A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)
31 de mayo de 2018 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
839
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Frankfurt, Alemania, 60590
- GSK Investigational Site
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Hamburg, Alemania, 22081
- GSK Investigational Site
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Bayern
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Wuerzburg, Bayern, Alemania, 97080
- GSK Investigational Site
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Hessen
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Bad Nauheim, Hessen, Alemania, 61231
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Alemania, 30625
- GSK Investigational Site
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Nordrhein-Westfalen
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Duesseldorf, Nordrhein-Westfalen, Alemania, 40225
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Alemania, 55131
- GSK Investigational Site
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Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
- GSK Investigational Site
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Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
- GSK Investigational Site
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
- GSK Investigational Site
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACI
- GSK Investigational Site
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La Plata, Buenos Aires, Argentina, B1902COS
- GSK Investigational Site
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Vienna, Austria, A-1100
- GSK Investigational Site
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Rio de Janeiro, Brasil, 21941-913
- GSK Investigational Site
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Salvador, Brasil, 40050-410
- GSK Investigational Site
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São Paulo, Brasil, 04032-060
- GSK Investigational Site
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Mato Grosso
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Cuiaba, Mato Grosso, Brasil, 78005-000
- GSK Investigational Site
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Minas Gerais
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Juiz de Fora, Minas Gerais, Brasil, 36038-330
- GSK Investigational Site
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Paraná
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Curitiba, Paraná, Brasil, 80440-080
- GSK Investigational Site
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasil, 90035-903
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, Brasil, 90110-270
- GSK Investigational Site
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Plovdiv, Bulgaria, 4002
- GSK Investigational Site
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Ruse, Bulgaria, 7002
- GSK Investigational Site
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Sofia, Bulgaria, 1784
- GSK Investigational Site
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Brussels, Bélgica, 1090
- GSK Investigational Site
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Bruxelles, Bélgica, 1200
- GSK Investigational Site
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Liège, Bélgica, 4000
- GSK Investigational Site
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Praha 2, Chequia, 128 50
- GSK Investigational Site
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Zlin, Chequia, 760 01
- GSK Investigational Site
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Santiago, Chile, 7500000
- GSK Investigational Site
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Viña del Mar, Chile, 2570017
- GSK Investigational Site
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Región Metro De Santiago
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Santiago, Región Metro De Santiago, Chile, 7501126
- GSK Investigational Site
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Barranquilla, Colombia
- GSK Investigational Site
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Bogota, Colombia
- GSK Investigational Site
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Bucaramanga, Colombia
- GSK Investigational Site
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Medellin, Colombia
- GSK Investigational Site
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Osijek, Croacia, 31000
- GSK Investigational Site
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Rijeka, Croacia, 51000
- GSK Investigational Site
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Zagreb, Croacia, 10000
- GSK Investigational Site
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Koebenhavn, Dinamarca, 2100
- GSK Investigational Site
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Odense C, Dinamarca, 5000
- GSK Investigational Site
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Barcelona, España, 08036
- GSK Investigational Site
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Barcelona, España, 8035
- GSK Investigational Site
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Granada, España, 18012
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- GSK Investigational Site
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Arizona
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Peoria, Arizona, Estados Unidos, 85381
- GSK Investigational Site
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Tucson, Arizona, Estados Unidos, 85712
- GSK Investigational Site
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Tucson, Arizona, Estados Unidos, 85724
- GSK Investigational Site
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Arkansas
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Jonesboro, Arkansas, Estados Unidos, 72401
- GSK Investigational Site
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California
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La Jolla, California, Estados Unidos, 92037-0943
- GSK Investigational Site
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Long Beach, California, Estados Unidos, 90806
- GSK Investigational Site
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Los Angeles, California, Estados Unidos, 90033
- GSK Investigational Site
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San Diego, California, Estados Unidos, 92120
- GSK Investigational Site
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San Francisco, California, Estados Unidos, 94118
- GSK Investigational Site
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San Jose, California, Estados Unidos, 95126-1650
- GSK Investigational Site
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San Leandro, California, Estados Unidos, 94578
- GSK Investigational Site
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Tustin, California, Estados Unidos, 92780
- GSK Investigational Site
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Upland, California, Estados Unidos, 91786
- GSK Investigational Site
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Connecticut
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Bridgeport, Connecticut, Estados Unidos, 06606
- GSK Investigational Site
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Florida
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Aventura, Florida, Estados Unidos, 33180
- GSK Investigational Site
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Boca Raton, Florida, Estados Unidos, 33486
- GSK Investigational Site
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Boca Raton, Florida, Estados Unidos, 33432
- GSK Investigational Site
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Coral Gables, Florida, Estados Unidos, 33134
- GSK Investigational Site
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Fort Lauderdale, Florida, Estados Unidos, 33334
- GSK Investigational Site
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Miami, Florida, Estados Unidos, 33136
- GSK Investigational Site
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Orlando, Florida, Estados Unidos, 32804
- GSK Investigational Site
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Orlando, Florida, Estados Unidos, 32806-6264
- GSK Investigational Site
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Plantation, Florida, Estados Unidos, 33324
- GSK Investigational Site
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Tampa, Florida, Estados Unidos, 33614
- GSK Investigational Site
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- GSK Investigational Site
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Atlanta, Georgia, Estados Unidos, 30303
- GSK Investigational Site
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Duluth, Georgia, Estados Unidos, 30096
- GSK Investigational Site
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Lawrenceville, Georgia, Estados Unidos, 30045
- GSK Investigational Site
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Marietta, Georgia, Estados Unidos, 30060
- GSK Investigational Site
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Idaho
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Boise, Idaho, Estados Unidos, 83704
- GSK Investigational Site
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Illinois
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Springfield, Illinois, Estados Unidos, 62704
- GSK Investigational Site
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- GSK Investigational Site
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New Orleans, Louisiana, Estados Unidos, 70121
- GSK Investigational Site
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Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- GSK Investigational Site
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Cumberland, Maryland, Estados Unidos, 21502
- GSK Investigational Site
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Hagerstown, Maryland, Estados Unidos, 21740
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- GSK Investigational Site
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Boston, Massachusetts, Estados Unidos, 02115
- GSK Investigational Site
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- GSK Investigational Site
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Saint Clair Shores, Michigan, Estados Unidos, 48081
- GSK Investigational Site
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39202
- GSK Investigational Site
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- GSK Investigational Site
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New Mexico
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Las Cruces, New Mexico, Estados Unidos, 88011
- GSK Investigational Site
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New York
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Brooklyn, New York, Estados Unidos, 11203
- GSK Investigational Site
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Lake Success, New York, Estados Unidos, 11042
- GSK Investigational Site
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Manhasset, New York, Estados Unidos, 11030
- GSK Investigational Site
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New York, New York, Estados Unidos, 10016
- GSK Investigational Site
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Smithtown, New York, Estados Unidos, 11787
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7280
- GSK Investigational Site
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Charlotte, North Carolina, Estados Unidos, 28207
- GSK Investigational Site
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Charlotte, North Carolina, Estados Unidos, 28210
- GSK Investigational Site
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Durham, North Carolina, Estados Unidos, 27710
- GSK Investigational Site
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Greenville, North Carolina, Estados Unidos, 27834
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, Estados Unidos, 44109
- GSK Investigational Site
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Columbus, Ohio, Estados Unidos, 43203
- GSK Investigational Site
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Dayton, Ohio, Estados Unidos, 45417
- GSK Investigational Site
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Toledo, Ohio, Estados Unidos, 43614
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73103
- GSK Investigational Site
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Tulsa, Oklahoma, Estados Unidos, 74104
- GSK Investigational Site
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Pennsylvania
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Bethlehem, Pennsylvania, Estados Unidos, 18015
- GSK Investigational Site
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Duncansville, Pennsylvania, Estados Unidos, 16635
- GSK Investigational Site
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Wyomissing, Pennsylvania, Estados Unidos, 19610
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- GSK Investigational Site
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Charleston, South Carolina, Estados Unidos, 29406
- GSK Investigational Site
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Greenville, South Carolina, Estados Unidos, 29601
- GSK Investigational Site
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Orangeburg, South Carolina, Estados Unidos, 29118
- GSK Investigational Site
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Tennessee
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Jackson, Tennessee, Estados Unidos, 38305
- GSK Investigational Site
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Memphis, Tennessee, Estados Unidos, 38119
- GSK Investigational Site
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Texas
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Allentown, Texas, Estados Unidos, 75013
- GSK Investigational Site
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Austin, Texas, Estados Unidos, 78705
- GSK Investigational Site
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Austin, Texas, Estados Unidos, 78758
- GSK Investigational Site
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Dallas, Texas, Estados Unidos, 75231
- GSK Investigational Site
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Houston, Texas, Estados Unidos, 77074
- GSK Investigational Site
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Houston, Texas, Estados Unidos, 77004
- GSK Investigational Site
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Houston, Texas, Estados Unidos, 77008
- GSK Investigational Site
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Houston, Texas, Estados Unidos, 77034
- GSK Investigational Site
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Nassau Bay, Texas, Estados Unidos, 77058
- GSK Investigational Site
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Virginia
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Arlington, Virginia, Estados Unidos, 22205-3606
- GSK Investigational Site
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Washington
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Seattle, Washington, Estados Unidos, 98133
- GSK Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- GSK Investigational Site
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Wyoming
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Pennsylvania, Wyoming, Estados Unidos, 19610
- GSK Investigational Site
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Moscow, Federación Rusa, 115522
- GSK Investigational Site
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Saint-Petersburg, Federación Rusa, 190068
- GSK Investigational Site
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Yaroslavl, Federación Rusa, 150030
- GSK Investigational Site
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Cebu City, Filipinas, 6000
- GSK Investigational Site
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Davao City, Filipinas, 8000
- GSK Investigational Site
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Iloilo City, Filipinas, 5000
- GSK Investigational Site
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Las Pinas, Filipinas, 1740
- GSK Investigational Site
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Manila, Filipinas, 1000
- GSK Investigational Site
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Manila, Filipinas, 1015
- GSK Investigational Site
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Quezon City, Filipinas, 1102
- GSK Investigational Site
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Quezon City, Filipinas, 1118
- GSK Investigational Site
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Paris, Francia, 75679
- GSK Investigational Site
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Paris cedex 13, Francia, 75651
- GSK Investigational Site
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Pessac Cedex, Francia, 33604
- GSK Investigational Site
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Strasbourg cedex, Francia, 67091
- GSK Investigational Site
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Suresnes, Francia, 92150
- GSK Investigational Site
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Vandoeuvre les Nancy, Francia, 54511
- GSK Investigational Site
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Debrecen, Hungría, 4032
- GSK Investigational Site
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Zalaegerszeg, Hungría, 8900
- GSK Investigational Site
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Genova, Italia, 16132
- GSK Investigational Site
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Toscana
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Pisa, Toscana, Italia, 56126
- GSK Investigational Site
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Veneto
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Padova, Veneto, Italia, 35128
- GSK Investigational Site
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Fukuoka, Japón, 807-8555
- GSK Investigational Site
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Fukuoka, Japón, 810-8563
- GSK Investigational Site
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Hokkaido, Japón, 060-8648
- GSK Investigational Site
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Hokkaido, Japón, 060-8604
- GSK Investigational Site
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Miyagi, Japón, 980-8574
- GSK Investigational Site
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Nagasaki, Japón, 857-1195
- GSK Investigational Site
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Okinawa, Japón, 901-0243
- GSK Investigational Site
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Shizuoka, Japón, 430-8558
- GSK Investigational Site
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Tokyo, Japón, 160-8582
- GSK Investigational Site
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Tokyo, Japón, 162-8655
- GSK Investigational Site
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Tokyo, Japón, 104-8560
- GSK Investigational Site
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Kuala Lumpur, Malasia, 59100
- GSK Investigational Site
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Seremban, Negeri Sembilan, Malasia, 70300
- GSK Investigational Site
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Mexico, México, 06700
- GSK Investigational Site
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Mexico, México, 3100
- GSK Investigational Site
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San Luis Potosi, México, 78240
- GSK Investigational Site
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Jalisco
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Guadalajara, Jalisco, México, 44158
- GSK Investigational Site
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Guadalajara, Jalisco, México, 44690
- GSK Investigational Site
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Morelos
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Cuernavaca, Morelos, México, 62270
- GSK Investigational Site
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Yucatán
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Merida, Yucatán, México, 97130
- GSK Investigational Site
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Bydgoszcz, Polonia, 85-168
- GSK Investigational Site
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Katowice, Polonia, 40-635
- GSK Investigational Site
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Krakow, Polonia, 31-066
- GSK Investigational Site
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Wroclaw, Polonia, 50-556
- GSK Investigational Site
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Almada, Portugal, 2801-915
- GSK Investigational Site
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Amadora, Portugal, 2720-276
- GSK Investigational Site
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Coimbra, Portugal, 3000-075
- GSK Investigational Site
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Lisboa, Portugal, 1649-035
- GSK Investigational Site
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Porto, Portugal, 4099-001
- GSK Investigational Site
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Birmingham, Reino Unido, B15 2TH
- GSK Investigational Site
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London, Reino Unido, SE1 7EH
- GSK Investigational Site
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Warwickshire
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Coventry, Warwickshire, Reino Unido, CV2 2DX
- GSK Investigational Site
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Bucharest, Rumania, 020125
- GSK Investigational Site
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Bucharest, Rumania, 11172
- GSK Investigational Site
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Bucuresti, Rumania, 020475
- GSK Investigational Site
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Belgrade, Serbia, 11000
- GSK Investigational Site
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Belgrade, Serbia, 11080
- GSK Investigational Site
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Singapore, Singapur, 529889
- GSK Investigational Site
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Göteborg, Suecia, SE-413 45
- GSK Investigational Site
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Lund, Suecia, SE-221 85
- GSK Investigational Site
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Stockholm, Suecia, SE-171 76
- GSK Investigational Site
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Bangkok, Tailandia, 10400
- GSK Investigational Site
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Bangkok, Tailandia, 10700
- GSK Investigational Site
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Chiangmai, Tailandia, 50200
- GSK Investigational Site
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Rajathevee, Tailandia, 10400
- GSK Investigational Site
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Ratchatewi, Tailandia, 10400
- GSK Investigational Site
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Songkla, Tailandia, 90110
- GSK Investigational Site
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Gueishan Township,Taoyuan County, Taiwán, 333
- GSK Investigational Site
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Kaohsiung, Taiwán, 833
- GSK Investigational Site
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Kaohsiung, Taiwán, 813
- GSK Investigational Site
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Kaohsiung, Taiwán, 807
- GSK Investigational Site
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Taichung, Taiwán, 404
- GSK Investigational Site
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Taipei, Taiwán, 100
- GSK Investigational Site
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Kharkiv, Ucrania, 61039
- GSK Investigational Site
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Kyiv, Ucrania, 01601
- GSK Investigational Site
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Odesa, Ucrania, 65026
- GSK Investigational Site
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Poltava, Ucrania, 36011
- GSK Investigational Site
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Vinnytsia, Ucrania, 21018
- GSK Investigational Site
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Zaporizhzhia, Ucrania, 69600
- GSK Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: 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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Placebo
La terapia estándar comprende cualquiera de los siguientes (solos o en combinación): corticosteroides, antipalúdicos, medicamentos antiinflamatorios no esteroideos (AINE) e inmunosupresores; No se permiten productos biológicos ni ciclofosfamida intravenosa.
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Experimental: 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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La terapia estándar comprende cualquiera de los siguientes (solos o en combinación): corticosteroides, antipalúdicos, medicamentos antiinflamatorios no esteroideos (AINE) e inmunosupresores; No se permiten productos biológicos ni ciclofosfamida intravenosa.
Belimumab 200 mg SC
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
16 de noviembre de 2011
Finalización primaria (Actual)
13 de febrero de 2015
Finalización del estudio (Actual)
1 de octubre de 2015
Fechas de registro del estudio
Enviado por primera vez
28 de noviembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
30 de noviembre de 2011
Publicado por primera vez (Estimar)
2 de diciembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
31 de mayo de 2018
Última verificación
1 de mayo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 112341
- 2011-003814-18
- HGS1006-C1115
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Datos del estudio/Documentos
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Formulario de consentimiento informado
Identificador de información: 112341Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Especificación del conjunto de datos
Identificador de información: 112341Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Informe de estudio clínico
Identificador de información: 112341Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de datos de participantes individuales
Identificador de información: 112341Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Plan de Análisis Estadístico
Identificador de información: 112341Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de informe de caso anotado
Identificador de información: 112341Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudio
Identificador de información: 112341Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .