A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
11 июня 2018 г. обновлено: Eli Lilly and Company
A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in participants with active SLE.
Обзор исследования
Статус
Завершенный
Тип исследования
Интервенционный
Регистрация (Действительный)
1164
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Graz, Австрия, 8036
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Vienna, Австрия, A1090
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Buenos Aires, Аргентина, C1417EYG
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Caba, Аргентина, C1181ACH
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Córdoba, Аргентина, X5016KEH
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Rosario, Аргентина, S2000PBJ
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San Juan, Аргентина, 5400
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Tucuman, Аргентина, 4000
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Brest, Беларусь, 224027
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Grodno, Беларусь, 230017
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Minsk, Беларусь, 220116
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Plovdiv, Болгария, 4002
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Sofia, Болгария, 1612
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Stara Zagora, Болгария, 6003
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Varna, Болгария, 9010
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Guatemala, Гватемала, 1010
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Bad Nauheim, Германия, 61231
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Baden-Baden, Германия, 76530
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Berlin, Германия, 14059
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Erlangen, Германия, 91054
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Freiburg, Германия, 79106
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Hildesheim, Германия, 31134
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Jena, Германия, 07747
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Zerbst, Германия, 39261
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Al Minya, Египет, 61111
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Alexandria, Египет, 21131
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Cairo, Египет, 941400
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Brescia, Италия, 25123
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Genova, Италия, 16132
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Milano, Италия, 20122
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Napoli, Италия, 80131
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Padova, Италия, 35128
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Palermo, Италия, 90127
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Scafati, Италия, 84018
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Torino, Италия, 10128
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British Columbia
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Kelowna, British Columbia, Канада, V1Y3G5
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Ontario
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Markham, Ontario, Канада, L3P1A8
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Newmarket, Ontario, Канада, L3Y3R7
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Bogota, Колумбия
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Bucaramanga, Колумбия, 681001
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Cali, Колумбия
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Chia, Колумбия
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Medellín, Колумбия, 574
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Bucheon, Корея, Республика, 420-717
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Daegu, Корея, Республика, 700-712
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Daejeon, Корея, Республика, 301-721
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Gwangju, Корея, Республика, 501-757
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Incheon, Корея, Республика, 405-760
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Jeonju-Si, Корея, Республика, 561712
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Seoul, Корея, Республика, 143-729
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Suwon, Корея, Республика, 443-721
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Bitola, Македония, Бывшая Югославская Республика, 7000
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Skopje, Македония, Бывшая Югославская Республика, 1000
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Stip, Македония, Бывшая Югославская Республика, 2000
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Arequipa, Перу
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Lima, Перу, L41
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Lince, Перу, Lima14
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Piura, Перу
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?Ód?, Польша, 94-017
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Bytom, Польша, 41-902
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Poznan, Польша, 61-397
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Sosnowiec, Польша, 41-200
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Warsaw, Польша, 02-507
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Wroc?Aw, Польша, 50-368
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San Juan, Пуэрто-Рико, 00918
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Santurce, Пуэрто-Рико, 00909
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Singapore, Сингапур, 258499
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Alabama
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Birmingham, Alabama, Соединенные Штаты, 35294
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Arizona
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Glendale, Arizona, Соединенные Штаты, 85304
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Mesa, Arizona, Соединенные Штаты, 85202
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Paradise Valley, Arizona, Соединенные Штаты, 85253
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Peoria, Arizona, Соединенные Штаты, 85381
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Phoenix, Arizona, Соединенные Штаты, 85037
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Arkansas
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Little Rock, Arkansas, Соединенные Штаты, 72205
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California
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Anaheim, California, Соединенные Штаты, 92805
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Glendale, California, Соединенные Штаты, 91204
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Lakewood, California, Соединенные Штаты, 90712
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Long Beach, California, Соединенные Штаты, 90808
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Los Angeles, California, Соединенные Штаты, 90048
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Sacramento, California, Соединенные Штаты, 95825
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San Leandro, California, Соединенные Штаты, 94578
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Upland, California, Соединенные Штаты, 91786
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Connecticut
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Danbury, Connecticut, Соединенные Штаты, 06810
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Farmington, Connecticut, Соединенные Штаты, 06030
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Norwich, Connecticut, Соединенные Штаты, 06360
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Trumbull, Connecticut, Соединенные Штаты, 06611
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Boca Raton, Florida, Соединенные Штаты, 33486
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Clearwater, Florida, Соединенные Штаты, 33765
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Doral, Florida, Соединенные Штаты, 33166
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fort Lauderdale, Florida, Соединенные Штаты, 33334
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jacksonville, Florida, Соединенные Штаты, 32216
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lake Mary, Florida, Соединенные Штаты, 32746
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Соединенные Штаты, 33169
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Orange Park, Florida, Соединенные Штаты, 32073
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Palm Harbor, Florida, Соединенные Штаты, 34684
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saint Petersburg, Florida, Соединенные Штаты, 33710
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tamarac, Florida, Соединенные Штаты, 33321
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Соединенные Штаты, 33612
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Соединенные Штаты, 30342
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Decatur, Georgia, Соединенные Штаты, 30033
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Marietta, Georgia, Соединенные Штаты, 30060
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Boise, Idaho, Соединенные Штаты, 83702
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Соединенные Штаты, 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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Peoria, Illinois, Соединенные Штаты, 61636
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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
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Muncie, Indiana, Соединенные Штаты, 47304
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kansas
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Kansas City, Kansas, Соединенные Штаты, 66160
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kentucky
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Bowling Green, Kentucky, Соединенные Штаты, 42101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lexington, Kentucky, Соединенные Штаты, 40504
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Baltimore, Maryland, Соединенные Штаты, 21239
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hagerstown, Maryland, Соединенные Штаты, 21742
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wheaton, Maryland, Соединенные Штаты, 20902
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Grand Rapids, Michigan, Соединенные Штаты, 49546
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Eagan, Minnesota, Соединенные Штаты, 55121
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Florissant, Missouri, Соединенные Штаты, 63031
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nebraska
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Lincoln, Nebraska, Соединенные Штаты, 68516
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Omaha, Nebraska, Соединенные Штаты, 68134
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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
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Clifton, New Jersey, Соединенные Штаты, 07012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Teaneck, New Jersey, Соединенные Штаты, 07666
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toms River, New Jersey, Соединенные Штаты, 08755
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Mexico
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Albuquerque, New Mexico, Соединенные Штаты, 87102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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Bronx, New York, Соединенные Штаты, 10457
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Endwell, New York, Соединенные Штаты, 13760
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manhasset, New York, Соединенные Штаты, 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, Соединенные Штаты, 10019
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rochester, New York, Соединенные Штаты, 14618
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Charlotte, North Carolina, Соединенные Штаты, 28210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Greenville, North Carolina, Соединенные Штаты, 27834
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hickory, North Carolina, Соединенные Штаты, 28602
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Соединенные Штаты, 45229
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Middleburg Heights, Ohio, Соединенные Штаты, 44130
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Edmond, Oklahoma, Соединенные Штаты, 73013
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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 City, Oklahoma, Соединенные Штаты, 73103
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Philadelphia, Pennsylvania, Соединенные Штаты, 19107
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15217
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Willow Grove, Pennsylvania, Соединенные Штаты, 19090
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Columbia, South Carolina, Соединенные Штаты, 29204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Greenville, South Carolina, Соединенные Штаты, 29601
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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 Charleston, South Carolina, Соединенные Штаты, 29406
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Crossville, Tennessee, Соединенные Штаты, 38555
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hixon, Tennessee, Соединенные Штаты, 37343
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jackson, Tennessee, Соединенные Штаты, 38305
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Allen, Texas, Соединенные Штаты, 75013
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dallas, Texas, Соединенные Штаты, 75390
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Houston, Texas, Соединенные Штаты, 77034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Irving, Texas, Соединенные Штаты, 75061
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mesquite, Texas, Соединенные Штаты, 75150
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Соединенные Штаты, 78229
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sugar Land, Texas, Соединенные Штаты, 77478
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Waco, Texas, Соединенные Штаты, 76708
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Virginia
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Chesapeake, Virginia, Соединенные Штаты, 23320
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Danville, Virginia, Соединенные Штаты, 24541
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Richmond, Virginia, Соединенные Штаты, 23294
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Williamsburg, Virginia, Соединенные Штаты, 23185
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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Tacoma, Washington, Соединенные Штаты, 98405
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wisconsin
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Milwaukee, Wisconsin, Соединенные Штаты, 53226
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bangkok, Таиланд, 10700
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chiang Mai, Таиланд, 50200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Donetsk, Украина, 83001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ivano-Frankivsk, Украина, 76008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kharkiv, Украина, 61029
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kryvyi Rih, Украина, 50056
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kyiv, Украина, 1601
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lviv, Украина, 79011
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Odesa, Украина, 65025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Simferopol, Украина, 95017
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ternopil, Украина, 46002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Uzhorod, Украина, 88018
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vinnytsya, Украина, 21018
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zaporizhzhia, Украина, 69600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zhytomyr, Украина, 10002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Angeles City, Филиппины, 2009
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cebu, Филиппины, 6000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Davao City, Филиппины, 8000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ermita, Филиппины, 1000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Espana, Филиппины, 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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Iloilo City, Филиппины, 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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Manila, Филиппины, 1007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Paranaque, Филиппины
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Quezon City, Филиппины, 1102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osijek, Хорватия, 31000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osorno, Чили, 5290000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Santiago, Чили, 7500000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valdivia, Чили
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Aichi, Япония, 4600001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chiba, Япония, 284-0003
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fukuoka, Япония, 807-8556
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hokkaido, Япония, 060-8648
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Japan, Япония, 852-8501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Miyagi, Япония, 980-8574
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagasaki, Япония, 856-8562
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osaka, Япония, 530-8480
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokyo, Япония, 101-0062
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
- Have positive antinuclear antibodies (ANA)
- Agree not to become pregnant throughout the course of the trial
- Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)
Exclusion Criteria:
- Have active severe Lupus kidney disease
- Have active Central Nervous System or peripheral neurologic disease
- Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
- Have active or recent infection within 30 days of screening
- Have had a serious infection within 90 days of randomization
- Have evidence or test positive for Hepatitis B
- Have Hepatitis C
- Are human immunodeficiency virus (HIV) positive
- Have evidence of active or latent tuberculosis (TB)
- Presence of significant laboratory abnormalities at screening
- Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
- Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
- Have changed your dose of antimalarial drug in the past 30 days
- Have changed your dose of immunosuppressive drug in the past 90 days
- Have previously received rituximab
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Плацебо Компаратор: Плацебо
Администрируемый SC
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Другие имена:
Administered via subcutaneous injection for 52 weeks.
A matching loading dose of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose
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Экспериментальный: LY2127399 every 2 weeks
Administered SC
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120 mg administered via subcutaneous (SC) injection for 52 weeks.
240 mg loading dose will be administered as the first dose of study drug.
Другие имена:
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Экспериментальный: LY2127399 every 4 wks
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
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120 mg administered via subcutaneous (SC) injection for 52 weeks.
240 mg loading dose will be administered as the first dose of study drug.
Другие имена:
Вводят через подкожную инъекцию в течение 52 недель.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Процент участников, достигших индекса респондеров при СКВ на 52-й неделе
Временное ограничение: 52 недели
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Процент участников со снижением оценки SELENA SLEDAI на ≥ 5 баллов по сравнению с исходным уровнем и без ухудшения (увеличение <0,30 балла по сравнению с исходным уровнем) в PGA, а также без новой оценки домена органа BILAG A или 2 новых баллов домена органа BILAG B по сравнению с исходным уровнем . SELENA SLEDAI рассчитывается на основе 24 отдельных дескрипторов по 9 системам органов; 0 указывает на неактивное заболевание, а максимальный теоретический балл составляет 105; баллы > 20 встречаются редко. PGA — это визуальная аналоговая шкала, оцениваемая от 0 до 3 (0 = нет, 1 = легкая, 2 = умеренная, 3 = тяжелая). BILAG использует единую оценку для каждого из 9 доменов органов; диапазон от тяжелого (А) до отсутствия заболевания (Е). Участники, которые не могли соблюдать разрешенные требования к сопутствующим лекарствам, считались не ответившими, как и участники, которые выбыли или отсутствовали данные 52-й недели. |
52 недели
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
Временное ограничение: 52 weeks
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A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit.
Only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included.
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52 weeks
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Изменение уровня антител к двухцепочечной дезоксирибонуклеиновой кислоте (анти-дцДНК) по сравнению с исходным уровнем до 52 недель
Временное ограничение: Исходный уровень, 52 недели
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Антидвуцепочечная дезоксирибонуклеиновая кислота (анти-дцДНК) представляет собой лабораторный анализ, используемый для диагностики СКВ.
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Исходный уровень, 52 недели
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Изменение индекса активности системной красной волчанки (SLEDAI2K) от исходного уровня до конечной точки через 52 недели
Временное ограничение: Исходный уровень, 52 недели
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Индекс активности заболевания СКВ 2000 (SLEDAI-2K) представляет собой взвешенный кумулятивный индекс активности заболевания волчанкой.
SLEDAI-2K рассчитывается на основе 24 отдельных дескрипторов по 9 системам органов; 0 указывает на неактивное заболевание, а максимальный теоретический балл составляет 105.
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Исходный уровень, 52 недели
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Время до первой тяжелой вспышки СКВ (SFI)
Временное ограничение: Исходный уровень через 52 недели
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SFI использует индекс активности заболевания SELENA-SLEDAI, сценарии активности заболевания, изменения в лечении и PGA для определения легких/умеренных и тяжелых обострений. Индекс учитывает абсолютное изменение общего количества баллов, появление новых или ухудшение симптомов, а также увеличение использования кортикостероидов или госпитализации в связи с активностью заболевания. Время до первого тяжелого обострения СКВ (SFI) (в днях) рассчитывается как: (Дата начала первого тяжелого обострения SLE (SFI) - Дата рандомизации + 1). |
Исходный уровень через 52 недели
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Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
Временное ограничение: 52 weeks
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Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100 millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity.
Scores are presented from 0 to 100.
No worsening is defined as increase of ≥0.3 points.
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52 weeks
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Изменение показателей краткой инвентаризации усталости (BFI) по сравнению с исходным уровнем до 52-недельной конечной точки
Временное ограничение: Исходный уровень, 52 недели
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Шкала, сообщаемая участниками, которая измеряет тяжесть утомления на основе наибольшей утомляемости, испытанной за последние 24 часа.
Оценки тяжести варьировались от 0 (нет усталости) до 10 (усталость настолько сильна, насколько вы можете себе представить).
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Исходный уровень, 52 недели
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Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Временное ограничение: Baseline, 52 weeks
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The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never).
A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.
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Baseline, 52 weeks
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Время до первой новой группы по оценке волчанки на Британских островах (BILAG A) или 2 новых вспышек BILAG B SLE
Временное ограничение: Исходный уровень через 52 недели
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Инструмент Группы оценки волчанки Британских островов (BILAG) оценивает глобальную активность заболевания в 9 доменах системы органов. Вспышка BILAG оценивается для каждого из 9 доменов органов с использованием правил индекса вспышки BILAG2004; А — сильная вспышка, Б — умеренная вспышка. Время до первой вспышки BILAG A или двух вспышек BILAG B (в днях) рассчитывается как: (Дата начала первой вспышки BILAG A или двух вспышек BILAG B - Дата рандомизации + 1). Две вспышки BILAG B должны произойти в разных доменах в одно и то же посещение. |
Исходный уровень через 52 недели
|
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Change From Baseline to 52 Week Endpoint in PGA
Временное ограничение: Baseline, 52 weeks
|
Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity.
Scores range from 0, being worst possible to 100 being very active or best possible.
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Baseline, 52 weeks
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Процент участников с увеличением дозы кортикостероидов через 52 недели
Временное ограничение: 52 недели
|
Повышение уровня кортикостероидов во время визита определяли как изменение по сравнению с исходным уровнем более чем на 2,5 мг/сут в дозе преднизолона или его эквивалента с использованием средней суточной дозы кортикостероидов, принятой с момента предыдущего запланированного визита.
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52 недели
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Изменение по сравнению с исходным уровнем до конечной точки через 52 недели в шкале активности заболевания SELENA-SLEDAI
Временное ограничение: Исходный уровень, 52 недели
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Безопасность эстрогенов при красной волчанке Национальная оценка — индекс активности заболевания СКВ (SELENA-SLEDAI) представляет собой взвешенный кумулятивный индекс активности заболевания волчанкой.
SELENA-SLEDAI рассчитывается на основе 24 отдельных дескрипторов по 9 системам органов; 0 указывает на неактивное заболевание, а максимальный теоретический балл составляет 105.
|
Исходный уровень, 52 недели
|
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Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks
Временное ограничение: 52 weeks
|
Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score) SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Patients who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data. |
52 weeks
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Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline
Временное ограничение: Baseline through 52 weeks
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The BILAG2004 index is a validated global disease activity index designed on the basis of the physician's ITT, focusing on changes in disease manifestations (new, improved, worsening, etc) occurring in the last 4 weeks compared with the previous 4 weeks. The instrument assesses 97 clinical signs, symptoms, and laboratory parameters across 9 organ system domains: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, opthalmic, renal and hematology. |
Baseline through 52 weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
- Isenberg DA, Petri M, Kalunian K, Tanaka Y, Urowitz MB, Hoffman RW, Morgan-Cox M, Iikuni N, Silk M, Wallace DJ. Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):323-31. doi: 10.1136/annrheumdis-2015-207653. Epub 2015 Sep 3.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 декабря 2010 г.
Первичное завершение (Действительный)
1 июля 2014 г.
Завершение исследования (Действительный)
1 июня 2015 г.
Даты регистрации исследования
Первый отправленный
3 сентября 2010 г.
Впервые представлено, что соответствует критериям контроля качества
3 сентября 2010 г.
Первый опубликованный (Оценивать)
8 сентября 2010 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
12 июня 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
11 июня 2018 г.
Последняя проверка
1 июня 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания иммунной системы
- Красная волчанка, системная
- Заболевания соединительной ткани
- Аутоиммунные заболевания
- Физиологические эффекты лекарств
- Противоинфекционные агенты
- Агенты периферической нервной системы
- Анальгетики
- Агенты сенсорной системы
- Анальгетики, ненаркотические
- Противоревматические агенты
- Иммунологические факторы
- Противопротозойные агенты
- Противопаразитарные агенты
- Противовоспалительные агенты
- Иммунодепрессанты
- Противовоспалительные средства, нестероидные
- Противомалярийные
Другие идентификационные номера исследования
- 13656
- H9B-MC -BCDS (Другой идентификатор: Eli Lilly and Company)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
продукт, произведенный в США и экспортированный из США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .