A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)
31. mai 2018 oppdatert av: 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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
839
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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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Brussels, Belgia, 1090
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Bruxelles, Belgia, 1200
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Liège, Belgia, 4000
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Rio de Janeiro, Brasil, 21941-913
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Salvador, Brasil, 40050-410
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São Paulo, Brasil, 04032-060
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Mato Grosso
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Cuiaba, Mato Grosso, Brasil, 78005-000
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Minas Gerais
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Juiz de Fora, Minas Gerais, Brasil, 36038-330
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Paraná
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Curitiba, Paraná, Brasil, 80440-080
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasil, 90035-903
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Porto Alegre, Rio Grande Do Sul, Brasil, 90110-270
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Plovdiv, Bulgaria, 4002
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Ruse, Bulgaria, 7002
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Sofia, Bulgaria, 1784
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Santiago, Chile, 7500000
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Viña del Mar, Chile, 2570017
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Región Metro De Santiago
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Santiago, Región Metro De Santiago, Chile, 7501126
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Barranquilla, Colombia
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Bogota, Colombia
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Bucaramanga, Colombia
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Medellin, Colombia
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Koebenhavn, Danmark, 2100
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Odense C, Danmark, 5000
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Moscow, Den russiske føderasjonen, 115522
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Saint-Petersburg, Den russiske føderasjonen, 190068
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Yaroslavl, Den russiske føderasjonen, 150030
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Cebu City, Filippinene, 6000
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Davao City, Filippinene, 8000
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Iloilo City, Filippinene, 5000
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Las Pinas, Filippinene, 1740
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Manila, Filippinene, 1000
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Manila, Filippinene, 1015
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Quezon City, Filippinene, 1102
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Quezon City, Filippinene, 1118
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Alabama
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Birmingham, Alabama, Forente stater, 35294
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Arizona
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Peoria, Arizona, Forente stater, 85381
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Tucson, Arizona, Forente stater, 85712
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Tucson, Arizona, Forente stater, 85724
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Arkansas
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Jonesboro, Arkansas, Forente stater, 72401
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California
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La Jolla, California, Forente stater, 92037-0943
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Long Beach, California, Forente stater, 90806
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Los Angeles, California, Forente stater, 90033
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San Diego, California, Forente stater, 92120
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San Francisco, California, Forente stater, 94118
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San Jose, California, Forente stater, 95126-1650
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San Leandro, California, Forente stater, 94578
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Tustin, California, Forente stater, 92780
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Upland, California, Forente stater, 91786
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Connecticut
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Bridgeport, Connecticut, Forente stater, 06606
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Florida
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Aventura, Florida, Forente stater, 33180
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Boca Raton, Florida, Forente stater, 33486
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Boca Raton, Florida, Forente stater, 33432
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Coral Gables, Florida, Forente stater, 33134
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Fort Lauderdale, Florida, Forente stater, 33334
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Miami, Florida, Forente stater, 33136
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Orlando, Florida, Forente stater, 32804
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Orlando, Florida, Forente stater, 32806-6264
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Plantation, Florida, Forente stater, 33324
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Tampa, Florida, Forente stater, 33614
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Georgia
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Atlanta, Georgia, Forente stater, 30342
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Atlanta, Georgia, Forente stater, 30303
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Duluth, Georgia, Forente stater, 30096
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Lawrenceville, Georgia, Forente stater, 30045
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Marietta, Georgia, Forente stater, 30060
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Idaho
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Boise, Idaho, Forente stater, 83704
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Illinois
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Springfield, Illinois, Forente stater, 62704
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70809
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New Orleans, Louisiana, Forente stater, 70121
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Maryland
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Baltimore, Maryland, Forente stater, 21205
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Cumberland, Maryland, Forente stater, 21502
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Hagerstown, Maryland, Forente stater, 21740
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
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Boston, Massachusetts, Forente stater, 02115
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Michigan
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Detroit, Michigan, Forente stater, 48202
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Saint Clair Shores, Michigan, Forente stater, 48081
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Mississippi
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Jackson, Mississippi, Forente stater, 39202
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Missouri
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Saint Louis, Missouri, Forente stater, 63110
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New Mexico
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Las Cruces, New Mexico, Forente stater, 88011
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New York
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Brooklyn, New York, Forente stater, 11203
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Lake Success, New York, Forente stater, 11042
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Manhasset, New York, Forente stater, 11030
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New York, New York, Forente stater, 10016
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Smithtown, New York, Forente stater, 11787
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599-7280
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Charlotte, North Carolina, Forente stater, 28207
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Charlotte, North Carolina, Forente stater, 28210
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Durham, North Carolina, Forente stater, 27710
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Greenville, North Carolina, Forente stater, 27834
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Ohio
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Cleveland, Ohio, Forente stater, 44109
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Columbus, Ohio, Forente stater, 43203
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Dayton, Ohio, Forente stater, 45417
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Toledo, Ohio, Forente stater, 43614
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73103
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Tulsa, Oklahoma, Forente stater, 74104
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Pennsylvania
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Bethlehem, Pennsylvania, Forente stater, 18015
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Duncansville, Pennsylvania, Forente stater, 16635
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Wyomissing, Pennsylvania, Forente stater, 19610
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
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Charleston, South Carolina, Forente stater, 29406
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Greenville, South Carolina, Forente stater, 29601
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Orangeburg, South Carolina, Forente stater, 29118
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Tennessee
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Jackson, Tennessee, Forente stater, 38305
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Memphis, Tennessee, Forente stater, 38119
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Texas
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Allentown, Texas, Forente stater, 75013
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Austin, Texas, Forente stater, 78705
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Austin, Texas, Forente stater, 78758
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Dallas, Texas, Forente stater, 75231
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Houston, Texas, Forente stater, 77074
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Houston, Texas, Forente stater, 77004
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Houston, Texas, Forente stater, 77008
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Houston, Texas, Forente stater, 77034
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Nassau Bay, Texas, Forente stater, 77058
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Virginia
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Arlington, Virginia, Forente stater, 22205-3606
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Washington
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Seattle, Washington, Forente stater, 98133
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
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Wyoming
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Pennsylvania, Wyoming, Forente stater, 19610
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Paris, Frankrike, 75679
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Paris cedex 13, Frankrike, 75651
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Pessac Cedex, Frankrike, 33604
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Strasbourg cedex, Frankrike, 67091
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Suresnes, Frankrike, 92150
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Vandoeuvre les Nancy, Frankrike, 54511
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Genova, Italia, 16132
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Toscana
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Pisa, Toscana, Italia, 56126
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Veneto
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Padova, Veneto, Italia, 35128
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Fukuoka, Japan, 807-8555
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Fukuoka, Japan, 810-8563
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Hokkaido, Japan, 060-8648
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Hokkaido, Japan, 060-8604
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Miyagi, Japan, 980-8574
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Nagasaki, Japan, 857-1195
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Okinawa, Japan, 901-0243
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Shizuoka, Japan, 430-8558
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Tokyo, Japan, 160-8582
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Tokyo, Japan, 162-8655
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Tokyo, Japan, 104-8560
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Osijek, Kroatia, 31000
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Rijeka, Kroatia, 51000
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Zagreb, Kroatia, 10000
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Kuala Lumpur, Malaysia, 59100
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Seremban, Negeri Sembilan, Malaysia, 70300
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Mexico, Mexico, 06700
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Mexico, Mexico, 3100
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San Luis Potosi, Mexico, 78240
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Jalisco
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Guadalajara, Jalisco, Mexico, 44158
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Guadalajara, Jalisco, Mexico, 44690
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Morelos
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Cuernavaca, Morelos, Mexico, 62270
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Yucatán
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Merida, Yucatán, Mexico, 97130
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Bydgoszcz, Polen, 85-168
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Katowice, Polen, 40-635
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Krakow, Polen, 31-066
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Wroclaw, Polen, 50-556
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Almada, Portugal, 2801-915
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Amadora, Portugal, 2720-276
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Coimbra, Portugal, 3000-075
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Lisboa, Portugal, 1649-035
- GSK Investigational Site
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Porto, Portugal, 4099-001
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Bucharest, Romania, 020125
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Bucharest, Romania, 11172
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Bucuresti, Romania, 020475
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Belgrade, Serbia, 11000
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Belgrade, Serbia, 11080
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Singapore, Singapore, 529889
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Barcelona, Spania, 08036
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Barcelona, Spania, 8035
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Granada, Spania, 18012
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Birmingham, Storbritannia, B15 2TH
- GSK Investigational Site
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London, Storbritannia, SE1 7EH
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Warwickshire
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Coventry, Warwickshire, Storbritannia, CV2 2DX
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Göteborg, Sverige, SE-413 45
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Lund, Sverige, SE-221 85
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Stockholm, Sverige, SE-171 76
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Gueishan Township,Taoyuan County, Taiwan, 333
- GSK Investigational Site
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Kaohsiung, Taiwan, 833
- GSK Investigational Site
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Kaohsiung, Taiwan, 813
- GSK Investigational Site
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Kaohsiung, Taiwan, 807
- GSK Investigational Site
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Taichung, Taiwan, 404
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Taipei, Taiwan, 100
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Bangkok, Thailand, 10400
- GSK Investigational Site
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Bangkok, Thailand, 10700
- GSK Investigational Site
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Chiangmai, Thailand, 50200
- GSK Investigational Site
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Rajathevee, Thailand, 10400
- GSK Investigational Site
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Ratchatewi, Thailand, 10400
- GSK Investigational Site
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Songkla, Thailand, 90110
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Praha 2, Tsjekkia, 128 50
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Zlin, Tsjekkia, 760 01
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Frankfurt, Tyskland, 60590
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Hamburg, Tyskland, 22081
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Bayern
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Wuerzburg, Bayern, Tyskland, 97080
- GSK Investigational Site
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Hessen
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Bad Nauheim, Hessen, Tyskland, 61231
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Niedersachsen
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Hannover, Niedersachsen, Tyskland, 30625
- GSK Investigational Site
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Nordrhein-Westfalen
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Duesseldorf, Nordrhein-Westfalen, Tyskland, 40225
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Tyskland, 55131
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Kharkiv, Ukraina, 61039
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Kyiv, Ukraina, 01601
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Odesa, Ukraina, 65026
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Poltava, Ukraina, 36011
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Vinnytsia, Ukraina, 21018
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Zaporizhzhia, Ukraina, 69600
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Debrecen, Ungarn, 4032
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Zalaegerszeg, Ungarn, 8900
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Vienna, Østerrike, A-1100
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: 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
Standardterapi omfatter en av følgende (alene eller i kombinasjon): kortikosteroider, antimalariamidler, ikke-steroide antiinflammatoriske legemidler (NSAIDs) og immunsuppressiva; Biologiske midler og intravenøs cyklofosfamid er ikke tillatt.
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Eksperimentell: 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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Standardterapi omfatter en av følgende (alene eller i kombinasjon): kortikosteroider, antimalariamidler, ikke-steroide antiinflammatoriske legemidler (NSAIDs) og immunsuppressiva; Biologiske midler og intravenøs cyklofosfamid er ikke tillatt.
Belimumab 200 mg SC
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
16. november 2011
Primær fullføring (Faktiske)
13. februar 2015
Studiet fullført (Faktiske)
1. oktober 2015
Datoer for studieregistrering
Først innsendt
28. november 2011
Først innsendt som oppfylte QC-kriteriene
30. november 2011
Først lagt ut (Anslag)
2. desember 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juni 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mai 2018
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 112341
- 2011-003814-18
- HGS1006-C1115
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
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Skjema for informert samtykke
Informasjonsidentifikator: 112341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasettspesifikasjon
Informasjonsidentifikator: 112341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informasjonsidentifikator: 112341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasett for individuell deltaker
Informasjonsidentifikator: 112341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informasjonsidentifikator: 112341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annotert saksrapportskjema
Informasjonsidentifikator: 112341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informasjonsidentifikator: 112341Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .