A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
11 juni 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
1164
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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, Belarus, 224027
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Grodno, Belarus, 230017
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Minsk, Belarus, 220116
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Plovdiv, Bulgarien, 4002
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Sofia, Bulgarien, 1612
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Stara Zagora, Bulgarien, 6003
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Varna, Bulgarien, 9010
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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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Al Minya, Egypten, 61111
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Alexandria, Egypten, 21131
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Cairo, Egypten, 941400
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Angeles City, Filippinerna, 2009
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Cebu, Filippinerna, 6000
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Davao City, Filippinerna, 8000
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Ermita, Filippinerna, 1000
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Espana, Filippinerna, 1008
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Iloilo City, Filippinerna, 5000
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Manila, Filippinerna, 1007
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Paranaque, Filippinerna
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Quezon City, Filippinerna, 1102
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
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Arizona
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Glendale, Arizona, Förenta staterna, 85304
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Mesa, Arizona, Förenta staterna, 85202
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Paradise Valley, Arizona, Förenta staterna, 85253
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Peoria, Arizona, Förenta staterna, 85381
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Phoenix, Arizona, Förenta staterna, 85037
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
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California
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Anaheim, California, Förenta staterna, 92805
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Glendale, California, Förenta staterna, 91204
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Lakewood, California, Förenta staterna, 90712
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Long Beach, California, Förenta staterna, 90808
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Los Angeles, California, Förenta staterna, 90048
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Sacramento, California, Förenta staterna, 95825
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San Leandro, California, Förenta staterna, 94578
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Upland, California, Förenta staterna, 91786
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Connecticut
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Danbury, Connecticut, Förenta staterna, 06810
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Farmington, Connecticut, Förenta staterna, 06030
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Norwich, Connecticut, Förenta staterna, 06360
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Trumbull, Connecticut, Förenta staterna, 06611
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Florida
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Boca Raton, Florida, Förenta staterna, 33486
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Clearwater, Florida, Förenta staterna, 33765
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Doral, Florida, Förenta staterna, 33166
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Fort Lauderdale, Florida, Förenta staterna, 33334
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Jacksonville, Florida, Förenta staterna, 32216
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Lake Mary, Florida, Förenta staterna, 32746
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Miami, Florida, Förenta staterna, 33169
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Orange Park, Florida, Förenta staterna, 32073
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Palm Harbor, Florida, Förenta staterna, 34684
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Saint Petersburg, Florida, Förenta staterna, 33710
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Tamarac, Florida, Förenta staterna, 33321
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Tampa, Florida, Förenta staterna, 33612
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Georgia
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Atlanta, Georgia, Förenta staterna, 30342
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Decatur, Georgia, Förenta staterna, 30033
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Marietta, Georgia, Förenta staterna, 30060
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Idaho
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Boise, Idaho, Förenta staterna, 83702
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
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Peoria, Illinois, Förenta staterna, 61636
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Indiana
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Muncie, Indiana, Förenta staterna, 47304
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160
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Kentucky
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Bowling Green, Kentucky, Förenta staterna, 42101
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Lexington, Kentucky, Förenta staterna, 40504
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Maryland
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Baltimore, Maryland, Förenta staterna, 21239
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Hagerstown, Maryland, Förenta staterna, 21742
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Wheaton, Maryland, Förenta staterna, 20902
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Michigan
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Grand Rapids, Michigan, Förenta staterna, 49546
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Minnesota
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Eagan, Minnesota, Förenta staterna, 55121
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Missouri
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Florissant, Missouri, Förenta staterna, 63031
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Nebraska
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Lincoln, Nebraska, Förenta staterna, 68516
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Omaha, Nebraska, Förenta staterna, 68134
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New Jersey
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Clifton, New Jersey, Förenta staterna, 07012
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Teaneck, New Jersey, Förenta staterna, 07666
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Toms River, New Jersey, Förenta staterna, 08755
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87102
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New York
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Bronx, New York, Förenta staterna, 10457
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Endwell, New York, Förenta staterna, 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, Förenta staterna, 11030
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York, New York, Förenta staterna, 10019
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Rochester, New York, Förenta staterna, 14618
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Greenville, North Carolina, Förenta staterna, 27834
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Hickory, North Carolina, Förenta staterna, 28602
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45229
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Middleburg Heights, Ohio, Förenta staterna, 44130
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Oklahoma
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Edmond, Oklahoma, Förenta staterna, 73013
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Oklahoma City, Oklahoma, Förenta staterna, 73103
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19107
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Pittsburgh, Pennsylvania, Förenta staterna, 15217
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Willow Grove, Pennsylvania, Förenta staterna, 19090
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South Carolina
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Columbia, South Carolina, Förenta staterna, 29204
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Greenville, South Carolina, Förenta staterna, 29601
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North Charleston, South Carolina, Förenta staterna, 29406
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Tennessee
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Crossville, Tennessee, Förenta staterna, 38555
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Hixon, Tennessee, Förenta staterna, 37343
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Jackson, Tennessee, Förenta staterna, 38305
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Texas
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Allen, Texas, Förenta staterna, 75013
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Dallas, Texas, Förenta staterna, 75390
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Houston, Texas, Förenta staterna, 77034
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Irving, Texas, Förenta staterna, 75061
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Mesquite, Texas, Förenta staterna, 75150
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San Antonio, Texas, Förenta staterna, 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, Förenta staterna, 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, Förenta staterna, 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, Förenta staterna, 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, Förenta staterna, 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, Förenta staterna, 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, Förenta staterna, 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, Förenta staterna, 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, Förenta staterna, 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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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, Italien, 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, Italien, 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, Italien, 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, Italien, 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, Italien, 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, Italien, 90127
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Scafati, Italien, 84018
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Torino, Italien, 10128
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Aichi, Japan, 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, Japan, 284-0003
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Fukuoka, Japan, 807-8556
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Hokkaido, Japan, 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, Japan, 852-8501
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Miyagi, Japan, 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, Japan, 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, Japan, 530-8480
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Tokyo, Japan, 101-0062
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British Columbia
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Kelowna, British Columbia, Kanada, V1Y3G5
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ontario
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Markham, Ontario, Kanada, L3P1A8
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Newmarket, Ontario, Kanada, L3Y3R7
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bucheon, Korea, Republiken av, 420-717
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Daegu, Korea, Republiken av, 700-712
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Daejeon, Korea, Republiken av, 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, Korea, Republiken av, 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, Korea, Republiken av, 405-760
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jeonju-Si, Korea, Republiken av, 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, Korea, Republiken av, 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, Korea, Republiken av, 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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Osijek, Kroatien, 31000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bitola, Makedonien, fd jugoslaviska republiken, 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, Makedonien, fd jugoslaviska republiken, 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, Makedonien, fd jugoslaviska republiken, 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
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Peru, 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, 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?, Polen, 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, Polen, 41-902
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Poznan, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Singapore, 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, Thailand, 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, Thailand, 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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Bad Nauheim, Tyskland, 61231
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Baden-Baden, Tyskland, 76530
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Berlin, Tyskland, 14059
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Erlangen, Tyskland, 91054
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Freiburg, Tyskland, 79106
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hildesheim, Tyskland, 31134
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jena, Tyskland, 07747
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zerbst, Tyskland, 39261
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, Ukraina, 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, Ukraina, 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, Ukraina, 61029
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Kryvyi Rih, Ukraina, 50056
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Kyiv, Ukraina, 1601
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Lviv, Ukraina, 79011
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Odesa, Ukraina, 65025
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Simferopol, Ukraina, 95017
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Ternopil, Ukraina, 46002
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Uzhorod, Ukraina, 88018
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Vinnytsya, Ukraina, 21018
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Zaporizhzhia, Ukraina, 69600
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Zhytomyr, Ukraina, 10002
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Graz, Österrike, 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.
-
Vienna, Österrike, 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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo
Administreras SC
|
Andra namn:
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
|
|
Experimentell: 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.
Andra namn:
|
|
Experimentell: 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.
Andra namn:
Administreras via subkutan injektion i 52 veckor.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Andel deltagare som uppnår ett SLE-svarsindexsvar vid vecka 52
Tidsram: 52 veckor
|
Andel deltagare med ≥ 5 poängs minskning från baslinjen i SELENA SLEDAI-poäng och ingen försämring (ökning med < 0,30 poäng från baslinjen) i PGA, och ingen ny BILAG A-organdomänpoäng eller 2 nya BILAG B-organdomänpoäng jämfört med baslinjen . SELENA SLEDAI beräknas från 24 individuella deskriptorer över 9 organsystem; 0 indikerar inaktiv sjukdom och den maximala teoretiska poängen är 105; poäng > 20 är sällsynta. PGA är en visuell analog skala med poäng från 0 till 3 (0=ingen, 1=lindrig, 2=måttlig, 3=svår). BILAG använder en enda poäng för var och en av de 9 organdomänerna; intervallet är från svår (A) till ingen sjukdom (E). Deltagare som inte kunde uppfylla kraven på tillåtna samtidiga mediciner ansågs inte svara, liksom deltagare som hoppade av eller saknade data från vecka 52. |
52 veckor
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
Tidsram: 52 weeks
|
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.
|
52 weeks
|
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Ändring från baslinje till 52 veckor i nivån av antidubbelsträngad deoxiribonukleinsyra (Anti-dsDNA)
Tidsram: Baslinje, 52 veckor
|
Antidubbelsträngad deoxiribonukleinsyra (anti-dsDNA) är en laboratorieanalyt som används för att hjälpa till vid diagnosen SLE.
|
Baslinje, 52 veckor
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Förändring från baslinje till 52 veckors slutpunkt i systemisk lupus erythematosus sjukdoms aktivitetsindex (SLEDAI2K) poäng
Tidsram: Baslinje, 52 veckor
|
SLE Disease Activity Index 2000 (SLEDAI-2K) poäng är ett viktat, kumulativt index för lupus sjukdomsaktivitet.
SLEDAI-2K beräknas från 24 individuella deskriptorer över 9 organsystem; 0 indikerar inaktiv sjukdom och den maximala teoretiska poängen är 105.
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Baslinje, 52 veckor
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Dags till första allvarliga SLE-flamma (SFI)
Tidsram: Baslinje till och med 52 veckor
|
SFI använder SELENA-SLEDAIs sjukdomsaktivitetsindexpoäng, sjukdomsaktivitetsscenarier, behandlingsförändringar och PGA för att definiera milda/måttliga och svåra flare. Indexet tar hänsyn till den absoluta förändringen av totalpoäng, nya eller förvärrade symtom och ökningar av kortikosteroidanvändning eller sjukhusvistelse på grund av sjukdomsaktiviteten. Tid till första allvarliga SLE-uppblossning (SFI) (i dagar) beräknas som: (Startdatum för första allvarliga SLE-uppblossning (SFI) - Datum för randomisering + 1). |
Baslinje till och med 52 veckor
|
|
Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
Tidsram: 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.
|
52 weeks
|
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Ändring från baslinje till 52 veckors slutpunkt i kortfattad trötthetsinventering (BFI)
Tidsram: Baslinje, 52 veckor
|
En deltagarrapporterad skala som mäter trötthetens svårighetsgrad baserat på den värsta tröttheten som upplevts under de senaste 24 timmarna.
Allvarlighetspoängen varierade från 0 (ingen trötthet) till 10 (trötthet så allvarlig som du kan föreställa dig).
|
Baslinje, 52 veckor
|
|
Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
Tidsram: 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.
|
Baseline, 52 weeks
|
|
Dags för första New British Isles Lupus Assessment Group (BILAG A) eller 2 nya BILAG B SLE-bloss
Tidsram: Baslinje till och med 52 veckor
|
Instrumentet British Isles Lupus Assessment Group (BILAG) bedömer global sjukdomsaktivitet över 9 organsystemdomäner. BILAG flare bedöms för var och en av de 9 organdomänerna med hjälp av BILAG2004 index flare regler; A är ett kraftigt bloss och B är ett måttligt bloss. Tid till första BILAG A eller två BILAG B-bloss (i dagar) beräknas som: (Startdatum för första BILAG A eller två BILAG B-bloss - Datum för randomisering + 1). De två BILAG B-blossarna måste inträffa i olika domäner vid samma besök. |
Baslinje till och med 52 veckor
|
|
Change From Baseline to 52 Week Endpoint in PGA
Tidsram: 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.
|
Baseline, 52 weeks
|
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Andel deltagare med en ökning av kortikosteroiddosen vid 52 veckor
Tidsram: 52 veckor
|
En ökning av kortikosteroider vid ett besök definierades som en förändring från baslinjen större än 2,5 mg/dag i dos eller prednison eller motsvarande med användning av genomsnittlig daglig dos av kortikosteroider som tagits sedan det tidigare planerade besöket.
|
52 veckor
|
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Ändring från baslinje till 52 veckors slutpunkt i SELENA-SLEDAI sjukdomsaktivitetsresultat
Tidsram: Baslinje, 52 veckor
|
Säkerhet för östrogener i Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) poäng är ett viktat, kumulativt index för lupus sjukdomsaktivitet.
SELENA-SLEDAI beräknas från 24 individuella deskriptorer över 9 organsystem; 0 indikerar inaktiv sjukdom och den maximala teoretiska poängen är 105.
|
Baslinje, 52 veckor
|
|
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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2010
Primärt slutförande (Faktisk)
1 juli 2014
Avslutad studie (Faktisk)
1 juni 2015
Studieregistreringsdatum
Först inskickad
3 september 2010
Först inskickad som uppfyllde QC-kriterierna
3 september 2010
Första postat (Uppskatta)
8 september 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juni 2018
Senast verifierad
1 juni 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Lupus erythematosus, systemisk
- Bindvävssjukdomar
- Autoimmuna sjukdomar
- Läkemedels fysiologiska effekter
- Anti-infektionsmedel
- Agenter från det perifera nervsystemet
- Analgetika
- Sensoriska systemagenter
- Analgetika, icke-narkotiska
- Antireumatiska medel
- Immunologiska faktorer
- Antiprotozomedel
- Antiparasitära medel
- Antiinflammatoriska medel
- Immunsuppressiva medel
- Antiinflammatoriska medel, icke-steroida
- Antimalariamedel
Andra studie-ID-nummer
- 13656
- H9B-MC -BCDS (Annan identifierare: Eli Lilly and Company)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .