A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
2018년 6월 11일 업데이트: 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.
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
1164
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Guatemala, 과테말라, 1010
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Bucheon, 대한민국, 420-717
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Daegu, 대한민국, 700-712
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Daejeon, 대한민국, 301-721
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Gwangju, 대한민국, 501-757
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Incheon, 대한민국, 405-760
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Jeonju-Si, 대한민국, 561712
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Seoul, 대한민국, 143-729
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Suwon, 대한민국, 443-721
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Bad Nauheim, 독일, 61231
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Baden-Baden, 독일, 76530
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Berlin, 독일, 14059
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Erlangen, 독일, 91054
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Freiburg, 독일, 79106
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Hildesheim, 독일, 31134
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Jena, 독일, 07747
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Zerbst, 독일, 39261
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Bitola, 마케도니아, 구 유고슬라비아 공화국, 7000
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Skopje, 마케도니아, 구 유고슬라비아 공화국, 1000
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Stip, 마케도니아, 구 유고슬라비아 공화국, 2000
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Alabama
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Birmingham, Alabama, 미국, 35294
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Arizona
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Glendale, Arizona, 미국, 85304
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Mesa, Arizona, 미국, 85202
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Paradise Valley, Arizona, 미국, 85253
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Peoria, Arizona, 미국, 85381
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Phoenix, Arizona, 미국, 85037
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Arkansas
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Little Rock, Arkansas, 미국, 72205
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California
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Anaheim, California, 미국, 92805
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Glendale, California, 미국, 91204
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Lakewood, California, 미국, 90712
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Long Beach, California, 미국, 90808
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Los Angeles, California, 미국, 90048
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Sacramento, California, 미국, 95825
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San Leandro, California, 미국, 94578
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Upland, California, 미국, 91786
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Connecticut
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Danbury, Connecticut, 미국, 06810
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Farmington, Connecticut, 미국, 06030
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Norwich, Connecticut, 미국, 06360
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Trumbull, Connecticut, 미국, 06611
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Florida
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Boca Raton, Florida, 미국, 33486
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Clearwater, Florida, 미국, 33765
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Doral, Florida, 미국, 33166
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Fort Lauderdale, Florida, 미국, 33334
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Jacksonville, Florida, 미국, 32216
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Lake Mary, Florida, 미국, 32746
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Miami, Florida, 미국, 33169
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Orange Park, Florida, 미국, 32073
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Palm Harbor, Florida, 미국, 34684
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Saint Petersburg, Florida, 미국, 33710
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Tamarac, Florida, 미국, 33321
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Tampa, Florida, 미국, 33612
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Georgia
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Atlanta, Georgia, 미국, 30342
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Decatur, Georgia, 미국, 30033
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Marietta, Georgia, 미국, 30060
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Idaho
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Boise, Idaho, 미국, 83702
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Illinois
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Chicago, Illinois, 미국, 60612
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Peoria, Illinois, 미국, 61636
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Indiana
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Muncie, Indiana, 미국, 47304
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Kansas
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Kansas City, Kansas, 미국, 66160
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Kentucky
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Bowling Green, Kentucky, 미국, 42101
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Lexington, Kentucky, 미국, 40504
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Maryland
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Baltimore, Maryland, 미국, 21239
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Hagerstown, Maryland, 미국, 21742
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Wheaton, Maryland, 미국, 20902
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Michigan
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Grand Rapids, Michigan, 미국, 49546
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Minnesota
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Eagan, Minnesota, 미국, 55121
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Missouri
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Florissant, Missouri, 미국, 63031
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Nebraska
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Lincoln, Nebraska, 미국, 68516
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Omaha, Nebraska, 미국, 68134
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New Jersey
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Clifton, New Jersey, 미국, 07012
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Teaneck, New Jersey, 미국, 07666
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Toms River, New Jersey, 미국, 08755
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New Mexico
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Albuquerque, New Mexico, 미국, 87102
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New York
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Bronx, New York, 미국, 10457
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Endwell, New York, 미국, 13760
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Manhasset, New York, 미국, 11030
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New York, New York, 미국, 10019
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Rochester, New York, 미국, 14618
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North Carolina
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Charlotte, North Carolina, 미국, 28210
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Greenville, North Carolina, 미국, 27834
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Hickory, North Carolina, 미국, 28602
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Ohio
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Cincinnati, Ohio, 미국, 45229
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Middleburg Heights, Ohio, 미국, 44130
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Oklahoma
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Edmond, Oklahoma, 미국, 73013
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Oklahoma City, Oklahoma, 미국, 73103
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
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Pittsburgh, Pennsylvania, 미국, 15217
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Willow Grove, Pennsylvania, 미국, 19090
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Columbia, South Carolina, 미국, 29204
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Greenville, South Carolina, 미국, 29601
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North Charleston, South Carolina, 미국, 29406
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Tennessee
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Crossville, Tennessee, 미국, 38555
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Hixon, Tennessee, 미국, 37343
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Jackson, Tennessee, 미국, 38305
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Texas
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Allen, Texas, 미국, 75013
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Dallas, Texas, 미국, 75390
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Houston, Texas, 미국, 77034
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Irving, Texas, 미국, 75061
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Mesquite, Texas, 미국, 75150
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San Antonio, Texas, 미국, 78229
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Sugar Land, Texas, 미국, 77478
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Waco, Texas, 미국, 76708
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Virginia
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Chesapeake, Virginia, 미국, 23320
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Danville, Virginia, 미국, 24541
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Richmond, Virginia, 미국, 23294
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Williamsburg, Virginia, 미국, 23185
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Washington
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Tacoma, Washington, 미국, 98405
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
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Brest, 벨라루스, 224027
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-
Grodno, 벨라루스, 230017
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Minsk, 벨라루스, 220116
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Plovdiv, 불가리아, 4002
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Sofia, 불가리아, 1612
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Stara Zagora, 불가리아, 6003
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Varna, 불가리아, 9010
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Singapore, 싱가포르, 258499
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Buenos Aires, 아르헨티나, C1417EYG
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Caba, 아르헨티나, C1181ACH
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Córdoba, 아르헨티나, X5016KEH
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Rosario, 아르헨티나, S2000PBJ
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San Juan, 아르헨티나, 5400
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Tucuman, 아르헨티나, 4000
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Graz, 오스트리아, 8036
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Vienna, 오스트리아, A1090
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Donetsk, 우크라이나, 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, 우크라이나, 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, 우크라이나, 61029
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Kryvyi Rih, 우크라이나, 50056
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Kyiv, 우크라이나, 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, 우크라이나, 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, 우크라이나, 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, 우크라이나, 95017
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Ternopil, 우크라이나, 46002
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Uzhorod, 우크라이나, 88018
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vinnytsya, 우크라이나, 21018
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zaporizhzhia, 우크라이나, 69600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zhytomyr, 우크라이나, 10002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Al Minya, 이집트, 61111
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Alexandria, 이집트, 21131
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Cairo, 이집트, 941400
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Brescia, 이탈리아, 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, 이탈리아, 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, 이탈리아, 20122
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Napoli, 이탈리아, 80131
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Padova, 이탈리아, 35128
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Palermo, 이탈리아, 90127
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Scafati, 이탈리아, 84018
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Torino, 이탈리아, 10128
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Aichi, 일본, 4600001
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Chiba, 일본, 284-0003
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Fukuoka, 일본, 807-8556
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Hokkaido, 일본, 060-8648
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Japan, 일본, 852-8501
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Miyagi, 일본, 980-8574
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Nagasaki, 일본, 856-8562
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Osaka, 일본, 530-8480
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Tokyo, 일본, 101-0062
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Osorno, 칠레, 5290000
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Santiago, 칠레, 7500000
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Valdivia, 칠레
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British Columbia
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Kelowna, British Columbia, 캐나다, V1Y3G5
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Ontario
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Markham, Ontario, 캐나다, 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, 캐나다, 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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Bogota, 콜롬비아
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bucaramanga, 콜롬비아, 681001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cali, 콜롬비아
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chia, 콜롬비아
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Medellín, 콜롬비아, 574
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, 크로아티아, 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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Bangkok, 태국, 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, 태국, 50200
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Arequipa, 페루
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, 페루, L41
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Lince, 페루, Lima14
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Piura, 페루
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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?, 폴란드, 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, 폴란드, 41-902
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Poznan, 폴란드, 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, 폴란드, 41-200
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Warsaw, 폴란드, 02-507
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Wroc?Aw, 폴란드, 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, 푸에르토 리코, 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, 푸에르토 리코, 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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Angeles City, 필리핀 제도, 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, 필리핀 제도, 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, 필리핀 제도, 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, 필리핀 제도, 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, 필리핀 제도, 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, 필리핀 제도, 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, 필리핀 제도, 1007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Paranaque, 필리핀 제도
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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, 필리핀 제도, 1102
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 위약
관리 SC
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다른 이름들:
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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실험적: LY2127399 every 2 weeks
Administered SC
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120 mg administered via subcutaneous (SC) injection for 52 weeks.
240 mg loading dose will be administered as the first dose of study drug.
다른 이름들:
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실험적: LY2127399 every 4 wks
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
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120 mg administered via subcutaneous (SC) injection for 52 weeks.
240 mg loading dose will be administered as the first dose of study drug.
다른 이름들:
52주 동안 피하 주사를 통해 투여.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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52주차에 SLE 응답자 지수 반응을 달성한 참가자의 백분율
기간: 52주
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기준선과 비교하여 SELENA SLEDAI 점수가 기준선에서 ≥ 5점 감소하고 PGA에서 악화가 없고(기준선에서 < 0.30점 증가), 새로운 BILAG A 기관 영역 점수 또는 2개의 새로운 BILAG B 기관 영역 점수가 없는 참가자의 비율 . SELENA SLEDAI는 9개의 기관 시스템에 걸쳐 24개의 개별 설명자로 계산됩니다. 0은 비활성 질병을 나타내고 최대 이론적 점수는 105입니다. 점수 > 20은 드뭅니다. PGA는 0에서 3까지의 시각적 아날로그 척도입니다(0=없음, 1=가벼움, 2=보통, 3=심함). BILAG는 9개의 기관 도메인 각각에 대해 단일 점수를 사용합니다. 범위는 중증(A)에서 질병 없음(E)까지입니다. 허용된 병용 약물 요구 사항을 준수할 수 없는 참가자는 52주 데이터가 누락되었거나 탈락한 참가자와 마찬가지로 비반응자로 간주되었습니다. |
52주
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52
기간: 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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항이중가닥데옥시리보핵산(항dsDNA) 수준의 기준선에서 52주까지의 변화
기간: 기준선, 52주
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Anti-double stranded deoxyribonucleic acid (anti-dsDNA)는 SLE 진단을 지원하는 데 사용되는 실험실 분석 물질입니다.
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기준선, 52주
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전신성 홍반성 루푸스 질환 활동 지수(SLEDAI2K) 점수의 기준선에서 52주 종료점으로 변경
기간: 기준선, 52주
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SLE 질병 활동 지수 2000(SLEDAI-2K) 점수는 루푸스 질병 활동의 가중 누적 지수입니다.
SLEDAI-2K는 9개의 장기 시스템에 걸쳐 24개의 개별 설명자에서 계산됩니다. 0은 비활성 질병을 나타내고 최대 이론적 점수는 105입니다.
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기준선, 52주
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SFI(처음 심각한 SLE 발적까지의 시간)
기간: 기준선부터 52주까지
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SFI는 SELENA-SLEDAI 질병 활동 지수 점수, 질병 활동 시나리오, 치료 변경 및 PGA를 사용하여 경증/중등도 및 중증 발적을 정의합니다. 이 지수는 총점의 절대적인 변화, 새로운 증상 또는 악화되는 증상, 질병 활동으로 인한 코르티코스테로이드 사용 또는 입원의 증가를 고려합니다. 첫 번째 중증 SLE 발적(SFI)까지의 시간(일)은 다음과 같이 계산됩니다. (첫 번째 중증 SLE 발적(SFI) 시작일 - 무작위화 날짜 + 1). |
기준선부터 52주까지
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Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks
기간: 52 weeks
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Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100 millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity.
Scores are presented from 0 to 100.
No worsening is defined as increase of ≥0.3 points.
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52 weeks
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간략한 피로 인벤토리(BFI) 점수에서 기준선에서 52주 종료점으로 변경
기간: 기준선, 52주
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지난 24시간 동안 경험한 최악의 피로를 기준으로 피로의 심각성을 측정하는 참가자 보고 척도.
심각도 점수의 범위는 0(피로 없음)에서 10(상상할 수 있는 만큼 심각한 피로)입니다.
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기준선, 52주
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Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores
기간: Baseline, 52 weeks
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The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never).
A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.
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Baseline, 52 weeks
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BILAG A(New British Isles Lupus Assessment Group) 또는 2개의 새로운 BILAG B SLE 플레어에 대한 시간
기간: 기준선부터 52주까지
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BILAG(British Isles Lupus Assessment Group) 기기는 9개의 장기 시스템 영역에 걸쳐 전 세계 질병 활동을 평가합니다. BILAG 플레어는 BILAG2004 인덱스 플레어 규칙을 사용하여 9개 장기 영역 각각에 대해 평가됩니다. A는 심각한 플레어이고 B는 중간 플레어입니다. 첫 번째 BILAG A 또는 두 개의 BILAG B 플레어까지의 시간(일)은 다음과 같이 계산됩니다. (첫 번째 BILAG A 또는 두 개의 BILAG B 플레어 시작 날짜 - 무작위화 날짜 + 1). 두 BILAG B 발적은 동일한 방문에서 서로 다른 영역에서 발생해야 합니다. |
기준선부터 52주까지
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Change From Baseline to 52 Week Endpoint in PGA
기간: Baseline, 52 weeks
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Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100-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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52주차에 코르티코스테로이드 용량이 증가한 참가자 비율
기간: 52주
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방문 시 코르티코스테로이드의 증가는 이전 예정된 방문 이후에 복용한 코르티코스테로이드의 평균 일일 용량을 사용하여 기준선에서 용량 또는 프레드니손 또는 등가물이 2.5mg/일보다 큰 변화로 정의되었습니다.
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52주
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SELENA-SLEDAI 질병 활동 점수의 기준선에서 52주 종점으로 변경
기간: 기준선, 52주
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루푸스 홍반성 루푸스 국가 평가에서 에스트로겐의 안전성 - SLE 질병 활동 지수(SELENA-SLEDAI) 점수는 루푸스 질병 활동의 가중 누적 지수입니다.
SELENA-SLEDAI는 9개의 장기 시스템에 걸쳐 24개의 개별 설명자에서 계산됩니다. 0은 비활성 질병을 나타내고 최대 이론적 점수는 105입니다.
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기준선, 52주
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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
기간: 52 weeks
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Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score) SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Patients who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data. |
52 weeks
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Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline
기간: Baseline through 52 weeks
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The BILAG2004 index is a validated global disease activity index designed on the basis of the physician's ITT, focusing on changes in disease manifestations (new, improved, worsening, etc) occurring in the last 4 weeks compared with the previous 4 weeks. The instrument assesses 97 clinical signs, symptoms, and laboratory parameters across 9 organ system domains: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, opthalmic, renal and hematology. |
Baseline through 52 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 12월 1일
기본 완료 (실제)
2014년 7월 1일
연구 완료 (실제)
2015년 6월 1일
연구 등록 날짜
최초 제출
2010년 9월 3일
QC 기준을 충족하는 최초 제출
2010년 9월 3일
처음 게시됨 (추정)
2010년 9월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 6월 11일
마지막으로 확인됨
2018년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 13656
- H9B-MC -BCDS (기타 식별자: Eli Lilly and Company)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .