A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
11 de junio de 2018 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
1164
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bad Nauheim, Alemania, 61231
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Baden-Baden, Alemania, 76530
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Berlin, Alemania, 14059
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Erlangen, Alemania, 91054
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Freiburg, Alemania, 79106
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Hildesheim, Alemania, 31134
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Jena, Alemania, 07747
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Zerbst, Alemania, 39261
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Buenos Aires, Argentina, C1417EYG
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Caba, Argentina, C1181ACH
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Córdoba, Argentina, X5016KEH
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Rosario, Argentina, S2000PBJ
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San Juan, Argentina, 5400
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Tucuman, Argentina, 4000
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Graz, Austria, 8036
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Vienna, Austria, A1090
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Brest, Bielorrusia, 224027
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Grodno, Bielorrusia, 230017
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Minsk, Bielorrusia, 220116
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Plovdiv, Bulgaria, 4002
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Sofia, Bulgaria, 1612
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Stara Zagora, Bulgaria, 6003
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Varna, Bulgaria, 9010
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British Columbia
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Kelowna, British Columbia, Canadá, V1Y3G5
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Ontario
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Markham, Ontario, Canadá, L3P1A8
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Newmarket, Ontario, Canadá, L3Y3R7
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Osorno, Chile, 5290000
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Santiago, Chile, 7500000
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Valdivia, Chile
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Bogota, Colombia
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Bucaramanga, Colombia, 681001
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Cali, Colombia
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Chia, Colombia
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Medellín, Colombia, 574
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Bucheon, Corea, república de, 420-717
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Daegu, Corea, república de, 700-712
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Daejeon, Corea, república de, 301-721
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Gwangju, Corea, república de, 501-757
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Incheon, Corea, república de, 405-760
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Jeonju-Si, Corea, república de, 561712
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Seoul, Corea, república de, 143-729
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Suwon, Corea, república de, 443-721
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Osijek, Croacia, 31000
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Al Minya, Egipto, 61111
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Alexandria, Egipto, 21131
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Cairo, Egipto, 941400
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
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Arizona
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Glendale, Arizona, Estados Unidos, 85304
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Mesa, Arizona, Estados Unidos, 85202
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Paradise Valley, Arizona, Estados Unidos, 85253
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Peoria, Arizona, Estados Unidos, 85381
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Phoenix, Arizona, Estados Unidos, 85037
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
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California
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Anaheim, California, Estados Unidos, 92805
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Glendale, California, Estados Unidos, 91204
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Lakewood, California, Estados Unidos, 90712
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Long Beach, California, Estados Unidos, 90808
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Los Angeles, California, Estados Unidos, 90048
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Sacramento, California, Estados Unidos, 95825
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San Leandro, California, Estados Unidos, 94578
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Upland, California, Estados Unidos, 91786
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Connecticut
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Danbury, Connecticut, Estados Unidos, 06810
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Farmington, Connecticut, Estados Unidos, 06030
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Norwich, Connecticut, Estados Unidos, 06360
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Trumbull, Connecticut, Estados Unidos, 06611
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Florida
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Boca Raton, Florida, Estados Unidos, 33486
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Clearwater, Florida, Estados Unidos, 33765
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Doral, Florida, Estados Unidos, 33166
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Fort Lauderdale, Florida, Estados Unidos, 33334
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Jacksonville, Florida, Estados Unidos, 32216
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Lake Mary, Florida, Estados Unidos, 32746
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Miami, Florida, Estados Unidos, 33169
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Orange Park, Florida, Estados Unidos, 32073
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Palm Harbor, Florida, Estados Unidos, 34684
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Saint Petersburg, Florida, Estados Unidos, 33710
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Tamarac, Florida, Estados Unidos, 33321
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Tampa, Florida, Estados Unidos, 33612
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
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Decatur, Georgia, Estados Unidos, 30033
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Marietta, Georgia, Estados Unidos, 30060
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Idaho
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Boise, Idaho, Estados Unidos, 83702
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
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Peoria, Illinois, Estados Unidos, 61636
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Indiana
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Muncie, Indiana, Estados Unidos, 47304
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
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Kentucky
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Bowling Green, Kentucky, Estados Unidos, 42101
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Lexington, Kentucky, Estados Unidos, 40504
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Maryland
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Baltimore, Maryland, Estados Unidos, 21239
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Hagerstown, Maryland, Estados Unidos, 21742
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Wheaton, Maryland, Estados Unidos, 20902
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49546
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Minnesota
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Eagan, Minnesota, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 07012
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Teaneck, New Jersey, Estados Unidos, 07666
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Toms River, New Jersey, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 10457
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Endwell, New York, Estados Unidos, 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, Estados Unidos, 11030
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New York, New York, Estados Unidos, 10019
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Rochester, New York, Estados Unidos, 14618
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28210
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Greenville, North Carolina, Estados Unidos, 27834
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Hickory, North Carolina, Estados Unidos, 28602
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
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Middleburg Heights, Ohio, Estados Unidos, 44130
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Oklahoma
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Edmond, Oklahoma, Estados Unidos, 73013
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Oklahoma City, Oklahoma, Estados Unidos, 73103
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 29204
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Greenville, South Carolina, Estados Unidos, 29601
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North Charleston, South Carolina, Estados Unidos, 29406
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Tennessee
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Crossville, Tennessee, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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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Angeles City, Filipinas, 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, Filipinas, 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, Filipinas, 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, Filipinas, 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, Filipinas, 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, Filipinas, 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, Filipinas, 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, Filipinas
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Filipinas, 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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Guatemala, Guatemala, 1010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Brescia, Italia, 25123
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Genova, Italia, 16132
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Milano, Italia, 20122
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Napoli, Italia, 80131
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Padova, Italia, 35128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Palermo, Italia, 90127
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Scafati, Italia, 84018
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Torino, Italia, 10128
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Aichi, Japón, 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, Japón, 284-0003
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Fukuoka, Japón, 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, Japón, 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, Japón, 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, Japón, 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, Japón, 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, Japón, 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, Japón, 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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Bitola, Macedonia, la ex República Yugoslava de, 7000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Skopje, Macedonia, la ex República Yugoslava de, 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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Stip, Macedonia, la ex República Yugoslava de, 2000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arequipa, Perú
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lima, Perú, L41
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lince, Perú, Lima14
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Piura, Perú
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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?Ód?, Polonia, 94-017
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bytom, Polonia, 41-902
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Poznan, Polonia, 61-397
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sosnowiec, Polonia, 41-200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Warsaw, Polonia, 02-507
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wroc?Aw, Polonia, 50-368
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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 Juan, Puerto Rico, 00918
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Santurce, Puerto Rico, 00909
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Singapore, Singapur, 258499
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Tailandia, 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, Tailandia, 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, Ucrania, 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, Ucrania, 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, Ucrania, 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, Ucrania, 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, Ucrania, 1601
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Lviv, Ucrania, 79011
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Odesa, Ucrania, 65025
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Simferopol, Ucrania, 95017
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Ternopil, Ucrania, 46002
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Uzhorod, Ucrania, 88018
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Vinnytsya, Ucrania, 21018
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Zaporizhzhia, Ucrania, 69600
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Zhytomyr, Ucrania, 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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
CS administrado
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Otros nombres:
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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Experimental: 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.
Otros nombres:
|
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Experimental: 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.
Otros nombres:
Administrado mediante inyección subcutánea durante 52 semanas.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Porcentaje de participantes que lograron una respuesta del índice de respuesta SLE en la semana 52
Periodo de tiempo: 52 semanas
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Porcentaje de participantes con una reducción de ≥ 5 puntos desde el inicio en la puntuación SELENA SLEDAI y sin empeoramiento (aumento de < 0,30 puntos desde el inicio) en la PGA, y sin una nueva puntuación del dominio de órganos BILAG A o 2 nuevas puntuaciones del dominio de órganos BILAG B en comparación con el inicio . SELENA SLEDAI se calcula a partir de 24 descriptores individuales en 9 sistemas de órganos; 0 indica enfermedad inactiva y la puntuación teórica máxima es 105; las puntuaciones > 20 son raras. PGA es una escala analógica visual que se puntúa de 0 a 3 (0=ninguno, 1=leve, 2=moderado, 3=grave). BILAG utiliza una puntuación única para cada uno de los 9 dominios de órganos; el rango es de grave (A) a sin enfermedad (E). Los participantes que no pudieron cumplir con los requisitos de medicamentos concomitantes permitidos se consideraron no respondedores, al igual que los participantes que abandonaron o a los que les faltaban los datos de la Semana 52. |
52 semanas
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
Periodo de tiempo: 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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Cambio desde el inicio hasta las 52 semanas en el nivel de anti-ácido desoxirribonucleico de doble cadena (Anti-dsDNA)
Periodo de tiempo: Línea de base, 52 semanas
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El anti-ácido desoxirribonucleico de doble cadena (anti-dsDNA) es un analito de laboratorio que se utiliza para ayudar en el diagnóstico de LES.
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Línea de base, 52 semanas
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Cambio desde el inicio hasta el punto final de 52 semanas en la puntuación del índice de actividad de la enfermedad del lupus eritematoso sistémico (SLEDAI2K)
Periodo de tiempo: Línea de base, 52 semanas
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La puntuación del SLE Disease Activity Index 2000 (SLEDAI-2K) es un índice ponderado y acumulativo de la actividad de la enfermedad del lupus.
SLEDAI-2K se calcula a partir de 24 descriptores individuales en 9 sistemas de órganos; 0 indica enfermedad inactiva y la puntuación teórica máxima es 105.
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Línea de base, 52 semanas
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Tiempo hasta el primer brote severo de LES (SFI)
Periodo de tiempo: Línea de base hasta las 52 semanas
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El SFI utiliza la puntuación del índice de actividad de la enfermedad de SELENA-SLEDAI, escenarios de actividad de la enfermedad, cambios de tratamiento y PGA para definir brotes leves/moderados y graves. El índice tiene en cuenta el cambio absoluto en las puntuaciones totales, los síntomas nuevos o que empeoran y los aumentos en el uso de corticosteroides o la hospitalización debido a la actividad de la enfermedad. El tiempo hasta el primer brote grave de LES (SFI) (en días) se calcula como: (Fecha de inicio del primer brote grave de LES (SFI) - Fecha de aleatorización + 1). |
Línea de base hasta las 52 semanas
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Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
Periodo de tiempo: 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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Cambio desde el punto de referencia hasta el punto final de 52 semanas en las puntuaciones del Inventario Breve de Fatiga (BFI)
Periodo de tiempo: Línea de base, 52 semanas
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Una escala informada por los participantes que mide la gravedad de la fatiga en función de la peor fatiga experimentada durante las últimas 24 horas.
Los puntajes de gravedad variaron de 0 (sin fatiga) a 10 (fatiga tan severa como puedas imaginar).
|
Línea de base, 52 semanas
|
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Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Periodo de tiempo: 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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Tiempo hasta el primer nuevo grupo de evaluación de lupus de las Islas Británicas (BILAG A) o 2 brotes nuevos de BILAG B SLE
Periodo de tiempo: Línea de base hasta las 52 semanas
|
El instrumento del Grupo de Evaluación del Lupus de las Islas Británicas (BILAG) evalúa la actividad global de la enfermedad en 9 dominios de sistemas de órganos. Los brotes de BILAG se evalúan para cada uno de los 9 dominios de órganos utilizando las reglas del índice de brotes de BILAG2004; A es un brote severo y B es un brote moderado. El tiempo hasta el primer brote de BILAG A o dos brotes de BILAG B (en días) se calcula como: (Fecha de inicio del primer brote de BILAG A o dos brotes de BILAG B - Fecha de aleatorización + 1). Los dos brotes de BILAG B deben ocurrir en diferentes dominios en la misma visita. |
Línea de base hasta las 52 semanas
|
|
Change From Baseline to 52 Week Endpoint in PGA
Periodo de tiempo: 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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Porcentaje de participantes con un aumento en la dosis de corticosteroides a las 52 semanas
Periodo de tiempo: 52 semanas
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Un aumento en los corticosteroides en una visita se definió como un cambio desde el inicio superior a 2,5 mg/día en la dosis de prednisona o equivalente usando la dosis diaria promedio de corticosteroides tomada desde la visita programada anterior.
|
52 semanas
|
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Cambio desde el inicio hasta el punto final de 52 semanas en la puntuación de actividad de la enfermedad de SELENA-SLEDAI
Periodo de tiempo: Línea de base, 52 semanas
|
Evaluación nacional de la seguridad de los estrógenos en el lupus eritematoso: la puntuación del Índice de actividad de la enfermedad del LES (SELENA-SLEDAI) es un índice ponderado y acumulativo de la actividad de la enfermedad del lupus.
SELENA-SLEDAI se calcula a partir de 24 descriptores individuales en 9 sistemas de órganos; 0 indica enfermedad inactiva y la puntuación teórica máxima es 105.
|
Línea de base, 52 semanas
|
|
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
Periodo de tiempo: 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
|
|
Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline
Periodo de tiempo: Baseline through 52 weeks
|
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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2010
Finalización primaria (Actual)
1 de julio de 2014
Finalización del estudio (Actual)
1 de junio de 2015
Fechas de registro del estudio
Enviado por primera vez
3 de septiembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
3 de septiembre de 2010
Publicado por primera vez (Estimar)
8 de septiembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
11 de junio de 2018
Última verificación
1 de junio de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Lupus Eritematoso Sistémico
- Enfermedades del tejido conectivo
- Enfermedades autoinmunes
- Efectos fisiológicos de las drogas
- Agentes antiinfecciosos
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Analgésicos no narcóticos
- Agentes antirreumáticos
- Factores inmunológicos
- Agentes antiprotozoarios
- Agentes antiparasitarios
- Agentes antiinflamatorios
- Agentes inmunosupresores
- Agentes antiinflamatorios no esteroideos
- Antipalúdicos
Otros números de identificación del estudio
- 13656
- H9B-MC -BCDS (Otro identificador: Eli Lilly and Company)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .