Tutkimus LY2127399:stä potilailla, joilla on systeeminen lupus erythematosus
maanantai 18. kesäkuuta 2018 päivittänyt: Eli Lilly and Company
Vaihe 3, monikeskus, satunnaistettu, kaksoissokkoutettu, lumekontrolloitu tutkimus ihonalaisen LY2127399:n tehon ja turvallisuuden arvioimiseksi potilailla, joilla on systeeminen lupus erythematosus (SLE)
Tämän SLE-tutkimuksen tarkoituksena on arvioida kahden eri LY2127399-annoksen tehoa, turvallisuutta ja siedettävyyttä, kun niitä annettiin normaalin hoitohoidon lisäksi potilailla, joilla on aktiivinen SLE.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
1124
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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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, Brasilia, 13015-011
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Goiania, Brasilia, 74110-120
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Juiz De Fora, Brasilia, 36010-570
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Porto Alegre, Brasilia, 91350-200
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Salvador, Brasilia, 40050-410
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São Paulo, Brasilia, 04039-901
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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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Barcelona, Espanja, 08035
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Bilbao, Espanja, 48013
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La Coruña, Espanja, 15006
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Las Palmas De Gran Canaria, Espanja, 35010
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Madrid, Espanja, 28040
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Málaga, Espanja, 29010
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Santiago De Compostela, Espanja, 15706
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Sevilla, Espanja, 41071
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Vigo, Espanja, 36200
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Cape Town, Etelä-Afrikka, 7925
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Durban, Etelä-Afrikka, 4001
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Stellenbosch, Etelä-Afrikka, 7600
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Bangalore, Intia, 560043
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Gujarat, Intia, 380015
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Haryana, Intia, 122001
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Hyderabaad, Intia, 500082
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Kormangala, Intia, 560034
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Pune, Intia, 411007
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Trivandrum, Intia, 695011
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Haifa, Israel, 34362
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Kfar Saba, Israel, 44281
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Petah Tikva, Israel, 49100
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Tel Hashomer, Israel, 52651
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Zerifin, Israel, 70300
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Ontario
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Hamilton, Ontario, Kanada, L8N 3Z5
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Quebec
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Trois-Rivieres, Quebec, Kanada, G8Z 1Y2
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Riga, Latvia, LV-1002
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Kota Kinabalu, Malesia, 88586
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Kuala Lumpur, Malesia, 59100
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Guadalajara, Meksiko, 44650
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Merida, Meksiko, 97130
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Mexico City, Meksiko, 06090
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San Luis, Meksiko, 78240
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San Luis Potosi, Meksiko, 78200
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Tijuana, Meksiko, 22010
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Orleans, Ranska, 45000
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Strasbourg, Ranska, 67091
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Brasov, Romania, 500283
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Bucharest, Romania, 020475
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Cluj-Napoca, Romania, 400006
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Galati, Romania, 800587
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Iasi, Romania, 700656
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Targu Mures, Romania, 540136
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Belgrade, Serbia, 11000
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Kragujevac, Serbia, 34000
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Niska Banja, Serbia, 18205
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Novi Sad, Serbia, 21000
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Changhua, Taiwan, 500
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Hualien, Taiwan, 970
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Kaohsiung, Taiwan, 833
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Taichung, Taiwan, 40705
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Taichung City, Taiwan, 40201
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Taipei, Taiwan, 10630
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La Marsa, Tunisia, 2070
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Monastir, Tunisia, 5000
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Sfax, Tunisia, 3029
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Sousse, Tunisia, 4000
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Tunis, Tunisia, 1008
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Tunis Monfleury, Tunisia, 1008
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Budapest, Unkari, 1027
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Debrecen, Unkari, 4032
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Gyor, Unkari, 9023
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Gyula, Unkari, 5700
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Szeged, Unkari, 6720
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Hamilton, Uusi Seelanti, 3204
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Otahuhu, Uusi Seelanti, 1640
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Takapuna, Uusi Seelanti, 622
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Chelyabinsk, Venäjän federaatio, 454076
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Ekaterinburg, Venäjän federaatio, 620012
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Kazan, Venäjän federaatio, 420097
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Kemerovo, Venäjän federaatio, 650099
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Moscow, Venäjän federaatio, 125101
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Orenburg, Venäjän federaatio, 460018
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Saint Petersburg, Venäjän federaatio, 197089
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Tomsk, Venäjän federaatio, 634063
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yaroslavl, Venäjän federaatio, 150023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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London, Yhdistynyt kuningaskunta, 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
-
Cambridge, Cambridgeshire, Yhdistynyt kuningaskunta, 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, Yhdistynyt kuningaskunta, 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
-
London, Greater London, Yhdistynyt kuningaskunta, 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
-
Maidstone, Kent, Yhdistynyt kuningaskunta, 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
-
Wigan, Lancashire, Yhdistynyt kuningaskunta, 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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Alabama
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Anniston, Alabama, Yhdysvallat, 36207
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Birmingham, Alabama, Yhdysvallat, 35216
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arizona
-
Gilbert, Arizona, Yhdysvallat, 85234
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Scottsdale, Arizona, Yhdysvallat, 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, Yhdysvallat, 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
-
Malvern, Arkansas, Yhdysvallat, 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
-
Covina, California, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 91941
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lakewood, California, Yhdysvallat, 90712
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Los Alamitos, California, Yhdysvallat, 90720
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Los Angeles, California, Yhdysvallat, 90095
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pasadena, California, Yhdysvallat, 91107
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Riverside, California, Yhdysvallat, 92506
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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 Diego, California, Yhdysvallat, 92108
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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 Gabriel, California, Yhdysvallat, 91776
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Santa Barbara, California, Yhdysvallat, 93108
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Van Nuys, California, Yhdysvallat, 91405
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Westlake Village, California, Yhdysvallat, 91361
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Whittier, California, Yhdysvallat, 90606
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Colorado
-
Aurora, Colorado, Yhdysvallat, 80045
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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District of Columbia
-
Washington, District of Columbia, Yhdysvallat, 20060
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
-
Aventura, Florida, Yhdysvallat, 33180
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
DeBary, Florida, Yhdysvallat, 32713
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Miami, Florida, Yhdysvallat, 33175
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Naples, Florida, Yhdysvallat, 34102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
New Port Richey, Florida, Yhdysvallat, 34652
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Ormond Beach, Florida, Yhdysvallat, 32174
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Pensacola, Florida, Yhdysvallat, 32514
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Pinellas Park, Florida, Yhdysvallat, 33781
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Plantation, Florida, Yhdysvallat, 33324
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
South Miami, Florida, Yhdysvallat, 33143
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Tampa, Florida, Yhdysvallat, 33603
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Vero Beach, Florida, Yhdysvallat, 32960
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Georgia
-
Atlanta, Georgia, Yhdysvallat, 30303
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Duluth, Georgia, Yhdysvallat, 30096
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Lithonia, Georgia, Yhdysvallat, 30038
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Idaho
-
Meridian, Idaho, Yhdysvallat, 83642
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Illinois
-
Chicago, Illinois, Yhdysvallat, 60612
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Rockford, Illinois, Yhdysvallat, 61107
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Indiana
-
Fort Wayne, Indiana, Yhdysvallat, 46804
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Granger, Indiana, Yhdysvallat, 46530
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Indianapolis, Indiana, Yhdysvallat, 46202
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Louisiana
-
Monroe, Louisiana, Yhdysvallat, 71203
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Maine
-
Portland, Maine, Yhdysvallat, 04102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Maryland
-
Cumberland, Maryland, Yhdysvallat, 21502
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Michigan
-
Saint Clair Shores, Michigan, Yhdysvallat, 48081
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Minnesota
-
Duluth, Minnesota, Yhdysvallat, 55805
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Mississippi
-
Hattiesburg, Mississippi, Yhdysvallat, 39402
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Missouri
-
Saint Louis, Missouri, Yhdysvallat, 63117
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Nevada
-
Las Vegas, Nevada, Yhdysvallat, 89128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
New Hampshire
-
Nashua, New Hampshire, Yhdysvallat, 03060
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
New Jersey
-
Freehold, New Jersey, Yhdysvallat, 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.
-
Voorhees, New Jersey, Yhdysvallat, 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.
-
-
New Mexico
-
Las Cruces, New Mexico, Yhdysvallat, 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.
-
-
New York
-
Albany, New York, Yhdysvallat, 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.
-
Brooklyn, New York, Yhdysvallat, 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.
-
Manhasset, New York, Yhdysvallat, 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.
-
New York, New York, Yhdysvallat, 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.
-
New York, New York, Yhdysvallat, 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.
-
Plainview, New York, Yhdysvallat, 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.
-
Roslyn, New York, Yhdysvallat, 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.
-
-
North Carolina
-
Chapel Hill, North Carolina, Yhdysvallat, 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.
-
Charlotte, North Carolina, Yhdysvallat, 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.
-
Raleigh, North Carolina, Yhdysvallat, 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.
-
Rocky Mount, North Carolina, Yhdysvallat, 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.
-
-
Ohio
-
Cincinnati, Ohio, Yhdysvallat, 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.
-
Cleveland, Ohio, Yhdysvallat, 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.
-
Toledo, Ohio, Yhdysvallat, 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.
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Yhdysvallat, 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.
-
-
Pennsylvania
-
Duncansville, Pennsylvania, Yhdysvallat, 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.
-
Wyomissing, Pennsylvania, Yhdysvallat, 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.
-
-
South Carolina
-
Charleston, South Carolina, Yhdysvallat, 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.
-
-
Tennessee
-
Cookeville, Tennessee, Yhdysvallat, 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.
-
Knoxville, Tennessee, Yhdysvallat, 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.
-
Memphis, Tennessee, Yhdysvallat, 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.
-
Nashville, Tennessee, Yhdysvallat, 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.
-
-
Texas
-
Amarillo, Texas, Yhdysvallat, 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.
-
Austin, Texas, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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, Yhdysvallat, 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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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (AIKUINEN, OLDER_ADULT)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Sisällyttämiskriteerit:
- SLE:n kliininen diagnoosi American College of Rheumatologyn (ACR) kriteerien mukaisesti
- Sinulla on positiivisia antinukleaarisia vasta-aineita (ANA)
- Sovi, ettet tule raskaaksi koko kokeen ajan
- SELENA-SLEDAI-seulonnan pistemäärä on ≥6. (Osallistujalla tulee olla aktiivisesti kaikki SELENA-SLEDAI-seulonnassa pisteytetyt oireet seulontapäivänä.)
Poissulkemiskriteerit:
- Sinulla on aktiivinen vakava munuaissairaus Lupus
- Sinulla on aktiivinen keskushermosto tai perifeerinen neurologinen sairaus
- Olet saanut suonensisäistä immunoglobuliinia (IVIg) 180 päivän kuluessa satunnaistamisesta
- Sinulla on aktiivinen tai äskettäinen infektio 30 päivän sisällä seulonnasta
- Sinulla on ollut vakava infektio 90 päivän sisällä satunnaistamisesta
- Sinulla on todisteita tai testi positiivinen B-hepatiitti
- Onko hepatiitti C
- Ovatko ihmisen immuunikatovirus (HIV) positiivisia
- sinulla on näyttöä aktiivisesta tai piilevasta tuberkuloosista (TB)
- Merkittäviä laboratoriopoikkeavuuksia seulonnassa
- sinulla on ollut pahanlaatuinen kasvain viimeisten 5 vuoden aikana, paitsi kohdunkaulan in situ- tai tyvisolusyöpä tai levyepiteelin ihosolu, jotka on leikattu kokonaan ilman uusiutumista 3 vuoden aikana ennen satunnaistamista
- olet saanut yli 40 mg prednisonia tai vastaavaa viimeisten 30 päivän aikana
- Olet muuttanut malarialääkkeen annostasi viimeisen 30 päivän aikana
- Olet muuttanut immunosuppressiivisen lääkkeen annostasi viimeisten 90 päivän aikana
- olet aiemmin saanut rituksimabia
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: HOITO
- Jako: SATUNNAISTUNA
- Inventiomalli: RINNAKKAISET
- Naamiointi: NELINKERTAISTAA
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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PLACEBO_COMPARATOR: Plasebo
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Annettiin ihonalaisesti 52 viikon ajan.
Ensimmäisellä annoksella annetaan myös vastaava kyllästysannos.
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KOKEELLISTA: LY2127399 2 viikon välein
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120 mg ihonalaisena injektiona 52 viikon ajan.
240 mg:n kyllästysannos annetaan ensimmäisenä tutkimuslääkkeen annoksena
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KOKEELLISTA: LY2127399 4 viikon välein
Hoitojakson aikana osallistujat antavat vuorotellen LY2127399-injektioita ja lumelääkettä 2 viikon välein sokeuttamistarkoituksessa.
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Annettiin ihonalaisesti 52 viikon ajan.
120 mg ihonalaisena injektiona 52 viikon ajan.
240 mg:n kyllästysannos annetaan ensimmäisenä tutkimuslääkkeen annoksena
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Niiden osallistujien prosenttiosuus, jotka saavuttivat SLE-vasteindeksin vastauksen viikolla 52
Aikaikkuna: 52 viikkoa
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Niiden osallistujien prosenttiosuus, joiden SELENA SLEDAI -pistemäärä on laskenut ≥ 5 pistettä lähtötasosta, eikä PGA:ssa heikentynyt (lisäys < 0,30 pistettä lähtötasosta), eikä uusia BILAG A -elinaluepisteitä tai kahta uutta BILAG B -elinalueen pistettä verrattuna lähtötasoon . SELENA SLEDAI lasketaan 24 yksittäisestä kuvauksesta 9 elinjärjestelmässä; 0 tarkoittaa inaktiivista sairautta ja suurin teoreettinen pistemäärä on 105; pisteet > 20 ovat harvinaisia. PGA on visuaalinen analoginen asteikko 0-3 (0 = ei mitään, 1 = lievä, 2 = kohtalainen, 3 = vaikea). BILAG käyttää yhtä pistemäärää kullekin 9 elinalueelle; vaihteluväli on vakavasta (A) ei sairauteen (E). Osallistujat, jotka eivät kyenneet noudattamaan sallittuja samanaikaisten lääkkeiden vaatimuksia, katsottiin ei-vastettaviksi, samoin kuin osallistujat, jotka keskeyttivät tai puuttuivat viikon 52 tiedot. |
52 viikkoa
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Muutos lähtötilanteesta 52 viikkoon anti-kaksoisjuosteisen deoksiribonukleiinihapon (anti-dsDNA) tasolla
Aikaikkuna: Lähtötilanne, 52 viikkoa
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Anti-kaksijuosteinen deoksiribonukleiinihappo (anti-dsDNA) on laboratorioanalyytti, jota käytetään auttamaan SLE:n diagnosoinnissa.
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Lähtötilanne, 52 viikkoa
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Muutos lähtötilanteesta 52 viikon päätepisteeseen systeemisen lupus erythematosus -taudin aktiivisuusindeksissä (SLEDAI2K)
Aikaikkuna: Lähtötilanne, 52 viikkoa
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SLE-taudin aktiivisuusindeksin 2000 (SLEDAI-2K) pistemäärä on lupustaudin aktiivisuuden painotettu kumulatiivinen indeksi.
SLEDAI-2K lasketaan 24 yksittäisestä kuvauksesta 9 elinjärjestelmässä; 0 tarkoittaa inaktiivista sairautta ja teoreettinen enimmäispistemäärä on 105.
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Lähtötilanne, 52 viikkoa
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Aika ensimmäiseen vakavaan SLE-oireyhtymään (SFI)
Aikaikkuna: Lähtötilanne 52 viikon ajan
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SFI käyttää SELENA-SLEDAI-taudin aktiivisuusindeksiä, taudin aktiivisuusskenaarioita, hoitomuutoksia ja PGA:ta määrittääkseen lieviä/kohtalaisia ja vakavia pahenemisvaiheita. Indeksi ottaa huomioon kokonaispisteiden absoluuttisen muutoksen, uudet tai pahenevat oireet sekä sairauden aktiivisuudesta johtuvan kortikosteroidien käytön tai sairaalahoidon lisääntymisen. Aika ensimmäiseen vakavaan SLE:n pahenemiseen (SFI) (päivinä) lasketaan seuraavasti: (Ensimmäisen vakavan SLE-leimauksen (SFI) alkamispäivä - satunnaistamisen päivämäärä + 1). |
Lähtötilanne 52 viikon ajan
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Muutos perustilanteesta 52 viikon päätepisteeseen lyhyen väsymyskartoituksen (BFI) pisteissä
Aikaikkuna: Lähtötilanne, 52 viikkoa
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Osallistujien raportoima asteikko, joka mittaa väsymyksen vakavuutta viimeisen 24 tunnin aikana koetun pahimman väsymyksen perusteella.
Vakavuuspisteet vaihtelivat 0:sta (ei väsymystä) 10:een (niin vakava väsymys kuin voit kuvitella).
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Lähtötilanne, 52 viikkoa
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Aika ensimmäiseen New British Isles Lupus Assessment Groupiin (BILAG A) tai 2 uuteen BILAG B SLE-soittimeen
Aikaikkuna: Lähtötilanne 52 viikon ajan
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British Isles Lupus Assessment Group (BILAG) -instrumentti arvioi maailmanlaajuisen sairauden aktiivisuuden 9 elinjärjestelmän alueella. BILAG-leimaus arvioidaan kullekin yhdeksästä elinalueesta käyttämällä BILAG2004-indeksin flare-sääntöjä; A on voimakas leimahdus ja B on kohtalainen. Aika ensimmäiseen BILAG A:seen tai kahteen BILAG B-soihdutukseen (päivinä) lasketaan seuraavasti: (Ensimmäisen BILAG A:n tai kahden BILAG B:n alkamispäivämäärä - satunnaistamisen päivämäärä + 1). Kahden BILAG B -soihdun on tapahduttava eri aloilla samalla käynnillä. |
Lähtötilanne 52 viikon ajan
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Niiden osallistujien prosenttiosuus, joiden kortikosteroidiannos on kasvanut 52 viikon kohdalla
Aikaikkuna: 52 viikkoa
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Kortikosteroidien nousu käynnin aikana määriteltiin muutokseksi lähtötasosta yli 2,5 mg/vrk annoksessa tai prednisonissa tai vastaavassa käyttämällä edellisen suunnitellusta käynnistä otetun kortikosteroidien keskimääräistä päivittäistä annosta.
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52 viikkoa
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Muutos lähtötilanteesta 52 viikon päätepisteeseen SELENA-SLEDAI-taudin aktiivisuuspisteissä
Aikaikkuna: Lähtötilanne, 52 viikkoa
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Estrogeenien turvallisuus lupus erythematosus -tutkimuksessa National Assessment - SLE-taudin aktiivisuusindeksi (SELENA-SLEDAI) on painotettu, kumulatiivinen indeksi lupus-taudin aktiivisuudesta.
SELENA-SLEDAI lasketaan 24 yksittäisestä kuvauksesta 9 elinjärjestelmässä; 0 tarkoittaa inaktiivista sairautta ja teoreettinen enimmäispistemäärä on 105.
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Lähtötilanne, 52 viikkoa
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Niiden osallistujien prosenttiosuus, jotka pystyivät vähentämään prednisonin tai vastaavan annosta ilman sairauden aktiivisuuden lisääntymistä viikolla 52
Aikaikkuna: 52 viikkoa
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Osallistuja saavuttaa kortikosteroideja säästävät vaikutukset (lepotilasairaus), jos hän on täyttänyt seuraavat kriteerit viikkojen 24–52 aikana; jotka pystyvät alentamaan prednisonin tai vastaavan annosta 7,5 mg:aan/vrk tai pienemmäksi, heillä on lepotilassa oleva sairaus (BILAG C -pistemäärä tai parempi kaikissa yhdeksässä järjestelmässä) eikä BILAG A- tai BILAG A- tai B-leimahduksia edeltäneiden kolmen kuukauden aikana ilman, että kumpikaan malarialääkkeitä tai immunosuppressantteja käynnin aikana tai ennen sitä.
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52 viikkoa
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Muutos lähtötilanteesta 52 viikon päätepisteeseen lääkärin maailmanlaajuisessa arvioinnissa (PGA)
Aikaikkuna: Lähtötilanne, 52 viikkoa
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PGA on kliinikon yhden kohteen arvioima arvio osallistujan tämänhetkisestä taudin aktiivisuustasosta mitattuna jatkuvalla 100 millimetrin (mm) visuaalisella analyyttisellä asteikolla, jonka vertailuarvot 0, 1, 2 ja 3 vasemmalta oikealle vastaavat ei, lievä. , keskivaikea ja vaikea SLE-taudin aktiivisuus.
Pisteet esitetään 0-100.
Ei huononemista, mikä määritellään nousuksi ≤ 0,30 pistettä lähtötasosta.
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Lähtötilanne, 52 viikkoa
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Muutos perustasosta 52 viikon päätepisteen Lupus Life Quality of Life (LupusQOL) -verkkotunnuksen pisteet
Aikaikkuna: Lähtötilanne, 52 viikkoa
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LupusQoL on sairauskohtainen, 34 kohtainen, itseraportoiva kyselylomake, joka on suunniteltu mittaamaan SLE-potilaiden terveyteen liittyvää elämänlaatua (HRQoL) kahdeksalla alueella. Vastaukset perustuvat 5-pisteiseen Likert-asteikkoon, jossa 0 ( koko ajan) 4:ään (ei koskaan).
Kunkin alueen LupusQoL-pisteet raportoidaan asteikolla 0–100, ja suuremmat arvot osoittavat parempaa HRQoL:ää.
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Lähtötilanne, 52 viikkoa
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Niiden osallistujien prosenttiosuus, joiden lääkärin maailmanlaajuisen arvioinnin (PGA) tulos ei huonontunut 52 viikon kohdalla
Aikaikkuna: 52 viikkoa
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Physician's Global Assessment (PGA) on kliinikon yhden kohteen arvioima arvio osallistujan nykyisestä sairauden aktiivisuuden tasosta mitattuna jatkuvalla 100 mm:n visuaalisella analyyttisellä asteikolla, jossa vertailuarvot ovat 0, 1, 2 ja 3 vasemmalta oikealle, mikä vastaa ei-arvoa. , lievä, keskivaikea ja vaikea SLE-taudin aktiivisuus.
Pisteet esitetään välillä 0 - 100. Ei huononemista, jotka määritellään nousuksi ≤ 0,30 pistettä lähtötasosta.
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52 viikkoa
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Niiden osallistujien määrä, joilla ei ole uutta BILAG A:ta eikä enempää kuin yksi uusi BILAG B -taudin aktiivisuuspisteet verrattuna lähtötasoon
Aikaikkuna: Lähtötilanne 52 viikon ajan
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British Isles Lupus Assessment Group (BILAG) -instrumentti arvioi maailmanlaajuisen sairauden aktiivisuuden 9 elinjärjestelmän alueella.
BILAG-leimaus arvioidaan kullekin yhdeksästä elinalueesta käyttämällä BILAG2004-indeksin flare-sääntöjä; A on voimakas leimahdus ja B on kohtalainen.
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Lähtötilanne 52 viikon ajan
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Niiden osallistujien prosenttiosuus, jotka saavuttivat vastauksen modifioidulla SRI:llä mitattuna ilman BILAG A:ta tai enintään yhtä BILAG B -elinverkkotunnuksen leimahdusta 52 viikon kohdalla
Aikaikkuna: 52 viikkoa
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Niiden osallistujien prosenttiosuus, joiden SELENA SLEDAI -pistemäärä on laskenut ≥ 5 pistettä lähtötasosta, eikä PGA ole huonontunut (lisäys < 0,30 pistettä lähtötasosta) eikä uutta BILAG A:ta tai korkeintaan 1 uusi BILAG B -elinverkkotunnus verrattuna lähtötasoon . (Ensisijainen tulos muutettu käyttämään BILAG-sairautta BILAG-sairauspisteen sijaan) SELENA SLEDAI lasketaan 24 yksittäisestä kuvauksesta 9 elinjärjestelmässä; 0 tarkoittaa inaktiivista sairautta ja teoreettinen enimmäispistemäärä on 105. PGA on visuaalinen analoginen asteikko 0-3 (0 = ei mitään, 1 = lievä, 2 = kohtalainen, 3 = vaikea). BILAG-leimaus arvioidaan kullekin 9 elinalueelle; A on voimakas leimahdus ja B on kohtalainen. Osallistujat, jotka eivät kyenneet noudattamaan sallittuja samanaikaisten lääkkeiden vaatimuksia, katsottiin ei-vastettaviksi, samoin kuin osallistujat, jotka keskeyttivät tai puuttuivat viikon 52 tiedot. |
52 viikkoa
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Lauantai 1. tammikuuta 2011
Ensisijainen valmistuminen (TODELLINEN)
Perjantai 1. elokuuta 2014
Opintojen valmistuminen (TODELLINEN)
Sunnuntai 1. maaliskuuta 2015
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 17. syyskuuta 2010
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Perjantai 17. syyskuuta 2010
Ensimmäinen Lähetetty (ARVIO)
Maanantai 20. syyskuuta 2010
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (TODELLINEN)
Tiistai 17. heinäkuuta 2018
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 18. kesäkuuta 2018
Viimeksi vahvistettu
Perjantai 1. kesäkuuta 2018
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 13653
- H9B-MC-BCDT (MUUTA: Eli Lilly and Company)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .