A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
11 de junho de 2018 atualizado 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.
Visão geral do estudo
Status
Concluído
Tipo de estudo
Intervencional
Inscrição (Real)
1164
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bad Nauheim, Alemanha, 61231
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Baden-Baden, Alemanha, 76530
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Berlin, Alemanha, 14059
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Erlangen, Alemanha, 91054
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Freiburg, Alemanha, 79106
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Hildesheim, Alemanha, 31134
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Jena, Alemanha, 07747
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Zerbst, Alemanha, 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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Brest, Bielorrússia, 224027
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Grodno, Bielorrússia, 230017
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Minsk, Bielorrússia, 220116
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Plovdiv, Bulgária, 4002
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Sofia, Bulgária, 1612
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Stara Zagora, Bulgária, 6003
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Varna, Bulgária, 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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Singapore, Cingapura, 258499
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Bogota, Colômbia
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Bucaramanga, Colômbia, 681001
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Cali, Colômbia
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Chia, Colômbia
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Medellín, Colômbia, 574
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Osijek, Croácia, 31000
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Al Minya, Egito, 61111
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Alexandria, Egito, 21131
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Cairo, Egito, 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
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Missouri
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Florissant, Missouri, Estados Unidos, 63031
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68516
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Omaha, Nebraska, Estados Unidos, 68134
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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
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87102
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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
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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
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Pittsburgh, Pennsylvania, Estados Unidos, 15217
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Willow Grove, Pennsylvania, Estados Unidos, 19090
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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
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Hixon, Tennessee, Estados Unidos, 37343
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Jackson, Tennessee, Estados Unidos, 38305
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Texas
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Allen, Texas, Estados Unidos, 75013
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Dallas, Texas, Estados Unidos, 75390
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Houston, Texas, Estados Unidos, 77034
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Irving, Texas, Estados Unidos, 75061
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Mesquite, Texas, Estados Unidos, 75150
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San Antonio, Texas, Estados Unidos, 78229
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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
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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
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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
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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, Itália, 25123
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Genova, Itália, 16132
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Milano, Itália, 20122
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Napoli, Itália, 80131
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Padova, Itália, 35128
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Palermo, Itália, 90127
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Scafati, Itália, 84018
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Torino, Itália, 10128
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Aichi, Japão, 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, Japão, 284-0003
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Fukuoka, Japão, 807-8556
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Hokkaido, Japão, 060-8648
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Japan, Japão, 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, Japão, 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, Japão, 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, Japão, 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, Japão, 101-0062
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Bitola, Macedônia, Antiga República Iugoslava da, 7000
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Skopje, Macedônia, Antiga República Iugoslava da, 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, Macedônia, Antiga República Iugoslava da, 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, Peru
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Peru, L41
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Lince, Peru, Lima14
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Piura, Peru
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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?, Polônia, 94-017
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Bytom, Polônia, 41-902
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Poznan, Polônia, 61-397
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Sosnowiec, Polônia, 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, Polônia, 02-507
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Wroc?Aw, Polônia, 50-368
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San Juan, Porto Rico, 00918
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Santurce, Porto Rico, 00909
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Bucheon, Republica da Coréia, 420-717
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Daegu, Republica da Coréia, 700-712
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Daejeon, Republica da Coréia, 301-721
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gwangju, Republica da Coréia, 501-757
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Incheon, Republica da Coréia, 405-760
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Jeonju-Si, Republica da Coréia, 561712
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seoul, Republica da Coréia, 143-729
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Suwon, Republica da Coréia, 443-721
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Tailândia, 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, Tailândia, 50200
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Donetsk, Ucrânia, 83001
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Ivano-Frankivsk, Ucrânia, 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, Ucrânia, 61029
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Kryvyi Rih, Ucrânia, 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, Ucrânia, 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, Ucrânia, 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, Ucrânia, 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, Ucrânia, 95017
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Ternopil, Ucrânia, 46002
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Uzhorod, Ucrânia, 88018
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Vinnytsya, Ucrânia, 21018
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Zaporizhzhia, Ucrânia, 69600
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Zhytomyr, Ucrânia, 10002
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Graz, Áustria, 8036
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vienna, Áustria, A1090
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Placebo
SC administrado
|
Outros nomes:
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
|
120 mg administered via subcutaneous (SC) injection for 52 weeks.
240 mg loading dose will be administered as the first dose of study drug.
Outros nomes:
|
|
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.
|
120 mg administered via subcutaneous (SC) injection for 52 weeks.
240 mg loading dose will be administered as the first dose of study drug.
Outros nomes:
Administrado por injeção subcutânea por 52 semanas.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Porcentagem de participantes que obtiveram uma resposta de índice de resposta ao LES na semana 52
Prazo: 52 semanas
|
Porcentagem de participantes com redução ≥ 5 pontos desde o início no escore SELENA SLEDAI e sem piora (aumento de < 0,30 pontos desde o início) no PGA, e nenhum novo escore de domínio de órgão BILAG A ou 2 novos escores de domínio de órgão BILAG B em comparação com o basal . SELENA SLEDAI é calculado a partir de 24 descritores individuais em 9 sistemas de órgãos; 0 indica doença inativa e o escore teórico máximo é 105; pontuações > 20 são raras. PGA é uma escala analógica visual pontuada de 0 a 3 (0=nenhum, 1=leve, 2=moderado, 3=grave). O BILAG usa uma pontuação única para cada um dos 9 domínios de órgãos; varia de grave (A) a nenhuma doença (E). Os participantes que não conseguiram cumprir os requisitos de medicamentos concomitantes permitidos foram considerados não respondedores, assim como os participantes que desistiram ou não tinham dados da Semana 52. |
52 semanas
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
Prazo: 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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Mudança da linha de base para 52 semanas no nível de ácido desoxirribonucleico de cadeia dupla (Anti-dsDNA)
Prazo: Linha de base, 52 semanas
|
O anti-ácido desoxirribonucléico de cadeia dupla (anti-dsDNA) é um analito de laboratório usado para auxiliar no diagnóstico de LES.
|
Linha de base, 52 semanas
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Mudança da linha de base para o ponto final de 52 semanas na pontuação do índice de atividade da doença de lúpus eritematoso sistêmico (SLEDAI2K)
Prazo: Linha de base, 52 semanas
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A pontuação do SLE Disease Activity Index 2000 (SLEDAI-2K) é um índice cumulativo ponderado da atividade da doença lúpica.
SLEDAI-2K é calculado a partir de 24 descritores individuais em 9 sistemas de órgãos; 0 indica doença inativa e o escore teórico máximo é 105.
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Linha de base, 52 semanas
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Tempo para o primeiro surto grave de LES (SFI)
Prazo: Linha de base até 52 semanas
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O SFI usa a pontuação do índice de atividade da doença SELENA-SLEDAI, cenários de atividade da doença, mudanças no tratamento e PGA para definir surtos leves/moderados e graves. O índice leva em consideração a mudança absoluta nos escores totais, sintomas novos ou agravados e aumentos no uso de corticosteróides ou hospitalizações devido à atividade da doença. O tempo até o primeiro surto grave de LES (SFI) (em dias) é calculado como: (Data de início do primeiro surto grave de LES (SFI) - Data de randomização + 1). |
Linha de base até 52 semanas
|
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Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
Prazo: 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 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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Mudança da linha de base para o ponto final de 52 semanas nas pontuações do inventário breve de fadiga (BFI)
Prazo: Linha de base, 52 semanas
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Uma escala relatada pelos participantes que mede a gravidade da fadiga com base na pior fadiga experimentada nas últimas 24 horas.
As pontuações de gravidade variaram de 0 (sem fadiga) a 10 (fadiga tão grave quanto você pode imaginar).
|
Linha de base, 52 semanas
|
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Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Prazo: Baseline, 52 weeks
|
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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Tempo para o primeiro novo grupo de avaliação de lúpus das ilhas britânicas (BILAG A) ou 2 novos surtos de LES BILAG B
Prazo: Linha de base até 52 semanas
|
O instrumento British Isles Lupus Assessment Group (BILAG) avalia a atividade global da doença em 9 domínios de sistemas de órgãos. O flare BILAG é avaliado para cada um dos 9 domínios de órgãos usando as regras de flare do índice BILAG2004; A é uma erupção grave e B é uma erupção moderada. O tempo até a primeira explosão de BILAG A ou duas explosões de BILAG B (em dias) é calculado como: (Data de início da primeira explosão de BILAG A ou duas explosões de BILAG B - Data de randomização + 1). Os dois surtos BILAG B devem ocorrer em domínios diferentes na mesma visita. |
Linha de base até 52 semanas
|
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Change From Baseline to 52 Week Endpoint in PGA
Prazo: 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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Porcentagem de participantes com aumento na dose de corticosteróides em 52 semanas
Prazo: 52 semanas
|
Um aumento nos corticosteroides em uma visita foi definido como uma alteração da linha de base superior a 2,5 mg/dia na dose ou prednisona ou equivalente usando a dose diária média de corticosteroides ingeridos desde a consulta agendada anterior.
|
52 semanas
|
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Mudança da linha de base para o ponto final de 52 semanas na pontuação de atividade da doença SELENA-SLEDAI
Prazo: Linha de base, 52 semanas
|
Avaliação Nacional de Segurança de Estrogênios no Lúpus Eritematoso - Índice de Atividade da Doença do LES (SELENA-SLEDAI) é um índice cumulativo e ponderado da atividade da doença lúpica.
SELENA-SLEDAI é calculado a partir de 24 descritores individuais em 9 sistemas de órgãos; 0 indica doença inativa e o escore teórico máximo é 105.
|
Linha de base, 52 semanas
|
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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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2010
Conclusão Primária (Real)
1 de julho de 2014
Conclusão do estudo (Real)
1 de junho de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
3 de setembro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de setembro de 2010
Primeira postagem (Estimativa)
8 de setembro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de junho de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de junho de 2018
Última verificação
1 de junho de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do sistema imunológico
- Lúpus Eritematoso Sistêmico
- Doenças do Tecido Conjuntivo
- Doenças autoimunes
- Efeitos Fisiológicos das Drogas
- Agentes Anti-Infecciosos
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Analgésicos, Não Narcóticos
- Agentes Antirreumáticos
- Fatores imunológicos
- Agentes Antiprotozoários
- Antiparasitários
- Antiinflamatórios
- Agentes imunossupressores
- Agentes anti-inflamatórios não esteróides
- Antimaláricos
Outros números de identificação do estudo
- 13656
- H9B-MC -BCDS (Outro identificador: Eli Lilly and Company)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .