A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)
31 mei 2018 bijgewerkt door: 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).
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
839
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ciudad Autonoma Buenos Aires, Argentinië, C1015ABO
- GSK Investigational Site
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Ciudad Autonoma Buenos Aires, Argentinië, C1426AAL
- GSK Investigational Site
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentinië, C1419AHN
- GSK Investigational Site
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentinië, C1181ACI
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La Plata, Buenos Aires, Argentinië, B1902COS
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Brussels, België, 1090
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Bruxelles, België, 1200
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Liège, België, 4000
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Rio de Janeiro, Brazilië, 21941-913
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Salvador, Brazilië, 40050-410
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São Paulo, Brazilië, 04032-060
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Mato Grosso
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Cuiaba, Mato Grosso, Brazilië, 78005-000
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Minas Gerais
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Juiz de Fora, Minas Gerais, Brazilië, 36038-330
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Paraná
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Curitiba, Paraná, Brazilië, 80440-080
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazilië, 90035-903
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Porto Alegre, Rio Grande Do Sul, Brazilië, 90110-270
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Plovdiv, Bulgarije, 4002
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Ruse, Bulgarije, 7002
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Sofia, Bulgarije, 1784
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Santiago, Chili, 7500000
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Viña del Mar, Chili, 2570017
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Región Metro De Santiago
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Santiago, Región Metro De Santiago, Chili, 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, Denemarken, 2100
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Odense C, Denemarken, 5000
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Frankfurt, Duitsland, 60590
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Hamburg, Duitsland, 22081
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Bayern
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Wuerzburg, Bayern, Duitsland, 97080
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Hessen
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Bad Nauheim, Hessen, Duitsland, 61231
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Niedersachsen
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Hannover, Niedersachsen, Duitsland, 30625
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Nordrhein-Westfalen
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Duesseldorf, Nordrhein-Westfalen, Duitsland, 40225
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Duitsland, 55131
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Cebu City, Filippijnen, 6000
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Davao City, Filippijnen, 8000
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Iloilo City, Filippijnen, 5000
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Las Pinas, Filippijnen, 1740
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Manila, Filippijnen, 1000
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Manila, Filippijnen, 1015
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Quezon City, Filippijnen, 1102
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Quezon City, Filippijnen, 1118
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Paris, Frankrijk, 75679
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Paris cedex 13, Frankrijk, 75651
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Pessac Cedex, Frankrijk, 33604
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Strasbourg cedex, Frankrijk, 67091
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Suresnes, Frankrijk, 92150
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Vandoeuvre les Nancy, Frankrijk, 54511
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Debrecen, Hongarije, 4032
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Zalaegerszeg, Hongarije, 8900
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Genova, Italië, 16132
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Toscana
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Pisa, Toscana, Italië, 56126
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Veneto
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Padova, Veneto, Italië, 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, Kroatië, 31000
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Rijeka, Kroatië, 51000
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Zagreb, Kroatië, 10000
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Kuala Lumpur, Maleisië, 59100
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Seremban, Negeri Sembilan, Maleisië, 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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Kharkiv, Oekraïne, 61039
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Kyiv, Oekraïne, 01601
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Odesa, Oekraïne, 65026
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Poltava, Oekraïne, 36011
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Vinnytsia, Oekraïne, 21018
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Zaporizhzhia, Oekraïne, 69600
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Vienna, Oostenrijk, A-1100
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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
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Porto, Portugal, 4099-001
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Bucharest, Roemenië, 020125
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Bucharest, Roemenië, 11172
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Bucuresti, Roemenië, 020475
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Moscow, Russische Federatie, 115522
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Saint-Petersburg, Russische Federatie, 190068
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Yaroslavl, Russische Federatie, 150030
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Belgrade, Servië, 11000
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Belgrade, Servië, 11080
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Singapore, Singapore, 529889
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Barcelona, Spanje, 08036
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Barcelona, Spanje, 8035
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Granada, Spanje, 18012
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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
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Chiangmai, Thailand, 50200
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Rajathevee, Thailand, 10400
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Ratchatewi, Thailand, 10400
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Songkla, Thailand, 90110
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Praha 2, Tsjechië, 128 50
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Zlin, Tsjechië, 760 01
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Birmingham, Verenigd Koninkrijk, B15 2TH
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London, Verenigd Koninkrijk, SE1 7EH
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Warwickshire
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Coventry, Warwickshire, Verenigd Koninkrijk, CV2 2DX
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35294
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Arizona
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Peoria, Arizona, Verenigde Staten, 85381
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Tucson, Arizona, Verenigde Staten, 85712
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Tucson, Arizona, Verenigde Staten, 85724
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Arkansas
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Jonesboro, Arkansas, Verenigde Staten, 72401
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California
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La Jolla, California, Verenigde Staten, 92037-0943
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Long Beach, California, Verenigde Staten, 90806
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Los Angeles, California, Verenigde Staten, 90033
- GSK Investigational Site
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San Diego, California, Verenigde Staten, 92120
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San Francisco, California, Verenigde Staten, 94118
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San Jose, California, Verenigde Staten, 95126-1650
- GSK Investigational Site
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San Leandro, California, Verenigde Staten, 94578
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Tustin, California, Verenigde Staten, 92780
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Upland, California, Verenigde Staten, 91786
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Connecticut
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Bridgeport, Connecticut, Verenigde Staten, 06606
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Florida
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Aventura, Florida, Verenigde Staten, 33180
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Boca Raton, Florida, Verenigde Staten, 33486
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Boca Raton, Florida, Verenigde Staten, 33432
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Coral Gables, Florida, Verenigde Staten, 33134
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Fort Lauderdale, Florida, Verenigde Staten, 33334
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Miami, Florida, Verenigde Staten, 33136
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Orlando, Florida, Verenigde Staten, 32804
- GSK Investigational Site
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Orlando, Florida, Verenigde Staten, 32806-6264
- GSK Investigational Site
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Plantation, Florida, Verenigde Staten, 33324
- GSK Investigational Site
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Tampa, Florida, Verenigde Staten, 33614
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30342
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Atlanta, Georgia, Verenigde Staten, 30303
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Duluth, Georgia, Verenigde Staten, 30096
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Lawrenceville, Georgia, Verenigde Staten, 30045
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Marietta, Georgia, Verenigde Staten, 30060
- GSK Investigational Site
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Idaho
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Boise, Idaho, Verenigde Staten, 83704
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Illinois
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Springfield, Illinois, Verenigde Staten, 62704
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Louisiana
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Baton Rouge, Louisiana, Verenigde Staten, 70809
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New Orleans, Louisiana, Verenigde Staten, 70121
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21205
- GSK Investigational Site
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Cumberland, Maryland, Verenigde Staten, 21502
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Hagerstown, Maryland, Verenigde Staten, 21740
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02118
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Boston, Massachusetts, Verenigde Staten, 02115
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Michigan
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Detroit, Michigan, Verenigde Staten, 48202
- GSK Investigational Site
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Saint Clair Shores, Michigan, Verenigde Staten, 48081
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Mississippi
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Jackson, Mississippi, Verenigde Staten, 39202
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Missouri
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Saint Louis, Missouri, Verenigde Staten, 63110
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New Mexico
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Las Cruces, New Mexico, Verenigde Staten, 88011
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New York
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Brooklyn, New York, Verenigde Staten, 11203
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Lake Success, New York, Verenigde Staten, 11042
- GSK Investigational Site
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Manhasset, New York, Verenigde Staten, 11030
- GSK Investigational Site
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New York, New York, Verenigde Staten, 10016
- GSK Investigational Site
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Smithtown, New York, Verenigde Staten, 11787
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599-7280
- GSK Investigational Site
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Charlotte, North Carolina, Verenigde Staten, 28207
- GSK Investigational Site
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Charlotte, North Carolina, Verenigde Staten, 28210
- GSK Investigational Site
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Durham, North Carolina, Verenigde Staten, 27710
- GSK Investigational Site
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Greenville, North Carolina, Verenigde Staten, 27834
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44109
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Columbus, Ohio, Verenigde Staten, 43203
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Dayton, Ohio, Verenigde Staten, 45417
- GSK Investigational Site
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Toledo, Ohio, Verenigde Staten, 43614
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73103
- GSK Investigational Site
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Tulsa, Oklahoma, Verenigde Staten, 74104
- GSK Investigational Site
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Pennsylvania
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Bethlehem, Pennsylvania, Verenigde Staten, 18015
- GSK Investigational Site
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Duncansville, Pennsylvania, Verenigde Staten, 16635
- GSK Investigational Site
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Wyomissing, Pennsylvania, Verenigde Staten, 19610
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29425
- GSK Investigational Site
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Charleston, South Carolina, Verenigde Staten, 29406
- GSK Investigational Site
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Greenville, South Carolina, Verenigde Staten, 29601
- GSK Investigational Site
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Orangeburg, South Carolina, Verenigde Staten, 29118
- GSK Investigational Site
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Tennessee
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Jackson, Tennessee, Verenigde Staten, 38305
- GSK Investigational Site
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Memphis, Tennessee, Verenigde Staten, 38119
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Texas
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Allentown, Texas, Verenigde Staten, 75013
- GSK Investigational Site
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Austin, Texas, Verenigde Staten, 78705
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Austin, Texas, Verenigde Staten, 78758
- GSK Investigational Site
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Dallas, Texas, Verenigde Staten, 75231
- GSK Investigational Site
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Houston, Texas, Verenigde Staten, 77074
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Houston, Texas, Verenigde Staten, 77004
- GSK Investigational Site
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Houston, Texas, Verenigde Staten, 77008
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Houston, Texas, Verenigde Staten, 77034
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Nassau Bay, Texas, Verenigde Staten, 77058
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Virginia
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Arlington, Virginia, Verenigde Staten, 22205-3606
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Washington
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Seattle, Washington, Verenigde Staten, 98133
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Wisconsin
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Milwaukee, Wisconsin, Verenigde Staten, 53226
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Wyoming
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Pennsylvania, Wyoming, Verenigde Staten, 19610
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Göteborg, Zweden, SE-413 45
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Lund, Zweden, SE-221 85
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Stockholm, Zweden, SE-171 76
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: 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
Standaardtherapie omvat een van de volgende (alleen of in combinatie): corticosteroïden, antimalariamiddelen, niet-steroïde anti-inflammatoire geneesmiddelen (NSAID's) en immunosuppressiva; biologische geneesmiddelen en intraveneus cyclofosfamide zijn niet toegestaan.
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Experimenteel: 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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Standaardtherapie omvat een van de volgende (alleen of in combinatie): corticosteroïden, antimalariamiddelen, niet-steroïde anti-inflammatoire geneesmiddelen (NSAID's) en immunosuppressiva; biologische geneesmiddelen en intraveneus cyclofosfamide zijn niet toegestaan.
Belimumab 200 mg SC
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
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Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
16 november 2011
Primaire voltooiing (Werkelijk)
13 februari 2015
Studie voltooiing (Werkelijk)
1 oktober 2015
Studieregistratiedata
Eerst ingediend
28 november 2011
Eerst ingediend dat voldeed aan de QC-criteria
30 november 2011
Eerst geplaatst (Schatting)
2 december 2011
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 juni 2018
Laatste update ingediend die voldeed aan QC-criteria
31 mei 2018
Laatst geverifieerd
1 mei 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 112341
- 2011-003814-18
- HGS1006-C1115
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Bestudeer gegevens/documenten
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Formulier geïnformeerde toestemming
Informatie-ID: 112341Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Specificatie gegevensset
Informatie-ID: 112341Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisch onderzoeksrapport
Informatie-ID: 112341Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
-
Gegevensset individuele deelnemers
Informatie-ID: 112341Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisch analyseplan
Informatie-ID: 112341Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
-
Geannoteerd casusrapportformulier
Informatie-ID: 112341Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
-
Leerprotocool
Informatie-ID: 112341Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .