Uno studio di LY2127399 nei partecipanti con lupus eritematoso sistemico
18 giugno 2018 aggiornato da: Eli Lilly and Company
Uno studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di LY2127399 sottocutaneo in pazienti con lupus eritematoso sistemico (LES)
Lo scopo di questo studio sul LES è valutare l'efficacia, la sicurezza e la tollerabilità di due diverse dosi di LY2127399 somministrate in aggiunta alla terapia standard di cura nei partecipanti con LES attivo.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1124
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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, Brasile, 13015-011
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Goiania, Brasile, 74110-120
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Juiz De Fora, Brasile, 36010-570
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Porto Alegre, Brasile, 91350-200
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Salvador, Brasile, 40050-410
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São Paulo, Brasile, 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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Cuenca, Ecuador, EC010150
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Guayaquil, Ecuador, 90110321
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Quito, Ecuador, 17
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Chelyabinsk, Federazione Russa, 454076
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Ekaterinburg, Federazione Russa, 620012
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Kazan, Federazione Russa, 420097
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Kemerovo, Federazione Russa, 650099
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Moscow, Federazione Russa, 125101
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Orenburg, Federazione Russa, 460018
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Saint Petersburg, Federazione Russa, 197089
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Tomsk, Federazione Russa, 634063
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Yaroslavl, Federazione Russa, 150023
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Orleans, Francia, 45000
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Strasbourg, Francia, 67091
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Bangalore, India, 560043
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Gujarat, India, 380015
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Haryana, India, 122001
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Hyderabaad, India, 500082
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Kormangala, India, 560034
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Pune, India, 411007
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Trivandrum, India, 695011
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Haifa, Israele, 34362
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Kfar Saba, Israele, 44281
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Petah Tikva, Israele, 49100
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Tel Hashomer, Israele, 52651
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Zerifin, Israele, 70300
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Riga, Lettonia, LV-1002
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Kota Kinabalu, Malaysia, 88586
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Kuala Lumpur, Malaysia, 59100
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Guadalajara, Messico, 44650
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Merida, Messico, 97130
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Mexico City, Messico, 06090
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San Luis, Messico, 78240
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San Luis Potosi, Messico, 78200
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Tijuana, Messico, 22010
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Hamilton, Nuova Zelanda, 3204
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Otahuhu, Nuova Zelanda, 1640
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Takapuna, Nuova Zelanda, 622
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London, Regno Unito, SE1 7EH
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Cambridgeshire
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Cambridge, Cambridgeshire, Regno Unito, CB2 0QQ
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Dorset
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Poole, Dorset, Regno Unito, BH15 2JB
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Greater London
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London, Greater London, Regno Unito, E11 1NR
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Kent
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Maidstone, Kent, Regno Unito, ME16 9QQ
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Lancashire
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Wigan, Lancashire, Regno Unito, WN6 0LW
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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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Barcelona, Spagna, 08035
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Bilbao, Spagna, 48013
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La Coruña, Spagna, 15006
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Las Palmas De Gran Canaria, Spagna, 35010
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Madrid, Spagna, 28040
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Málaga, Spagna, 29010
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Santiago De Compostela, Spagna, 15706
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Sevilla, Spagna, 41071
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Vigo, Spagna, 36200
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Alabama
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Anniston, Alabama, Stati Uniti, 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, Stati Uniti, 35216
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Arizona
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Gilbert, Arizona, Stati Uniti, 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, Stati Uniti, 85258
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Tempe, Arizona, Stati Uniti, 85282
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arkansas
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Malvern, Arkansas, Stati Uniti, 72104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Covina, California, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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.
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Riverside, California, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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.
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Santa Barbara, California, Stati Uniti, 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.
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Van Nuys, California, Stati Uniti, 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.
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Westlake Village, California, Stati Uniti, 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.
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Whittier, California, Stati Uniti, 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.
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Colorado
-
Aurora, Colorado, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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.
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DeBary, Florida, Stati Uniti, 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.
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Miami, Florida, Stati Uniti, 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.
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Naples, Florida, Stati Uniti, 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.
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New Port Richey, Florida, Stati Uniti, 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.
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Ormond Beach, Florida, Stati Uniti, 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.
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Pensacola, Florida, Stati Uniti, 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.
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Pinellas Park, Florida, Stati Uniti, 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.
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Plantation, Florida, Stati Uniti, 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.
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South Miami, Florida, Stati Uniti, 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.
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Tampa, Florida, Stati Uniti, 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.
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Vero Beach, Florida, Stati Uniti, 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, Stati Uniti, 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.
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Duluth, Georgia, Stati Uniti, 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, Stati Uniti, 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.
-
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Idaho
-
Meridian, Idaho, Stati Uniti, 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.
-
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Illinois
-
Chicago, Illinois, Stati Uniti, 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.
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Rockford, Illinois, Stati Uniti, 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.
-
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Indiana
-
Fort Wayne, Indiana, Stati Uniti, 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.
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Granger, Indiana, Stati Uniti, 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, Stati Uniti, 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.
-
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Louisiana
-
Monroe, Louisiana, Stati Uniti, 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.
-
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Maine
-
Portland, Maine, Stati Uniti, 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.
-
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Maryland
-
Cumberland, Maryland, Stati Uniti, 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.
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Michigan
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Saint Clair Shores, Michigan, Stati Uniti, 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.
-
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Minnesota
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Duluth, Minnesota, Stati Uniti, 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.
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Mississippi
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Hattiesburg, Mississippi, Stati Uniti, 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, Stati Uniti, 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.
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Nevada
-
Las Vegas, Nevada, Stati Uniti, 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.
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New Hampshire
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Nashua, New Hampshire, Stati Uniti, 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.
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New Jersey
-
Freehold, New Jersey, Stati Uniti, 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, Stati Uniti, 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
-
Las Cruces, New Mexico, Stati Uniti, 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
-
Albany, New York, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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
-
Chapel Hill, North Carolina, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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
-
Cincinnati, Ohio, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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
-
Duncansville, Pennsylvania, Stati Uniti, 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, Stati Uniti, 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
-
Charleston, South Carolina, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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, Stati Uniti, 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.
-
Nassau Bay, Texas, Stati Uniti, 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.
-
Round Rock, Texas, Stati Uniti, 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.
-
San Antonio, Texas, Stati Uniti, 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.
-
Victoria, Texas, Stati Uniti, 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, Stati Uniti, 84790
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Washington
-
Seattle, Washington, Stati Uniti, 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.
-
Spokane, Washington, Stati Uniti, 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, Stati Uniti, 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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-
-
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Cape Town, Sud Africa, 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.
-
Durban, Sud Africa, 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, Sud Africa, 7600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Changhua, Taiwan, 500
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hualien, Taiwan, 970
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kaohsiung, Taiwan, 833
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung, Taiwan, 40705
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung City, Taiwan, 40201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taipei, Taiwan, 10630
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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La Marsa, Tunisia, 2070
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Monastir, Tunisia, 5000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sfax, Tunisia, 3029
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sousse, Tunisia, 4000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tunis, Tunisia, 1008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tunis Monfleury, Tunisia, 1008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Budapest, Ungheria, 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, Ungheria, 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, Ungheria, 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, Ungheria, 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, Ungheria, 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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (ADULTO, ANZIANO_ADULTO)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Criterio di inclusione:
- Diagnosi clinica di LES come definito dai criteri dell'American College of Rheumatology (ACR).
- Avere anticorpi antinucleari positivi (ANA)
- Accetta di non rimanere incinta durante il corso del processo
- Avere un punteggio di screening SELENA-SLEDAI ≥6. (Il partecipante deve mostrare attivamente tutti i sintomi segnati sullo screening SELENA-SLEDAI il giorno dello screening.)
Criteri di esclusione:
- Avere una grave malattia renale Lupus attiva
- Avere un sistema nervoso centrale attivo o una malattia neurologica periferica
- - Hanno ricevuto immunoglobuline per via endovenosa (IVIg) entro 180 giorni dalla randomizzazione
- Avere un'infezione attiva o recente entro 30 giorni dallo screening
- - Hanno avuto un'infezione grave entro 90 giorni dalla randomizzazione
- Avere evidenza o test positivo per l'epatite B
- Avere l'epatite C
- Sono positivi al virus dell'immunodeficienza umana (HIV).
- Avere evidenza di tubercolosi attiva o latente (TBC)
- Presenza di significative anomalie di laboratorio allo screening
- Hanno avuto un tumore maligno negli ultimi 5 anni, ad eccezione del carcinoma cervicale in situ o delle cellule basali o epiteliali squamose che sono state completamente resecate senza recidive nei 3 anni precedenti la randomizzazione
- Hanno ricevuto più di 40 mg di prednisone o equivalente negli ultimi 30 giorni
- Hai cambiato la tua dose di farmaco antimalarico negli ultimi 30 giorni
- Hai cambiato la dose del farmaco immunosoppressore negli ultimi 90 giorni
- Hanno ricevuto in precedenza rituximab
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: TRATTAMENTO
- Assegnazione: RANDOMIZZATO
- Modello interventistico: PARALLELO
- Mascheramento: QUADRUPLICARE
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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PLACEBO_COMPARATORE: Placebo
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Somministrato tramite iniezione sottocutanea per 52 settimane.
Alla prima dose verrà somministrata anche una dose di carico corrispondente.
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SPERIMENTALE: LY2127399 ogni 2 settimane
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120 mg somministrati tramite iniezione sottocutanea per 52 settimane.
La dose di carico di 240 mg verrà somministrata come prima dose del farmaco oggetto dello studio
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SPERIMENTALE: LY2127399 ogni 4 settimane
Durante il periodo di trattamento, a scopo di accecamento, i partecipanti alterneranno iniezioni di LY2127399 e iniezioni di placebo ogni 2 settimane.
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Somministrato tramite iniezione sottocutanea per 52 settimane.
120 mg somministrati tramite iniezione sottocutanea per 52 settimane.
La dose di carico di 240 mg verrà somministrata come prima dose del farmaco oggetto dello studio
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentuale di partecipanti che hanno ottenuto una risposta all'indice di risposta SLE alla settimana 52
Lasso di tempo: 52 settimane
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Percentuale di partecipanti con una riduzione ≥ 5 punti rispetto al basale nel punteggio SELENA SLEDAI e nessun peggioramento (aumento di <0,30 punti rispetto al basale) nel PGA e nessun nuovo punteggio del dominio degli organi BILAG A o 2 nuovi punteggi del dominio degli organi BILAG B rispetto al basale . SELENA SLEDAI è calcolato da 24 descrittori individuali in 9 sistemi di organi; 0 indica malattia inattiva e il massimo punteggio teorico è 105; i punteggi > 20 sono rari. PGA è una scala analogica visiva con punteggio da 0 a 3 (0=nessuno, 1=lieve, 2=moderato, 3=grave). BILAG utilizza un singolo punteggio per ciascuno dei 9 domini degli organi; l'intervallo va da grave (A) a nessuna malattia (E). I partecipanti che non erano in grado di rispettare i requisiti di farmaci concomitanti consentiti sono stati considerati non-responder, così come i partecipanti che hanno abbandonato o mancavano i dati della Settimana 52. |
52 settimane
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Variazione dal basale a 52 settimane del livello di acido desossiribonucleico a doppia elica (Anti-dsDNA)
Lasso di tempo: Basale, 52 settimane
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L'acido desossiribonucleico anti-doppio filamento (anti-dsDNA) è un analita di laboratorio utilizzato per assistere nella diagnosi di LES.
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Basale, 52 settimane
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Variazione dal basale all'endpoint a 52 settimane nel punteggio dell'indice di attività della malattia del lupus eritematoso sistemico (SLEDAI2K)
Lasso di tempo: Basale, 52 settimane
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Il punteggio SLE Disease Activity Index 2000 (SLEDAI-2K) è un indice cumulativo ponderato dell'attività della malattia del lupus.
SLEDAI-2K è calcolato da 24 descrittori individuali in 9 sistemi di organi; 0 indica malattia inattiva e il punteggio teorico massimo è 105.
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Basale, 52 settimane
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Tempo alla prima grave riacutizzazione del LES (SFI)
Lasso di tempo: Basale per 52 settimane
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Lo SFI utilizza il punteggio dell'indice di attività della malattia SELENA-SLEDAI, gli scenari di attività della malattia, i cambiamenti del trattamento e il PGA per definire le riacutizzazioni lievi/moderate e gravi. L'indice tiene conto della variazione assoluta dei punteggi totali, dei sintomi nuovi o in peggioramento e dell'aumento dell'uso di corticosteroidi o dell'ospedalizzazione a causa dell'attività della malattia. Il tempo alla prima grave riacutizzazione di SLE (SFI) (in giorni) è calcolato come: (Data di inizio della prima grave riacutizzazione di SLE (SFI) - Data di randomizzazione + 1). |
Basale per 52 settimane
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Modifica dal basale all'endpoint di 52 settimane nei punteggi del Brief Fatigue Inventory (BFI).
Lasso di tempo: Basale, 52 settimane
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Una scala riportata dai partecipanti che misura la gravità dell'affaticamento in base all'affaticamento peggiore sperimentato nelle ultime 24 ore.
I punteggi di gravità variavano da 0 (nessuna fatica) a 10 (fatica così grave come puoi immaginare).
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Basale, 52 settimane
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Tempo per il primo gruppo di valutazione del lupus delle nuove isole britanniche (BILAG A) o 2 nuovi BILAG B SLE Flare
Lasso di tempo: Basale per 52 settimane
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Lo strumento BILAG (British Isles Lupus Assessment Group) valuta l'attività globale della malattia in 9 domini di sistemi di organi. Il bagliore BILAG viene valutato per ciascuno dei 9 domini degli organi utilizzando le regole del bagliore dell'indice BILAG2004; A è una grave riacutizzazione e B è una moderata riacutizzazione. Il tempo per il primo BILAG A o due BILAG B flare (in giorni) è calcolato come segue: (Data di inizio del primo BILAG A o due BILAG B flare - Data di randomizzazione + 1). I due brillamenti BILAG B devono verificarsi in domini diversi durante la stessa visita. |
Basale per 52 settimane
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Percentuale di partecipanti con un aumento della dose di corticosteroidi a 52 settimane
Lasso di tempo: 52 settimane
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Un aumento dei corticosteroidi durante una visita è stato definito come una variazione rispetto al basale superiore a 2,5 mg/die nella dose o prednisone o equivalente utilizzando la dose giornaliera media di corticosteroidi assunta dalla precedente visita programmata.
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52 settimane
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Modifica dall'endpoint basale a 52 settimane nel punteggio di attività della malattia SELENA-SLEDAI
Lasso di tempo: Basale, 52 settimane
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Il punteggio Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) è un indice cumulativo ponderato dell'attività della malattia del lupus.
SELENA-SLEDAI è calcolato da 24 descrittori individuali in 9 sistemi di organi; 0 indica malattia inattiva e il punteggio teorico massimo è 105.
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Basale, 52 settimane
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Percentuale di partecipanti in grado di ridurre la dose di prednisone o equivalente senza alcun aumento dell'attività della malattia alla settimana 52
Lasso di tempo: 52 settimane
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Un partecipante ottiene effetti di risparmio di corticosteroidi (malattia quiescente) se ha soddisfatto i seguenti criteri durante le settimane da 24 a 52; in grado di ridurre la loro dose di prednisone o equivalente a 7,5 mg/die o meno, hanno una malattia quiescente (punteggio BILAG C o migliore in tutti e nove i sistemi) e nessuna riacutizzazione BILAG A o B nei tre mesi precedenti, senza un aumento di entrambi antimalarici o immunosoppressori durante o prima della visita.
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52 settimane
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Modifica dall'endpoint basale a 52 settimane nella valutazione globale del medico (PGA)
Lasso di tempo: Basale, 52 settimane
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PGA è una valutazione valutata da un medico a un singolo elemento dell'attuale livello di attività della malattia del partecipante misurata su una scala analitica visiva continua di 100 millimetri (mm) con punti di riferimento di 0, 1, 2 e 3 da sinistra a destra corrispondenti a no, lieve , moderata e grave attività della malattia LES.
I punteggi sono presentati da 0 a 100.
Nessun peggioramento definito come aumento di ≤ 0,30 punti rispetto al basale.
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Basale, 52 settimane
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Modifica dei punteggi del dominio Lupus Quality of Life (LupusQOL) dall'endpoint di 52 settimane all'endpoint basale
Lasso di tempo: Basale, 52 settimane
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Il LupusQoL è un questionario self-report di 34 voci specifico per la malattia, progettato per misurare la qualità della vita correlata alla salute (HRQoL) dei partecipanti con LES all'interno di 8 domini. Le risposte si basano su una scala Likert a 5 punti in cui 0 ( sempre) a 4 (mai).
Un punteggio LupusQoL per ciascun dominio è riportato su una scala da 0 a 100, con valori maggiori che indicano una migliore HRQoL.
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Basale, 52 settimane
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Percentuale di partecipanti senza peggioramento del punteggio Physician Global Assessment (PGA) a 52 settimane
Lasso di tempo: 52 settimane
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Physician's Global Assessment (PGA) è una valutazione valutata da un medico a un singolo elemento dell'attuale livello di attività della malattia del partecipante misurata su una scala analitica visiva continua di 100 mm con punti di riferimento di 0, 1, 2 e 3 da sinistra a destra corrispondenti a no , attività della malattia del LES lieve, moderata e grave.
I punteggi sono presentati da 0 a 100. Nessun peggioramento definito come aumento di ≤ 0,30 punti rispetto al basale.
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52 settimane
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Numero di partecipanti senza nuovi punteggi di attività della malattia BILAG A e non più di un nuovo BILAG B rispetto al basale
Lasso di tempo: Basale per 52 settimane
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Lo strumento BILAG (British Isles Lupus Assessment Group) valuta l'attività globale della malattia in 9 domini di sistemi di organi.
Il bagliore BILAG viene valutato per ciascuno dei 9 domini degli organi utilizzando le regole del bagliore dell'indice BILAG2004; A è una grave riacutizzazione e B è una moderata riacutizzazione.
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Basale per 52 settimane
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Percentuale di partecipanti che hanno ottenuto una risposta misurata dall'SRI modificato senza BILAG A o non più di 1 BILAG B Organ Domain Flares a 52 settimane
Lasso di tempo: 52 settimane
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Percentuale di partecipanti con una riduzione ≥ 5 punti rispetto al basale nel punteggio SELENA SLEDAI e nessun peggioramento (aumento di <0,30 punti rispetto al basale) in PGA e nessun nuovo BILAG A o non più di 1 nuovo BILAG B flare del dominio dell'organo rispetto al basale . (Risultato primario modificato per utilizzare la riacutizzazione BILAG invece del punteggio della malattia BILAG) SELENA SLEDAI è calcolato da 24 descrittori individuali in 9 sistemi di organi; 0 indica malattia inattiva e il punteggio teorico massimo è 105. PGA è una scala analogica visiva con punteggio da 0 a 3 (0=nessuno, 1=lieve, 2=moderato, 3=grave). Il bagliore BILAG viene valutato per ciascuno dei 9 domini degli organi; A è una grave riacutizzazione e B è una moderata riacutizzazione. I partecipanti che non erano in grado di rispettare i requisiti di farmaci concomitanti consentiti sono stati considerati non-responder, così come i partecipanti che hanno abbandonato o mancavano i dati della Settimana 52. |
52 settimane
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2011
Completamento primario (EFFETTIVO)
1 agosto 2014
Completamento dello studio (EFFETTIVO)
1 marzo 2015
Date di iscrizione allo studio
Primo inviato
17 settembre 2010
Primo inviato che soddisfa i criteri di controllo qualità
17 settembre 2010
Primo Inserito (STIMA)
20 settembre 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (EFFETTIVO)
17 luglio 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 giugno 2018
Ultimo verificato
1 giugno 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 13653
- H9B-MC-BCDT (ALTRO: Eli Lilly and Company)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .