A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)
31 maj 2018 uppdaterad 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
839
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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, Belgien, 1090
- GSK Investigational Site
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Bruxelles, Belgien, 1200
- GSK Investigational Site
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Liège, Belgien, 4000
- GSK Investigational Site
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Rio de Janeiro, Brasilien, 21941-913
- GSK Investigational Site
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Salvador, Brasilien, 40050-410
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São Paulo, Brasilien, 04032-060
- GSK Investigational Site
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Mato Grosso
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Cuiaba, Mato Grosso, Brasilien, 78005-000
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Minas Gerais
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Juiz de Fora, Minas Gerais, Brasilien, 36038-330
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Paraná
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Curitiba, Paraná, Brasilien, 80440-080
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasilien, 90035-903
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Porto Alegre, Rio Grande Do Sul, Brasilien, 90110-270
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Plovdiv, Bulgarien, 4002
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Ruse, Bulgarien, 7002
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Sofia, Bulgarien, 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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Cebu City, Filippinerna, 6000
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Davao City, Filippinerna, 8000
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Iloilo City, Filippinerna, 5000
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Las Pinas, Filippinerna, 1740
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Manila, Filippinerna, 1000
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Manila, Filippinerna, 1015
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Quezon City, Filippinerna, 1102
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Quezon City, Filippinerna, 1118
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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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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
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Arizona
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Peoria, Arizona, Förenta staterna, 85381
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Tucson, Arizona, Förenta staterna, 85712
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Tucson, Arizona, Förenta staterna, 85724
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Arkansas
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Jonesboro, Arkansas, Förenta staterna, 72401
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California
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La Jolla, California, Förenta staterna, 92037-0943
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Long Beach, California, Förenta staterna, 90806
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Los Angeles, California, Förenta staterna, 90033
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San Diego, California, Förenta staterna, 92120
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San Francisco, California, Förenta staterna, 94118
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San Jose, California, Förenta staterna, 95126-1650
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San Leandro, California, Förenta staterna, 94578
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Tustin, California, Förenta staterna, 92780
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Upland, California, Förenta staterna, 91786
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Connecticut
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Bridgeport, Connecticut, Förenta staterna, 06606
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Florida
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Aventura, Florida, Förenta staterna, 33180
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Boca Raton, Florida, Förenta staterna, 33486
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Boca Raton, Florida, Förenta staterna, 33432
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Coral Gables, Florida, Förenta staterna, 33134
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Fort Lauderdale, Florida, Förenta staterna, 33334
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Miami, Florida, Förenta staterna, 33136
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Orlando, Florida, Förenta staterna, 32804
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Orlando, Florida, Förenta staterna, 32806-6264
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Plantation, Florida, Förenta staterna, 33324
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Tampa, Florida, Förenta staterna, 33614
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Georgia
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Atlanta, Georgia, Förenta staterna, 30342
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Atlanta, Georgia, Förenta staterna, 30303
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Duluth, Georgia, Förenta staterna, 30096
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Lawrenceville, Georgia, Förenta staterna, 30045
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Marietta, Georgia, Förenta staterna, 30060
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Idaho
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Boise, Idaho, Förenta staterna, 83704
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Illinois
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Springfield, Illinois, Förenta staterna, 62704
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70809
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New Orleans, Louisiana, Förenta staterna, 70121
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Maryland
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Baltimore, Maryland, Förenta staterna, 21205
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Cumberland, Maryland, Förenta staterna, 21502
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Hagerstown, Maryland, Förenta staterna, 21740
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02118
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Boston, Massachusetts, Förenta staterna, 02115
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Michigan
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Detroit, Michigan, Förenta staterna, 48202
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Saint Clair Shores, Michigan, Förenta staterna, 48081
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Mississippi
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Jackson, Mississippi, Förenta staterna, 39202
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63110
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New Mexico
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Las Cruces, New Mexico, Förenta staterna, 88011
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New York
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Brooklyn, New York, Förenta staterna, 11203
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Lake Success, New York, Förenta staterna, 11042
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Manhasset, New York, Förenta staterna, 11030
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New York, New York, Förenta staterna, 10016
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Smithtown, New York, Förenta staterna, 11787
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599-7280
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Charlotte, North Carolina, Förenta staterna, 28207
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Charlotte, North Carolina, Förenta staterna, 28210
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Durham, North Carolina, Förenta staterna, 27710
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Greenville, North Carolina, Förenta staterna, 27834
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Ohio
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Cleveland, Ohio, Förenta staterna, 44109
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Columbus, Ohio, Förenta staterna, 43203
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Dayton, Ohio, Förenta staterna, 45417
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Toledo, Ohio, Förenta staterna, 43614
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73103
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Tulsa, Oklahoma, Förenta staterna, 74104
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Pennsylvania
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Bethlehem, Pennsylvania, Förenta staterna, 18015
- GSK Investigational Site
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Duncansville, Pennsylvania, Förenta staterna, 16635
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Wyomissing, Pennsylvania, Förenta staterna, 19610
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29425
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Charleston, South Carolina, Förenta staterna, 29406
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Greenville, South Carolina, Förenta staterna, 29601
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Orangeburg, South Carolina, Förenta staterna, 29118
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Tennessee
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Jackson, Tennessee, Förenta staterna, 38305
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Memphis, Tennessee, Förenta staterna, 38119
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Texas
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Allentown, Texas, Förenta staterna, 75013
- GSK Investigational Site
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Austin, Texas, Förenta staterna, 78705
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Austin, Texas, Förenta staterna, 78758
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Dallas, Texas, Förenta staterna, 75231
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Houston, Texas, Förenta staterna, 77074
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Houston, Texas, Förenta staterna, 77004
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Houston, Texas, Förenta staterna, 77008
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Houston, Texas, Förenta staterna, 77034
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Nassau Bay, Texas, Förenta staterna, 77058
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Virginia
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Arlington, Virginia, Förenta staterna, 22205-3606
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Washington
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Seattle, Washington, Förenta staterna, 98133
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Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
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Wyoming
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Pennsylvania, Wyoming, Förenta staterna, 19610
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Genova, Italien, 16132
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Toscana
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Pisa, Toscana, Italien, 56126
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Veneto
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Padova, Veneto, Italien, 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, Kroatien, 31000
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Rijeka, Kroatien, 51000
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Zagreb, Kroatien, 10000
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Kuala Lumpur, Malaysia, 59100
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Seremban, Negeri Sembilan, Malaysia, 70300
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Mexico, Mexiko, 06700
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Mexico, Mexiko, 3100
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San Luis Potosi, Mexiko, 78240
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Jalisco
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Guadalajara, Jalisco, Mexiko, 44158
- GSK Investigational Site
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Guadalajara, Jalisco, Mexiko, 44690
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Morelos
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Cuernavaca, Morelos, Mexiko, 62270
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Yucatán
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Merida, Yucatán, Mexiko, 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
- GSK Investigational Site
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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, Rumänien, 020125
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Bucharest, Rumänien, 11172
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Bucuresti, Rumänien, 020475
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Moscow, Ryska Federationen, 115522
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Saint-Petersburg, Ryska Federationen, 190068
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Yaroslavl, Ryska Federationen, 150030
- GSK Investigational Site
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Belgrade, Serbien, 11000
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Belgrade, Serbien, 11080
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Singapore, Singapore, 529889
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Barcelona, Spanien, 08036
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Barcelona, Spanien, 8035
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Granada, Spanien, 18012
- GSK Investigational Site
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Birmingham, Storbritannien, B15 2TH
- GSK Investigational Site
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London, Storbritannien, SE1 7EH
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Warwickshire
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Coventry, Warwickshire, Storbritannien, 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
- GSK Investigational Site
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Taipei, Taiwan, 100
- GSK Investigational Site
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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
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Songkla, Thailand, 90110
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Praha 2, Tjeckien, 128 50
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Zlin, Tjeckien, 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
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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, Ungern, 4032
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Zalaegerszeg, Ungern, 8900
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Vienna, Österrike, A-1100
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: 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 omfattar något av följande (enbart eller i kombination): kortikosteroider, antimalariamedel, icke-steroida antiinflammatoriska läkemedel (NSAID) och immunsuppressiva medel; Biologiska läkemedel och intravenös cyklofosfamid är inte tillåtna.
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Experimentell: 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.
|
Standardterapi omfattar något av följande (enbart eller i kombination): kortikosteroider, antimalariamedel, icke-steroida antiinflammatoriska läkemedel (NSAID) och immunsuppressiva medel; Biologiska läkemedel och intravenös cyklofosfamid är inte tillåtna.
Belimumab 200 mg SC
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
16 november 2011
Primärt slutförande (Faktisk)
13 februari 2015
Avslutad studie (Faktisk)
1 oktober 2015
Studieregistreringsdatum
Först inskickad
28 november 2011
Först inskickad som uppfyllde QC-kriterierna
30 november 2011
Första postat (Uppskatta)
2 december 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 juni 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 maj 2018
Senast verifierad
1 maj 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 112341
- 2011-003814-18
- HGS1006-C1115
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokument
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Informerat samtycke
Informationsidentifierare: 112341Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättningsspecifikation
Informationsidentifierare: 112341Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisk studierapport
Informationsidentifierare: 112341Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättning för individuella deltagare
Informationsidentifierare: 112341Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisk analysplan
Informationsidentifierare: 112341Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoterad fallrapportformulär
Informationsidentifierare: 112341Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokoll
Informationsidentifierare: 112341Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .