 uger.
240 mg startdosis vil blive administreret som den første dosis af undersøgelseslægemidlet
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EKSPERIMENTEL: LY2127399 hver 4. uge
I løbet af behandlingsperioden vil deltagerne af blindende formål skiftevis injektioner af LY2127399 og injektioner af placebo hver anden uge.
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Indgivet via subkutan injektion i 52 uger.
120 mg administreret via subkutan injektion i 52 uger.
240 mg startdosis vil blive administreret som den første dosis af undersøgelseslægemidlet
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Procentdel af deltagere, der opnår et SLE-responderindekssvar i uge 52
Tidsramme: 52 uger
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Procentdel af deltagere med en ≥ 5 point reduktion fra baseline i SELENA SLEDAI-score og ingen forværring (stigning på < 0,30 point fra baseline) i PGA og ingen ny BILAG A-organdomænescore eller 2 nye BILAG B-organdomænescores sammenlignet med baseline . SELENA SLEDAI er beregnet ud fra 24 individuelle deskriptorer på tværs af 9 organsystemer; 0 indikerer inaktiv sygdom, og den maksimale teoretiske score er 105; score > 20 er sjældne. PGA er en visuel analog skala fra 0 til 3 (0=ingen, 1=mild, 2=moderat, 3=alvorlig). BILAG bruger et enkelt partitur for hvert af de 9 organdomæner; intervallet er fra svær (A) til ingen sygdom (E). Deltagere, der ikke var i stand til at overholde tilladte samtidige medicinkrav, blev betragtet som ikke-responderende, ligesom deltagere, der droppede ud eller manglede data fra uge 52. |
52 uger
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ændring fra baseline til 52 uger i anti-dobbeltstrenget deoxyribonukleinsyre (anti-dsDNA) niveau
Tidsramme: Baseline, 52 uger
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Anti-dobbeltstrenget deoxyribonukleinsyre (anti-dsDNA) er en laboratorieanalyt, der bruges til at hjælpe med diagnosticering af SLE.
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Baseline, 52 uger
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Ændring fra baseline til 52 ugers slutpunkt i systemisk lupus erythematosus sygdom aktivitetsindeks (SLEDAI2K) score
Tidsramme: Baseline, 52 uger
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SLE Disease Activity Index 2000 (SLEDAI-2K) score er et vægtet, kumulativt indeks for lupus sygdomsaktivitet.
SLEDAI-2K er beregnet ud fra 24 individuelle deskriptorer på tværs af 9 organsystemer; 0 indikerer inaktiv sygdom, og den maksimale teoretiske score er 105.
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Baseline, 52 uger
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Tid til første alvorlige SLE-udbrud (SFI)
Tidsramme: Baseline gennem 52 uger
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SFI bruger SELENA-SLEDAI sygdomsaktivitetsindeksscore, sygdomsaktivitetsscenarier, behandlingsændringer og PGA til at definere milde/moderate og svære opblussen. Indekset tager højde for den absolutte ændring i totalscore, nye eller forværrede symptomer og stigninger i kortikosteroidbrug eller indlæggelse på grund af sygdomsaktiviteten. Tid til første alvorlige SLE-opblussen (SFI) (i dage) beregnes som: (Startdato for første alvorlige SLE-opblussen (SFI) - Dato for randomisering + 1). |
Baseline gennem 52 uger
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Ændring fra baseline til 52 ugers slutpunkt i kort træthedsoversigt (BFI)-resultater
Tidsramme: Baseline, 52 uger
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En deltagerrapporteret skala, der måler sværhedsgraden af træthed baseret på den værste træthed oplevet i løbet af de seneste 24 timer.
Sværhedsgraden varierede fra 0 (ingen træthed) til 10 (træthed så alvorlig, som du kan forestille dig).
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Baseline, 52 uger
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Tid til første New British Isles Lupus Assessment Group (BILAG A) eller 2 nye BILAG B SLE-blus
Tidsramme: Baseline gennem 52 uger
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Instrumentet British Isles Lupus Assessment Group (BILAG) vurderer global sygdomsaktivitet på tværs af 9 organsystemdomæner. BILAG flare vurderes for hvert af de 9 organdomæner ved hjælp af BILAG2004 indeks flare regler; A er en alvorlig opblussen og B er en moderat opblussen. Tid til første BILAG A eller to BILAG B-udbrud (i dage) beregnes som: (Startdato for første BILAG A eller to BILAG B-udbrud - Dato for randomisering + 1). De to BILAG B-blus skal forekomme i forskellige domæner ved samme besøg. |
Baseline gennem 52 uger
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Procentdel af deltagere med en stigning i kortikosteroiddosis efter 52 uger
Tidsramme: 52 uger
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En stigning i kortikosteroider ved et besøg blev defineret som en ændring fra baseline større end 2,5 mg/dag i dosis eller prednison eller tilsvarende ved brug af den gennemsnitlige daglige dosis af kortikosteroider taget siden det tidligere planlagte besøg.
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52 uger
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Ændring fra baseline til 52 ugers slutpunkt i SELENA-SLEDAI sygdomsaktivitetsscore
Tidsramme: Baseline, 52 uger
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Sikkerhed af østrogener i Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score er et vægtet, kumulativt indeks for lupus sygdomsaktivitet.
SELENA-SLEDAI er beregnet ud fra 24 individuelle deskriptorer på tværs af 9 organsystemer; 0 indikerer inaktiv sygdom, og den maksimale teoretiske score er 105.
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Baseline, 52 uger
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Procentdel af deltagere, der er i stand til at reducere dosis af prednison eller tilsvarende uden stigning i sygdomsaktivitet i uge 52
Tidsramme: 52 uger
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En deltager opnår kortikosteroidbesparende virkninger (hvilende sygdom), hvis de har opfyldt følgende kriterier i uge 24 til 52; i stand til at nedsætte deres dosis af prednison eller svarende til 7,5 mg/dag eller mindre, have hvilende sygdom (BILAG C-score eller bedre i alle ni systemer) og ingen BILAG A- eller B-opblussen i de foregående tre måneder uden en stigning i enten antimalariamidler eller immunsuppressiva på eller før besøget.
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52 uger
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Ændring fra baseline til 52 ugers slutpunkt i lægens globale vurdering (PGA)
Tidsramme: Baseline, 52 uger
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PGA er en klinikbedømt vurdering af et enkelt element af deltagerens aktuelle niveau af sygdomsaktivitet målt på en kontinuerlig 100 millimeter (mm) visuel analytisk skala med benchmarks på 0, 1, 2 og 3 fra venstre mod højre svarende til nej, mild , moderat og svær SLE-sygdomsaktivitet.
Score præsenteres fra 0 til 100.
Ingen forværring defineret som en stigning på ≤ 0,30 point fra baseline.
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Baseline, 52 uger
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Ændring fra baseline til 52 ugers slutpunkt Lupus livskvalitet (LupusQOL) domæneresultater
Tidsramme: Baseline, 52 uger
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LupusQoL er et sygdomsspecifikt, 34-punkts, selvrapporterende spørgeskema designet til at måle den sundhedsrelaterede livskvalitet (HRQoL) for deltagere med SLE inden for 8 domæner. Svarene er baseret på en 5-punkts Likert-skala, hvor 0 ( hele tiden) til 4 (aldrig).
En LupusQoL-score for hvert domæne rapporteres på en skala fra 0 til 100, hvor højere værdier indikerer bedre HRQoL.
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Baseline, 52 uger
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Procentdel af deltagere uden forværring i Physician Global Assessment (PGA)-score ved 52 uger
Tidsramme: 52 uger
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Physician's Global Assessment (PGA) er en kliniker vurderet med et enkelt element af deltagerens aktuelle niveau af sygdomsaktivitet målt på en kontinuerlig 100 mm visuel analytisk skala med benchmarks på 0, 1, 2 og 3 fra venstre mod højre svarende til nej , mild, moderat og svær SLE-sygdomsaktivitet.
Score er præsenteret fra 0 til 100. Ingen forværring defineret som en stigning på ≤ 0,30 point fra baseline.
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52 uger
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Antal deltagere uden ny BILAG A og ikke mere end én ny BILAG B-sygdomsaktivitetsscore sammenlignet med baseline
Tidsramme: Baseline gennem 52 uger
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Instrumentet British Isles Lupus Assessment Group (BILAG) vurderer global sygdomsaktivitet på tværs af 9 organsystemdomæner.
BILAG flare vurderes for hvert af de 9 organdomæner ved hjælp af BILAG2004 indeks flare regler; A er en alvorlig opblussen og B er en moderat opblussen.
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Baseline gennem 52 uger
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Procentdel af deltagere, der opnår en respons målt ved modificeret SRI uden BILAG A eller ikke mere end 1 BILAG B-organdomæneudbrud efter 52 uger
Tidsramme: 52 uger
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Procentdel af deltagere med en ≥ 5 point reduktion fra baseline i SELENA SLEDAI score og ingen forværring (stigning på < 0,30 point fra baseline) i PGA, og ingen ny BILAG A eller ikke mere end 1 ny BILAG B organdomæne flare sammenlignet med baseline . (Primært resultat modificeret til at bruge BILAG flare i stedet for BILAG sygdomsscore) SELENA SLEDAI er beregnet ud fra 24 individuelle deskriptorer på tværs af 9 organsystemer; 0 indikerer inaktiv sygdom, og den maksimale teoretiske score er 105. PGA er en visuel analog skala fra 0 til 3 (0=ingen, 1=mild, 2=moderat, 3=alvorlig). BILAG flare vurderes for hvert af de 9 organdomæner; A er en alvorlig opblussen og B er en moderat opblussen. Deltagere, der ikke var i stand til at overholde tilladte samtidige medicinkrav, blev betragtet som ikke-responderende, ligesom deltagere, der droppede ud eller manglede data fra uge 52. |
52 uger
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2011
Primær færdiggørelse (FAKTISKE)
1. august 2014
Studieafslutning (FAKTISKE)
1. marts 2015
Datoer for studieregistrering
Først indsendt
17. september 2010
Først indsendt, der opfyldte QC-kriterier
17. september 2010
Først opslået (SKØN)
20. september 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (FAKTISKE)
17. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13653
- H9B-MC-BCDT (ANDET: Eli Lilly and Company)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .