Een studie van LY2127399 bij deelnemers met systemische lupus erythematosus
18 juni 2018 bijgewerkt door: Eli Lilly and Company
Een multicenter, gerandomiseerde, dubbelblinde, placebogecontroleerde fase 3-studie om de werkzaamheid en veiligheid van subcutane LY2127399 te evalueren bij patiënten met systemische lupus erythematosus (SLE)
Het doel van deze SLE-studie is het evalueren van de werkzaamheid, veiligheid en verdraagbaarheid van twee verschillende doses LY2127399 die worden toegediend naast de standaardbehandeling bij deelnemers met actieve SLE.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1124
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Malvern East, Australië, 3145
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New South Wales
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St Leonards, New South Wales, Australië, 2065
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Queensland
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Cairns, Queensland, Australië, 4870
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Maroochydore, Queensland, Australië, 4558
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Victoria
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Clayton, Victoria, Australië, 3168
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Heidelberg, Victoria, Australië, 3081
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Campinas, Brazilië, 13015-011
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Goiania, Brazilië, 74110-120
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Juiz De Fora, Brazilië, 36010-570
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Porto Alegre, Brazilië, 91350-200
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Salvador, Brazilië, 40050-410
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São Paulo, Brazilië, 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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Orleans, Frankrijk, 45000
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Strasbourg, Frankrijk, 67091
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Budapest, Hongarije, 1027
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Debrecen, Hongarije, 4032
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Gyor, Hongarije, 9023
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Gyula, Hongarije, 5700
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Szeged, Hongarije, 6720
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Bangalore, Indië, 560043
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Gujarat, Indië, 380015
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Haryana, Indië, 122001
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Hyderabaad, Indië, 500082
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Kormangala, Indië, 560034
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Pune, Indië, 411007
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Trivandrum, Indië, 695011
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Haifa, Israël, 34362
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Kfar Saba, Israël, 44281
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Petah Tikva, Israël, 49100
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Tel Hashomer, Israël, 52651
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Zerifin, Israël, 70300
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Riga, Letland, LV-1002
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Kota Kinabalu, Maleisië, 88586
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Kuala Lumpur, Maleisië, 59100
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Guadalajara, Mexico, 44650
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Merida, Mexico, 97130
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Mexico City, Mexico, 06090
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San Luis, Mexico, 78240
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San Luis Potosi, Mexico, 78200
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Tijuana, Mexico, 22010
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Hamilton, Nieuw-Zeeland, 3204
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Otahuhu, Nieuw-Zeeland, 1640
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Takapuna, Nieuw-Zeeland, 622
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Brasov, Roemenië, 500283
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Bucharest, Roemenië, 020475
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Cluj-Napoca, Roemenië, 400006
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Galati, Roemenië, 800587
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Iasi, Roemenië, 700656
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Targu Mures, Roemenië, 540136
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Chelyabinsk, Russische Federatie, 454076
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Ekaterinburg, Russische Federatie, 620012
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Kazan, Russische Federatie, 420097
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Kemerovo, Russische Federatie, 650099
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Moscow, Russische Federatie, 125101
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Orenburg, Russische Federatie, 460018
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Saint Petersburg, Russische Federatie, 197089
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Tomsk, Russische Federatie, 634063
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Yaroslavl, Russische Federatie, 150023
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Belgrade, Servië, 11000
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Kragujevac, Servië, 34000
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Niska Banja, Servië, 18205
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Novi Sad, Servië, 21000
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Barcelona, Spanje, 08035
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Bilbao, Spanje, 48013
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La Coruña, Spanje, 15006
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Las Palmas De Gran Canaria, Spanje, 35010
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Madrid, Spanje, 28040
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Málaga, Spanje, 29010
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Santiago De Compostela, Spanje, 15706
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Sevilla, Spanje, 41071
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Vigo, Spanje, 36200
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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, Tunesië, 2070
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Monastir, Tunesië, 5000
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Sfax, Tunesië, 3029
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Sousse, Tunesië, 4000
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Tunis, Tunesië, 1008
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Tunis Monfleury, Tunesië, 1008
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London, Verenigd Koninkrijk, SE1 7EH
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Cambridgeshire
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Cambridge, Cambridgeshire, Verenigd Koninkrijk, 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, Verenigd Koninkrijk, 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, Verenigd Koninkrijk, E11 1NR
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kent
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Maidstone, Kent, Verenigd Koninkrijk, ME16 9QQ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lancashire
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Wigan, Lancashire, Verenigd Koninkrijk, 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, Verenigde Staten, 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, Verenigde Staten, 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
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Gilbert, Arizona, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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
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Aurora, Colorado, Verenigde Staten, 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
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Washington, District of Columbia, Verenigde Staten, 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
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Aventura, Florida, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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.
-
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Georgia
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Atlanta, Georgia, Verenigde Staten, 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, Verenigde Staten, 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.
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Lithonia, Georgia, Verenigde Staten, 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
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Meridian, Idaho, Verenigde Staten, 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
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Chicago, Illinois, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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.
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Indianapolis, Indiana, Verenigde Staten, 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
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Monroe, Louisiana, Verenigde Staten, 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
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Portland, Maine, Verenigde Staten, 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
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Cumberland, Maryland, Verenigde Staten, 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, Verenigde Staten, 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
-
Duluth, Minnesota, Verenigde Staten, 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, Verenigde Staten, 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.
-
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Missouri
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Saint Louis, Missouri, Verenigde Staten, 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
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Las Vegas, Nevada, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 11576
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 27804
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 43606
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Pennsylvania
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Duncansville, Pennsylvania, Verenigde Staten, 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, Verenigde Staten, 19610
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29425
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Tennessee
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Cookeville, Tennessee, Verenigde Staten, 38501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Knoxville, Tennessee, Verenigde Staten, 37909
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Memphis, Tennessee, Verenigde Staten, 38163
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nashville, Tennessee, Verenigde Staten, 37203
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Amarillo, Texas, Verenigde Staten, 79124
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Austin, Texas, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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, Verenigde Staten, 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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Cape Town, Zuid-Afrika, 7925
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Durban, Zuid-Afrika, 4001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Stellenbosch, Zuid-Afrika, 7600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (VOLWASSEN, OUDER_ADULT)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusiecriteria:
- Klinische diagnose van SLE zoals gedefinieerd door criteria van het American College of Rheumatology (ACR).
- Heb positieve antinucleaire antilichamen (ANA)
- Spreek af om tijdens de proef niet zwanger te worden
- Een screening SELENA-SLEDAI-score ≥6 hebben. (De deelnemer moet actief alle symptomen vertonen die op de SELENA-SLEDAI-screening zijn gescoord op de dag van de screening.)
Uitsluitingscriteria:
- Heb een actieve ernstige lupus-nierziekte
- Een actief centraal zenuwstelsel of perifere neurologische aandoening hebben
- Binnen 180 dagen na randomisatie intraveneus immunoglobuline (IVIg) hebben gekregen
- Heb een actieve of recente infectie binnen 30 dagen na screening
- Binnen 90 dagen na randomisatie een ernstige infectie hebben gehad
- Heb bewijs of test positief voor Hepatitis B
- Hepatitis C hebben
- Zijn humaan immunodeficiëntievirus (HIV) positief
- Bewijs hebben van actieve of latente tuberculose (tbc)
- Aanwezigheid van significante laboratoriumafwijkingen bij screening
- In de afgelopen 5 jaar een maligniteit hebben gehad, met uitzondering van in-situ cervicaal carcinoom of basaalcel- of plaveiselcelepitheelhuidcellen die volledig zijn gereseceerd zonder opnieuw op te treden in de 3 jaar voorafgaand aan randomisatie
- In de afgelopen 30 dagen meer dan 40 mg prednison of equivalent hebben gekregen
- Uw dosis antimalariamiddel in de afgelopen 30 dagen heeft veranderd
- Uw dosis van uw immunosuppressivum in de afgelopen 90 dagen heeft veranderd
- eerder rituximab hebben gekregen
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: BEHANDELING
- Toewijzing: GERANDOMISEERD
- Interventioneel model: PARALLEL
- Masker: VERVIERVOUDIGEN
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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PLACEBO_COMPARATOR: Placebo
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Toegediend via subcutane injectie gedurende 52 weken.
Bij de eerste dosis zal ook een bijpassende oplaaddosis worden toegediend.
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EXPERIMENTEEL: LY2127399 elke 2 weken
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120 mg toegediend via subcutane injectie gedurende 52 weken.
Een oplaaddosis van 240 mg zal worden toegediend als de eerste dosis van het onderzoeksgeneesmiddel
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EXPERIMENTEEL: LY2127399 elke 4 weken
Tijdens de behandelingsperiode wisselen de deelnemers om de twee weken injecties met LY2127399 en injecties met placebo af om blindheid te voorkomen.
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Toegediend via subcutane injectie gedurende 52 weken.
120 mg toegediend via subcutane injectie gedurende 52 weken.
Een oplaaddosis van 240 mg zal worden toegediend als de eerste dosis van het onderzoeksgeneesmiddel
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage deelnemers dat een respons op de SLE-responderindex behaalt in week 52
Tijdsspanne: 52 weken
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Percentage deelnemers met een afname van ≥ 5 punten ten opzichte van baseline in de SELENA SLEDAI-score, en geen verslechtering (toename van < 0,30 punten ten opzichte van baseline) in PGA, en geen nieuwe BILAG A-orgaandomeinscore of 2 nieuwe BILAG B-orgaandomeinscores vergeleken met baseline . SELENA SLEDAI wordt berekend op basis van 24 individuele descriptoren over 9 orgaansystemen; 0 geeft inactieve ziekte aan en de maximale theoretische score is 105; scores > 20 zijn zeldzaam. PGA is een visuele analoge schaal met een score van 0 tot 3 (0=geen, 1=mild, 2=matig, 3=ernstig). BILAG gebruikt één partituur voor elk van de 9 orgaandomeinen; bereik is van ernstig (A) tot geen ziekte (E). Deelnemers die niet in staat waren om te voldoen aan de toegestane vereisten voor gelijktijdige medicatie, werden beschouwd als non-responders, evenals deelnemers die stopten of gegevens over week 52 misten. |
52 weken
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Verandering van baseline naar 52 weken in anti-dubbelstrengs deoxyribonucleïnezuur (anti-dsDNA) niveau
Tijdsspanne: Basislijn, 52 weken
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Anti-dubbelstrengs deoxyribonucleïnezuur (anti-dsDNA) is een laboratoriumanalyt dat wordt gebruikt om te helpen bij de diagnose van SLE.
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Basislijn, 52 weken
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Verandering van basislijn naar eindpunt na 52 weken in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K)-score
Tijdsspanne: Basislijn, 52 weken
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SLE Disease Activity Index 2000 (SLEDAI-2K)-score is een gewogen, cumulatieve index van lupusziekteactiviteit.
SLEDAI-2K wordt berekend op basis van 24 individuele descriptoren over 9 orgaansystemen; 0 geeft inactieve ziekte aan en de maximale theoretische score is 105.
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Basislijn, 52 weken
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Tijd tot eerste ernstige SLE-flare (SFI)
Tijdsspanne: Basislijn tot en met 52 weken
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De SFI gebruikt de SELENA-SLEDAI ziekteactiviteitsindexscore, ziekteactiviteitsscenario's, behandelingsveranderingen en PGA om milde/matige en ernstige opflakkeringen te definiëren. De index houdt rekening met de absolute verandering in totaalscores, nieuwe of verslechterende symptomen en toenames in het gebruik van corticosteroïden of ziekenhuisopnames als gevolg van de ziekteactiviteit. De tijd tot de eerste ernstige SLE-flare (SFI) (in dagen) wordt berekend als: (Startdatum van de eerste ernstige SLE-flare (SFI) - Datum van randomisatie + 1). |
Basislijn tot en met 52 weken
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Wijziging van basislijn naar eindpunt na 52 weken in Short Fatigue Inventory (BFI)-scores
Tijdsspanne: Basislijn, 52 weken
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Een door deelnemers gerapporteerde schaal die de ernst van vermoeidheid meet op basis van de ergste vermoeidheid die de afgelopen 24 uur is ervaren.
De ernstscores varieerden van 0 (geen vermoeidheid) tot 10 (vermoeidheid zo ernstig als u zich kunt voorstellen).
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Basislijn, 52 weken
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Tijd tot eerste New British Isles Lupus Assessment Group (BILAG A) of 2 nieuwe BILAG B SLE fakkels
Tijdsspanne: Basislijn tot en met 52 weken
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Het instrument van de British Isles Lupus Assessment Group (BILAG) beoordeelt de wereldwijde ziekteactiviteit in 9 orgaansysteemdomeinen. BILAG flare wordt beoordeeld voor elk van de 9 orgaandomeinen met behulp van BILAG2004 index flare-regels; A is een ernstige overstraling en B is een matige overstraling. De tijd tot de eerste BILAG A- of twee BILAG B-fakkels (in dagen) wordt berekend als: (Startdatum van de eerste BILAG A- of twee BILAG B-fakkels - Datum van randomisatie + 1). De twee BILAG B-fakkels moeten tijdens hetzelfde bezoek in verschillende domeinen voorkomen. |
Basislijn tot en met 52 weken
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Percentage deelnemers met een verhoging van de dosis corticosteroïden na 52 weken
Tijdsspanne: 52 weken
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Een verhoging van het aantal corticosteroïden tijdens een bezoek werd gedefinieerd als een verandering ten opzichte van de uitgangswaarde van meer dan 2,5 mg/dag in dosis of prednison of equivalent bij gebruik van de gemiddelde dagelijkse dosis corticosteroïden ingenomen sinds het vorige geplande bezoek.
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52 weken
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Verandering van basislijn naar 52 weken eindpunt in SELENA-SLEDAI ziekteactiviteitsscore
Tijdsspanne: Basislijn, 52 weken
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Veiligheid van oestrogenen bij lupus erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI)-score is een gewogen, cumulatieve index van lupusziekteactiviteit.
SELENA-SLEDAI wordt berekend op basis van 24 individuele descriptoren over 9 orgaansystemen; 0 geeft inactieve ziekte aan en de maximale theoretische score is 105.
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Basislijn, 52 weken
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Percentage deelnemers dat de dosis prednison of equivalent kan verlagen zonder toename van de ziekteactiviteit in week 52
Tijdsspanne: 52 weken
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Een deelnemer behaalt corticosteroïdsparende effecten (rustige ziekte) als hij in week 24 tot en met 52 aan de volgende criteria heeft voldaan; in staat zijn om hun dosis prednison of equivalent te verlagen tot 7,5 mg/dag of minder, een rustige ziekte hebben (BILAG C-score of beter in alle negen systemen), en geen BILAG A- of B-opflakkeringen in de voorgaande drie maanden, zonder toename van een van beide antimalariamiddelen of immunosuppressiva op of voorafgaand aan het bezoek.
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52 weken
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Verandering van basislijn naar eindpunt na 52 weken in Physician's Global Assessment (PGA)
Tijdsspanne: Basislijn, 52 weken
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PGA is een single-item door een arts beoordeelde beoordeling van het huidige niveau van ziekteactiviteit van de deelnemer, gemeten op een continue 100-millimeter (mm) visuele analytische schaal met benchmarks van 0, 1, 2 en 3 van links naar rechts, overeenkomend met nee, mild , matige en ernstige SLE-ziekteactiviteit.
Scores worden gepresenteerd van 0 tot 100.
Geen verslechtering gedefinieerd als een toename van ≤ 0,30 punten ten opzichte van de uitgangswaarde.
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Basislijn, 52 weken
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Verandering van baseline naar 52 weken eindpunt Lupus Quality of Life (LupusQOL) domeinscores
Tijdsspanne: Basislijn, 52 weken
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De LupusQoL is een ziektespecifieke zelfrapportagevragenlijst met 34 items die is ontworpen om de gezondheidsgerelateerde kwaliteit van leven (HRQoL) van deelnemers met SLE binnen 8 domeinen te meten. De antwoorden zijn gebaseerd op een 5-punts Likert-schaal waarbij 0 ( de hele tijd) tot 4 (nooit).
Een LupusQoL-score voor elk domein wordt gerapporteerd op een schaal van 0 tot 100, waarbij hogere waarden een betere HRQoL aangeven.
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Basislijn, 52 weken
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Percentage deelnemers zonder verslechtering van de Physician Global Assessment (PGA)-score na 52 weken
Tijdsspanne: 52 weken
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Physician's Global Assessment (PGA) is een door een arts beoordeelde beoordeling met één item van het huidige niveau van ziekteactiviteit van de deelnemer, gemeten op een continue 100-mm visuele analytische schaal met benchmarks van 0, 1, 2 en 3 van links naar rechts, overeenkomend met geen , milde, matige en ernstige SLE-ziekteactiviteit.
Scores worden weergegeven van 0 tot 100. Geen verslechtering gedefinieerd als een toename van ≤ 0,30 punten ten opzichte van de uitgangswaarde.
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52 weken
|
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Aantal deelnemers zonder nieuwe BILAG A en niet meer dan één nieuwe BILAG B Ziekteactiviteitsscores vergeleken met baseline
Tijdsspanne: Basislijn tot en met 52 weken
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Het instrument van de British Isles Lupus Assessment Group (BILAG) beoordeelt de wereldwijde ziekteactiviteit in 9 orgaansysteemdomeinen.
BILAG flare wordt beoordeeld voor elk van de 9 orgaandomeinen met behulp van BILAG2004 index flare-regels; A is een ernstige overstraling en B is een matige overstraling.
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Basislijn tot en met 52 weken
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Percentage deelnemers dat een respons behaalt, zoals gemeten door gemodificeerde SRI zonder BILAG A of niet meer dan 1 BILAG B orgaandomeinuitbarstingen na 52 weken
Tijdsspanne: 52 weken
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Percentage deelnemers met een afname van ≥ 5 punten ten opzichte van baseline in de SELENA SLEDAI-score, en geen verslechtering (toename van < 0,30 punten ten opzichte van baseline) in PGA, en geen nieuwe BILAG A of niet meer dan 1 nieuwe BILAG B-orgaandomeinflare vergeleken met baseline . (Primaire uitkomst aangepast om BILAG-flare te gebruiken in plaats van BILAG-ziektescore) SELENA SLEDAI wordt berekend op basis van 24 individuele descriptoren over 9 orgaansystemen; 0 geeft inactieve ziekte aan en de maximale theoretische score is 105. PGA is een visuele analoge schaal met een score van 0 tot 3 (0=geen, 1=mild, 2=matig, 3=ernstig). BILAG-flare wordt beoordeeld voor elk van de 9 orgaandomeinen; A is een ernstige overstraling en B is een matige overstraling. Deelnemers die niet in staat waren om te voldoen aan de toegestane vereisten voor gelijktijdige medicatie, werden beschouwd als non-responders, evenals deelnemers die stopten of gegevens over week 52 misten. |
52 weken
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2011
Primaire voltooiing (WERKELIJK)
1 augustus 2014
Studie voltooiing (WERKELIJK)
1 maart 2015
Studieregistratiedata
Eerst ingediend
17 september 2010
Eerst ingediend dat voldeed aan de QC-criteria
17 september 2010
Eerst geplaatst (SCHATTING)
20 september 2010
Updates van studierecords
Laatste update geplaatst (WERKELIJK)
17 juli 2018
Laatste update ingediend die voldeed aan QC-criteria
18 juni 2018
Laatst geverifieerd
1 juni 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13653
- H9B-MC-BCDT (ANDER: Eli Lilly and Company)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .