A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)
2018년 5월 31일 업데이트: Human Genome Sciences Inc., a GSK Company
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).
연구 개요
상세 설명
This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE).
Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo.
Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.
연구 유형
중재적
등록 (실제)
839
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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Gueishan Township,Taoyuan County, 대만, 333
- GSK Investigational Site
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Kaohsiung, 대만, 833
- GSK Investigational Site
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Kaohsiung, 대만, 813
- GSK Investigational Site
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Kaohsiung, 대만, 807
- GSK Investigational Site
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Taichung, 대만, 404
- GSK Investigational Site
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Taipei, 대만, 100
- GSK Investigational Site
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Koebenhavn, 덴마크, 2100
- GSK Investigational Site
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Odense C, 덴마크, 5000
- GSK Investigational Site
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Frankfurt, 독일, 60590
- GSK Investigational Site
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Hamburg, 독일, 22081
- GSK Investigational Site
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Bayern
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Wuerzburg, Bayern, 독일, 97080
- GSK Investigational Site
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Hessen
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Bad Nauheim, Hessen, 독일, 61231
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, 독일, 30625
- GSK Investigational Site
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Nordrhein-Westfalen
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Duesseldorf, Nordrhein-Westfalen, 독일, 40225
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, 독일, 55131
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Moscow, 러시아 연방, 115522
- GSK Investigational Site
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Saint-Petersburg, 러시아 연방, 190068
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Yaroslavl, 러시아 연방, 150030
- GSK Investigational Site
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Bucharest, 루마니아, 020125
- GSK Investigational Site
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Bucharest, 루마니아, 11172
- GSK Investigational Site
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Bucuresti, 루마니아, 020475
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Kuala Lumpur, 말레이시아, 59100
- GSK Investigational Site
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Seremban, Negeri Sembilan, 말레이시아, 70300
- GSK Investigational Site
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Mexico, 멕시코, 06700
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Mexico, 멕시코, 3100
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San Luis Potosi, 멕시코, 78240
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Jalisco
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Guadalajara, Jalisco, 멕시코, 44158
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Guadalajara, Jalisco, 멕시코, 44690
- GSK Investigational Site
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Morelos
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Cuernavaca, Morelos, 멕시코, 62270
- GSK Investigational Site
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Yucatán
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Merida, Yucatán, 멕시코, 97130
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, 미국, 35294
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Arizona
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Peoria, Arizona, 미국, 85381
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Tucson, Arizona, 미국, 85712
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Tucson, Arizona, 미국, 85724
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Arkansas
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Jonesboro, Arkansas, 미국, 72401
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California
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La Jolla, California, 미국, 92037-0943
- GSK Investigational Site
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Long Beach, California, 미국, 90806
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Los Angeles, California, 미국, 90033
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San Diego, California, 미국, 92120
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San Francisco, California, 미국, 94118
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San Jose, California, 미국, 95126-1650
- GSK Investigational Site
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San Leandro, California, 미국, 94578
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Tustin, California, 미국, 92780
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Upland, California, 미국, 91786
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Connecticut
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Bridgeport, Connecticut, 미국, 06606
- GSK Investigational Site
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Florida
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Aventura, Florida, 미국, 33180
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Boca Raton, Florida, 미국, 33486
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Boca Raton, Florida, 미국, 33432
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Coral Gables, Florida, 미국, 33134
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Fort Lauderdale, Florida, 미국, 33334
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Miami, Florida, 미국, 33136
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Orlando, Florida, 미국, 32804
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Orlando, Florida, 미국, 32806-6264
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Plantation, Florida, 미국, 33324
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Tampa, Florida, 미국, 33614
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Georgia
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Atlanta, Georgia, 미국, 30342
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Atlanta, Georgia, 미국, 30303
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Duluth, Georgia, 미국, 30096
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Lawrenceville, Georgia, 미국, 30045
- GSK Investigational Site
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Marietta, Georgia, 미국, 30060
- GSK Investigational Site
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Idaho
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Boise, Idaho, 미국, 83704
- GSK Investigational Site
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Illinois
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Springfield, Illinois, 미국, 62704
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Louisiana
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Baton Rouge, Louisiana, 미국, 70809
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New Orleans, Louisiana, 미국, 70121
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Maryland
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Baltimore, Maryland, 미국, 21205
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Cumberland, Maryland, 미국, 21502
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Hagerstown, Maryland, 미국, 21740
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Massachusetts
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Boston, Massachusetts, 미국, 02118
- GSK Investigational Site
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Boston, Massachusetts, 미국, 02115
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Michigan
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Detroit, Michigan, 미국, 48202
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Saint Clair Shores, Michigan, 미국, 48081
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Mississippi
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Jackson, Mississippi, 미국, 39202
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Missouri
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Saint Louis, Missouri, 미국, 63110
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New Mexico
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Las Cruces, New Mexico, 미국, 88011
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New York
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Brooklyn, New York, 미국, 11203
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Lake Success, New York, 미국, 11042
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Manhasset, New York, 미국, 11030
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New York, New York, 미국, 10016
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Smithtown, New York, 미국, 11787
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7280
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Charlotte, North Carolina, 미국, 28207
- GSK Investigational Site
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Charlotte, North Carolina, 미국, 28210
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Durham, North Carolina, 미국, 27710
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Greenville, North Carolina, 미국, 27834
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, 미국, 44109
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Columbus, Ohio, 미국, 43203
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Dayton, Ohio, 미국, 45417
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Toledo, Ohio, 미국, 43614
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73103
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Tulsa, Oklahoma, 미국, 74104
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Pennsylvania
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Bethlehem, Pennsylvania, 미국, 18015
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Duncansville, Pennsylvania, 미국, 16635
- GSK Investigational Site
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Wyomissing, Pennsylvania, 미국, 19610
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South Carolina
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Charleston, South Carolina, 미국, 29425
- GSK Investigational Site
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Charleston, South Carolina, 미국, 29406
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Greenville, South Carolina, 미국, 29601
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Orangeburg, South Carolina, 미국, 29118
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Tennessee
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Jackson, Tennessee, 미국, 38305
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Memphis, Tennessee, 미국, 38119
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Texas
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Allentown, Texas, 미국, 75013
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Austin, Texas, 미국, 78705
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Austin, Texas, 미국, 78758
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Dallas, Texas, 미국, 75231
- GSK Investigational Site
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Houston, Texas, 미국, 77074
- GSK Investigational Site
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Houston, Texas, 미국, 77004
- GSK Investigational Site
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Houston, Texas, 미국, 77008
- GSK Investigational Site
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Houston, Texas, 미국, 77034
- GSK Investigational Site
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Nassau Bay, Texas, 미국, 77058
- GSK Investigational Site
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Virginia
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Arlington, Virginia, 미국, 22205-3606
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Washington
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Seattle, Washington, 미국, 98133
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
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Wyoming
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Pennsylvania, Wyoming, 미국, 19610
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Brussels, 벨기에, 1090
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Bruxelles, 벨기에, 1200
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Liège, 벨기에, 4000
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Plovdiv, 불가리아, 4002
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Ruse, 불가리아, 7002
- GSK Investigational Site
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Sofia, 불가리아, 1784
- GSK Investigational Site
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Rio de Janeiro, 브라질, 21941-913
- GSK Investigational Site
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Salvador, 브라질, 40050-410
- GSK Investigational Site
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São Paulo, 브라질, 04032-060
- GSK Investigational Site
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Mato Grosso
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Cuiaba, Mato Grosso, 브라질, 78005-000
- GSK Investigational Site
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Minas Gerais
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Juiz de Fora, Minas Gerais, 브라질, 36038-330
- GSK Investigational Site
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Paraná
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Curitiba, Paraná, 브라질, 80440-080
- GSK Investigational Site
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, 브라질, 90035-903
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, 브라질, 90110-270
- GSK Investigational Site
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Belgrade, 세르비아, 11000
- GSK Investigational Site
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Belgrade, 세르비아, 11080
- GSK Investigational Site
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Göteborg, 스웨덴, SE-413 45
- GSK Investigational Site
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Lund, 스웨덴, SE-221 85
- GSK Investigational Site
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Stockholm, 스웨덴, SE-171 76
- GSK Investigational Site
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Barcelona, 스페인, 08036
- GSK Investigational Site
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Barcelona, 스페인, 8035
- GSK Investigational Site
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Granada, 스페인, 18012
- GSK Investigational Site
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Singapore, 싱가포르, 529889
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Ciudad Autonoma Buenos Aires, 아르헨티나, C1015ABO
- GSK Investigational Site
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Ciudad Autonoma Buenos Aires, 아르헨티나, C1426AAL
- GSK Investigational Site
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, 아르헨티나, C1419AHN
- GSK Investigational Site
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Ciudad Autonoma de Buenos Aires, Buenos Aires, 아르헨티나, C1181ACI
- GSK Investigational Site
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La Plata, Buenos Aires, 아르헨티나, B1902COS
- GSK Investigational Site
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Birmingham, 영국, B15 2TH
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London, 영국, SE1 7EH
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Warwickshire
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Coventry, Warwickshire, 영국, CV2 2DX
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Vienna, 오스트리아, A-1100
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Kharkiv, 우크라이나, 61039
- GSK Investigational Site
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Kyiv, 우크라이나, 01601
- GSK Investigational Site
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Odesa, 우크라이나, 65026
- GSK Investigational Site
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Poltava, 우크라이나, 36011
- GSK Investigational Site
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Vinnytsia, 우크라이나, 21018
- GSK Investigational Site
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Zaporizhzhia, 우크라이나, 69600
- GSK Investigational Site
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Genova, 이탈리아, 16132
- GSK Investigational Site
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Toscana
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Pisa, Toscana, 이탈리아, 56126
- GSK Investigational Site
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Veneto
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Padova, Veneto, 이탈리아, 35128
- GSK Investigational Site
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Fukuoka, 일본, 807-8555
- GSK Investigational Site
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Fukuoka, 일본, 810-8563
- GSK Investigational Site
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Hokkaido, 일본, 060-8648
- GSK Investigational Site
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Hokkaido, 일본, 060-8604
- GSK Investigational Site
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Miyagi, 일본, 980-8574
- GSK Investigational Site
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Nagasaki, 일본, 857-1195
- GSK Investigational Site
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Okinawa, 일본, 901-0243
- GSK Investigational Site
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Shizuoka, 일본, 430-8558
- GSK Investigational Site
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Tokyo, 일본, 160-8582
- GSK Investigational Site
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Tokyo, 일본, 162-8655
- GSK Investigational Site
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Tokyo, 일본, 104-8560
- GSK Investigational Site
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Praha 2, 체코, 128 50
- GSK Investigational Site
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Zlin, 체코, 760 01
- GSK Investigational Site
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Santiago, 칠레, 7500000
- GSK Investigational Site
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Viña del Mar, 칠레, 2570017
- GSK Investigational Site
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Región Metro De Santiago
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Santiago, Región Metro De Santiago, 칠레, 7501126
- GSK Investigational Site
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Barranquilla, 콜롬비아
- GSK Investigational Site
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Bogota, 콜롬비아
- GSK Investigational Site
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Bucaramanga, 콜롬비아
- GSK Investigational Site
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Medellin, 콜롬비아
- GSK Investigational Site
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Osijek, 크로아티아, 31000
- GSK Investigational Site
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Rijeka, 크로아티아, 51000
- GSK Investigational Site
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Zagreb, 크로아티아, 10000
- GSK Investigational Site
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Bangkok, 태국, 10400
- GSK Investigational Site
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Bangkok, 태국, 10700
- GSK Investigational Site
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Chiangmai, 태국, 50200
- GSK Investigational Site
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Rajathevee, 태국, 10400
- GSK Investigational Site
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Ratchatewi, 태국, 10400
- GSK Investigational Site
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Songkla, 태국, 90110
- GSK Investigational Site
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Almada, 포르투갈, 2801-915
- GSK Investigational Site
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Amadora, 포르투갈, 2720-276
- GSK Investigational Site
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Coimbra, 포르투갈, 3000-075
- GSK Investigational Site
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Lisboa, 포르투갈, 1649-035
- GSK Investigational Site
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Porto, 포르투갈, 4099-001
- GSK Investigational Site
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Bydgoszcz, 폴란드, 85-168
- GSK Investigational Site
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Katowice, 폴란드, 40-635
- GSK Investigational Site
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Krakow, 폴란드, 31-066
- GSK Investigational Site
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Wroclaw, 폴란드, 50-556
- GSK Investigational Site
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Paris, 프랑스, 75679
- GSK Investigational Site
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Paris cedex 13, 프랑스, 75651
- GSK Investigational Site
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Pessac Cedex, 프랑스, 33604
- GSK Investigational Site
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Strasbourg cedex, 프랑스, 67091
- GSK Investigational Site
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Suresnes, 프랑스, 92150
- GSK Investigational Site
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Vandoeuvre les Nancy, 프랑스, 54511
- GSK Investigational Site
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Cebu City, 필리핀 제도, 6000
- GSK Investigational Site
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Davao City, 필리핀 제도, 8000
- GSK Investigational Site
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Iloilo City, 필리핀 제도, 5000
- GSK Investigational Site
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Las Pinas, 필리핀 제도, 1740
- GSK Investigational Site
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Manila, 필리핀 제도, 1000
- GSK Investigational Site
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Manila, 필리핀 제도, 1015
- GSK Investigational Site
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Quezon City, 필리핀 제도, 1102
- GSK Investigational Site
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Quezon City, 필리핀 제도, 1118
- GSK Investigational Site
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Debrecen, 헝가리, 4032
- GSK Investigational Site
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Zalaegerszeg, 헝가리, 8900
- GSK Investigational Site
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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:
- At least 18 years of age.
- Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)
Exclusion Criteria:
- Pregnant or nursing.
- Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
- Have received treatment an investigational biological agent in the past year.
- Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
- Have severe active lupus kidney disease.
- Have severe active central nervous system (CNS) lupus.
- Have required management of acute or chronic infections within the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Have a history of hypersensitivity reactions to contrast agents or biological medicines.
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Placebo plus standard therapy
Placebo SC plus standard therapy; placebo administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with final evaluation at Week 52 in the double-blind period.
In the open-label extension period, placebo subjects who opt to participate will receive belimumab 200 mg SC weekly for an additional 6-months.
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위약
표준 요법은 다음 중 임의의 것을 포함합니다(단독 또는 병용): 코르티코스테로이드, 항말라리아제, 비스테로이드성 항염증제(NSAID) 및 면역억제제; 생물학적 제제 및 정맥 내 시클로포스파미드는 허용되지 않습니다.
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실험적: Belimumab 200 mg SC plus standard therapy
Belimumab 200 mg SC plus standard therapy; belimumab administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with a final evaluation at Week 52 in the double-blind period.
In the open-label extension period, subjects who opt to participate will continue on the same dose of belimumab for an additional 6-months.
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표준 요법은 다음 중 임의의 것을 포함합니다(단독 또는 병용): 코르티코스테로이드, 항말라리아제, 비스테로이드성 항염증제(NSAID) 및 면역억제제; 생물학적 제제 및 정맥 내 시클로포스파미드는 허용되지 않습니다.
Belimumab 200 mg SC
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
기간: Week 52
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SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline.
Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).
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Week 52
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
기간: Baseline (Day 0, prior to dosing) to Week 52
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Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1).
Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity).
Only post-baseline severe flares were considered.
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Baseline (Day 0, prior to dosing) to Week 52
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Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline
기간: Baseline (Day 0, prior to dosing), Weeks 40 through Week 52
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For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg.
The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons.
A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52.
At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7.
For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52.
Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).
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Baseline (Day 0, prior to dosing), Weeks 40 through Week 52
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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
- Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.
- Maslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1):e000459. doi: 10.1136/lupus-2020-000459.
- Lokhandwala T, Yue B, Coutinho AD, Bell CF. Within-trial economic analysis of flare data from the BLISS-SC trial of subcutaneous belimumab in systemic lupus erythematosus. Lupus Sci Med. 2021 Feb;8(1):e000438. doi: 10.1136/lupus-2020-000438.
- Doria A, Bass D, Schwarting A, Hammer A, Gordon D, Scheinberg M, Fox NL, Groark J, Stohl W, Kleoudis C, Roth D. A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus. Lupus. 2018 Aug;27(9):1489-1498. doi: 10.1177/0961203318777634. Epub 2018 May 28.
- Doria A, Stohl W, Schwarting A, Okada M, Scheinberg M, van Vollenhoven R, Hammer AE, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Anti-Double-Stranded DNA-Positive, Hypocomplementemic Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2018 Aug;70(8):1256-1264. doi: 10.1002/art.40511. Epub 2018 Jun 15.
- Stohl W, Schwarting A, Okada M, Scheinberg M, Doria A, Hammer AE, Kleoudis C, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study. Arthritis Rheumatol. 2017 May;69(5):1016-1027. doi: 10.1002/art.40049. Epub 2017 Apr 7.
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
2011년 11월 16일
기본 완료 (실제)
2015년 2월 13일
연구 완료 (실제)
2015년 10월 1일
연구 등록 날짜
최초 제출
2011년 11월 28일
QC 기준을 충족하는 최초 제출
2011년 11월 30일
처음 게시됨 (추정)
2011년 12월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 6월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 5월 31일
마지막으로 확인됨
2018년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 112341
- 2011-003814-18
- HGS1006-C1115
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
연구 데이터/문서
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정보에 입각한 동의서
정보 식별자: 112341정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 112341정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 112341정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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개별 참가자 데이터 세트
정보 식별자: 112341정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 112341정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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주석이 달린 사례 보고서 양식
정보 식별자: 112341정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 112341정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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. .
전신성 홍반성 루푸스에 대한 임상 시험
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Union Hospital, Tongji Medical College, Huazhong...아직 모집하지 않음전신 홍반성 루푸스(Systemic Lupus Erythematosus, SLE)중국
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Istanbul Galata UniversityThe Scientific and Technological Research Council of Turkey아직 모집하지 않음전신 홍반성 루푸스(Systemic Lupus Erythematosus, SLE)터키 (Türkiye)
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Tongji Hospital아직 모집하지 않음전신 홍반성 루푸스(Systemic Lupus Erythematosus, SLE)중국
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University of California, San Francisco완전한
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Union Hospital, Tongji Medical College, Huazhong...Everest Medicines (China) Co.,Ltd.모병경피증 | 전신 홍반성 루푸스(Systemic Lupus Erythematosus, SLE) | 중증근무력증(MG)중국
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University of the West of EnglandAlder Hey Children's NHS Foundation Trust; Bristol Royal Hospital for Children; Glasgow Royal...모병
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West China Hospital알려지지 않은
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Chitwan Medical College완전한Neplaese Lupus Nephritis 환자에서 Mycophenolate Mofetil과 Cyclophosphamide의 효과 비교
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Aga Khan University알려지지 않은뇌병증, 간 | 간뇌 뇌병증 | Portal-Systemic Encephalopathy | 뇌병증, 간뇌파키스탄
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University Hospital Freiburg모병간경화 | 문맥 고혈압 | 문맥 혈전증 | 비간경변 문맥 고혈압 | 버드 키아리 증후군 | Portal Systemic Shunt독일
위약에 대한 임상 시험
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Newish Biotech (Wuxi) Co., Ltd.아직 모집하지 않음
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Chiesi Farmaceutici S.p.A.아직 모집하지 않음
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Nature's Sunshine Products, Inc.아직 모집하지 않음
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Yale UniversityHartford HealthCare아직 모집하지 않음
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Acesion Pharma모병심방세동(AF)헝가리, 폴란드, 불가리아, 덴마크, 독일, 네덜란드, 이탈리아, 세르비아
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Shanghai Lanyi Therapeutics Co., Ltd.완전한
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Vertex Pharmaceuticals Incorporated모병
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Enanta Pharmaceuticals, Inc아직 모집하지 않음호흡기 세포융합 바이러스(RSV) | RSV 감염 | RSV