A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)
31 mai 2018 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
839
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Frankfurt, Allemagne, 60590
- GSK Investigational Site
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Hamburg, Allemagne, 22081
- GSK Investigational Site
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Bayern
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Wuerzburg, Bayern, Allemagne, 97080
- GSK Investigational Site
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Hessen
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Bad Nauheim, Hessen, Allemagne, 61231
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Allemagne, 30625
- GSK Investigational Site
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Nordrhein-Westfalen
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Duesseldorf, Nordrhein-Westfalen, Allemagne, 40225
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Allemagne, 55131
- GSK Investigational Site
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Ciudad Autonoma Buenos Aires, Argentine, C1015ABO
- GSK Investigational Site
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Ciudad Autonoma Buenos Aires, Argentine, C1426AAL
- GSK Investigational Site
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentine, C1419AHN
- GSK Investigational Site
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentine, C1181ACI
- GSK Investigational Site
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La Plata, Buenos Aires, Argentine, B1902COS
- GSK Investigational Site
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Brussels, Belgique, 1090
- GSK Investigational Site
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Bruxelles, Belgique, 1200
- GSK Investigational Site
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Liège, Belgique, 4000
- GSK Investigational Site
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Rio de Janeiro, Brésil, 21941-913
- GSK Investigational Site
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Salvador, Brésil, 40050-410
- GSK Investigational Site
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São Paulo, Brésil, 04032-060
- GSK Investigational Site
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Mato Grosso
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Cuiaba, Mato Grosso, Brésil, 78005-000
- GSK Investigational Site
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Minas Gerais
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Juiz de Fora, Minas Gerais, Brésil, 36038-330
- GSK Investigational Site
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Paraná
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Curitiba, Paraná, Brésil, 80440-080
- GSK Investigational Site
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brésil, 90035-903
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, Brésil, 90110-270
- GSK Investigational Site
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Plovdiv, Bulgarie, 4002
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Ruse, Bulgarie, 7002
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Sofia, Bulgarie, 1784
- GSK Investigational Site
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Santiago, Chili, 7500000
- GSK Investigational Site
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Viña del Mar, Chili, 2570017
- GSK Investigational Site
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Región Metro De Santiago
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Santiago, Región Metro De Santiago, Chili, 7501126
- GSK Investigational Site
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Barranquilla, Colombie
- GSK Investigational Site
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Bogota, Colombie
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Bucaramanga, Colombie
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Medellin, Colombie
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Osijek, Croatie, 31000
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Rijeka, Croatie, 51000
- GSK Investigational Site
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Zagreb, Croatie, 10000
- GSK Investigational Site
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Koebenhavn, Danemark, 2100
- GSK Investigational Site
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Odense C, Danemark, 5000
- GSK Investigational Site
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Barcelona, Espagne, 08036
- GSK Investigational Site
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Barcelona, Espagne, 8035
- GSK Investigational Site
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Granada, Espagne, 18012
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Paris, France, 75679
- GSK Investigational Site
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Paris cedex 13, France, 75651
- GSK Investigational Site
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Pessac Cedex, France, 33604
- GSK Investigational Site
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Strasbourg cedex, France, 67091
- GSK Investigational Site
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Suresnes, France, 92150
- GSK Investigational Site
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Vandoeuvre les Nancy, France, 54511
- GSK Investigational Site
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Moscow, Fédération Russe, 115522
- GSK Investigational Site
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Saint-Petersburg, Fédération Russe, 190068
- GSK Investigational Site
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Yaroslavl, Fédération Russe, 150030
- GSK Investigational Site
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Debrecen, Hongrie, 4032
- GSK Investigational Site
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Zalaegerszeg, Hongrie, 8900
- GSK Investigational Site
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Genova, Italie, 16132
- GSK Investigational Site
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Toscana
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Pisa, Toscana, Italie, 56126
- GSK Investigational Site
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Veneto
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Padova, Veneto, Italie, 35128
- GSK Investigational Site
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Fukuoka, Japon, 807-8555
- GSK Investigational Site
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Fukuoka, Japon, 810-8563
- GSK Investigational Site
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Hokkaido, Japon, 060-8648
- GSK Investigational Site
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Hokkaido, Japon, 060-8604
- GSK Investigational Site
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Miyagi, Japon, 980-8574
- GSK Investigational Site
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Nagasaki, Japon, 857-1195
- GSK Investigational Site
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Okinawa, Japon, 901-0243
- GSK Investigational Site
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Shizuoka, Japon, 430-8558
- GSK Investigational Site
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Tokyo, Japon, 160-8582
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Tokyo, Japon, 162-8655
- GSK Investigational Site
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Tokyo, Japon, 104-8560
- GSK Investigational Site
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Vienna, L'Autriche, A-1100
- GSK Investigational Site
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Almada, Le Portugal, 2801-915
- GSK Investigational Site
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Amadora, Le Portugal, 2720-276
- GSK Investigational Site
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Coimbra, Le Portugal, 3000-075
- GSK Investigational Site
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Lisboa, Le Portugal, 1649-035
- GSK Investigational Site
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Porto, Le Portugal, 4099-001
- GSK Investigational Site
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Kuala Lumpur, Malaisie, 59100
- GSK Investigational Site
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Seremban, Negeri Sembilan, Malaisie, 70300
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Mexico, Mexique, 06700
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Mexico, Mexique, 3100
- GSK Investigational Site
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San Luis Potosi, Mexique, 78240
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Jalisco
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Guadalajara, Jalisco, Mexique, 44158
- GSK Investigational Site
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Guadalajara, Jalisco, Mexique, 44690
- GSK Investigational Site
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Morelos
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Cuernavaca, Morelos, Mexique, 62270
- GSK Investigational Site
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Yucatán
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Merida, Yucatán, Mexique, 97130
- GSK Investigational Site
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Cebu City, Philippines, 6000
- GSK Investigational Site
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Davao City, Philippines, 8000
- GSK Investigational Site
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Iloilo City, Philippines, 5000
- GSK Investigational Site
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Las Pinas, Philippines, 1740
- GSK Investigational Site
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Manila, Philippines, 1000
- GSK Investigational Site
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Manila, Philippines, 1015
- GSK Investigational Site
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Quezon City, Philippines, 1102
- GSK Investigational Site
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Quezon City, Philippines, 1118
- GSK Investigational Site
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Bydgoszcz, Pologne, 85-168
- GSK Investigational Site
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Katowice, Pologne, 40-635
- GSK Investigational Site
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Krakow, Pologne, 31-066
- GSK Investigational Site
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Wroclaw, Pologne, 50-556
- GSK Investigational Site
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Bucharest, Roumanie, 020125
- GSK Investigational Site
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Bucharest, Roumanie, 11172
- GSK Investigational Site
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Bucuresti, Roumanie, 020475
- GSK Investigational Site
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Birmingham, Royaume-Uni, B15 2TH
- GSK Investigational Site
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London, Royaume-Uni, SE1 7EH
- GSK Investigational Site
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Warwickshire
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Coventry, Warwickshire, Royaume-Uni, CV2 2DX
- GSK Investigational Site
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Belgrade, Serbie, 11000
- GSK Investigational Site
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Belgrade, Serbie, 11080
- GSK Investigational Site
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Singapore, Singapour, 529889
- GSK Investigational Site
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Göteborg, Suède, SE-413 45
- GSK Investigational Site
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Lund, Suède, SE-221 85
- GSK Investigational Site
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Stockholm, Suède, SE-171 76
- GSK Investigational Site
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Gueishan Township,Taoyuan County, Taïwan, 333
- GSK Investigational Site
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Kaohsiung, Taïwan, 833
- GSK Investigational Site
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Kaohsiung, Taïwan, 813
- GSK Investigational Site
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Kaohsiung, Taïwan, 807
- GSK Investigational Site
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Taichung, Taïwan, 404
- GSK Investigational Site
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Taipei, Taïwan, 100
- GSK Investigational Site
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Praha 2, Tchéquie, 128 50
- GSK Investigational Site
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Zlin, Tchéquie, 760 01
- GSK Investigational Site
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Bangkok, Thaïlande, 10400
- GSK Investigational Site
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Bangkok, Thaïlande, 10700
- GSK Investigational Site
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Chiangmai, Thaïlande, 50200
- GSK Investigational Site
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Rajathevee, Thaïlande, 10400
- GSK Investigational Site
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Ratchatewi, Thaïlande, 10400
- GSK Investigational Site
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Songkla, Thaïlande, 90110
- GSK Investigational Site
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Kharkiv, Ukraine, 61039
- GSK Investigational Site
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Kyiv, Ukraine, 01601
- GSK Investigational Site
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Odesa, Ukraine, 65026
- GSK Investigational Site
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Poltava, Ukraine, 36011
- GSK Investigational Site
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Vinnytsia, Ukraine, 21018
- GSK Investigational Site
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Zaporizhzhia, Ukraine, 69600
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- GSK Investigational Site
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Arizona
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Peoria, Arizona, États-Unis, 85381
- GSK Investigational Site
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Tucson, Arizona, États-Unis, 85712
- GSK Investigational Site
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Tucson, Arizona, États-Unis, 85724
- GSK Investigational Site
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Arkansas
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Jonesboro, Arkansas, États-Unis, 72401
- GSK Investigational Site
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California
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La Jolla, California, États-Unis, 92037-0943
- GSK Investigational Site
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Long Beach, California, États-Unis, 90806
- GSK Investigational Site
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Los Angeles, California, États-Unis, 90033
- GSK Investigational Site
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San Diego, California, États-Unis, 92120
- GSK Investigational Site
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San Francisco, California, États-Unis, 94118
- GSK Investigational Site
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San Jose, California, États-Unis, 95126-1650
- GSK Investigational Site
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San Leandro, California, États-Unis, 94578
- GSK Investigational Site
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Tustin, California, États-Unis, 92780
- GSK Investigational Site
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Upland, California, États-Unis, 91786
- GSK Investigational Site
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Connecticut
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Bridgeport, Connecticut, États-Unis, 06606
- GSK Investigational Site
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Florida
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Aventura, Florida, États-Unis, 33180
- GSK Investigational Site
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Boca Raton, Florida, États-Unis, 33486
- GSK Investigational Site
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Boca Raton, Florida, États-Unis, 33432
- GSK Investigational Site
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Coral Gables, Florida, États-Unis, 33134
- GSK Investigational Site
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Fort Lauderdale, Florida, États-Unis, 33334
- GSK Investigational Site
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Miami, Florida, États-Unis, 33136
- GSK Investigational Site
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Orlando, Florida, États-Unis, 32804
- GSK Investigational Site
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Orlando, Florida, États-Unis, 32806-6264
- GSK Investigational Site
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Plantation, Florida, États-Unis, 33324
- GSK Investigational Site
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Tampa, Florida, États-Unis, 33614
- GSK Investigational Site
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Georgia
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Atlanta, Georgia, États-Unis, 30342
- GSK Investigational Site
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Atlanta, Georgia, États-Unis, 30303
- GSK Investigational Site
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Duluth, Georgia, États-Unis, 30096
- GSK Investigational Site
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Lawrenceville, Georgia, États-Unis, 30045
- GSK Investigational Site
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Marietta, Georgia, États-Unis, 30060
- GSK Investigational Site
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Idaho
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Boise, Idaho, États-Unis, 83704
- GSK Investigational Site
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Illinois
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Springfield, Illinois, États-Unis, 62704
- GSK Investigational Site
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Louisiana
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Baton Rouge, Louisiana, États-Unis, 70809
- GSK Investigational Site
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New Orleans, Louisiana, États-Unis, 70121
- GSK Investigational Site
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Maryland
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Baltimore, Maryland, États-Unis, 21205
- GSK Investigational Site
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Cumberland, Maryland, États-Unis, 21502
- GSK Investigational Site
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Hagerstown, Maryland, États-Unis, 21740
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- GSK Investigational Site
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Boston, Massachusetts, États-Unis, 02115
- GSK Investigational Site
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Michigan
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Detroit, Michigan, États-Unis, 48202
- GSK Investigational Site
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Saint Clair Shores, Michigan, États-Unis, 48081
- GSK Investigational Site
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Mississippi
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Jackson, Mississippi, États-Unis, 39202
- GSK Investigational Site
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Missouri
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Saint Louis, Missouri, États-Unis, 63110
- GSK Investigational Site
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New Mexico
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Las Cruces, New Mexico, États-Unis, 88011
- GSK Investigational Site
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New York
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Brooklyn, New York, États-Unis, 11203
- GSK Investigational Site
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Lake Success, New York, États-Unis, 11042
- GSK Investigational Site
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Manhasset, New York, États-Unis, 11030
- GSK Investigational Site
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New York, New York, États-Unis, 10016
- GSK Investigational Site
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Smithtown, New York, États-Unis, 11787
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599-7280
- GSK Investigational Site
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Charlotte, North Carolina, États-Unis, 28207
- GSK Investigational Site
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Charlotte, North Carolina, États-Unis, 28210
- GSK Investigational Site
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Durham, North Carolina, États-Unis, 27710
- GSK Investigational Site
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Greenville, North Carolina, États-Unis, 27834
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, États-Unis, 44109
- GSK Investigational Site
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Columbus, Ohio, États-Unis, 43203
- GSK Investigational Site
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Dayton, Ohio, États-Unis, 45417
- GSK Investigational Site
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Toledo, Ohio, États-Unis, 43614
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73103
- GSK Investigational Site
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Tulsa, Oklahoma, États-Unis, 74104
- GSK Investigational Site
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Pennsylvania
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Bethlehem, Pennsylvania, États-Unis, 18015
- GSK Investigational Site
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Duncansville, Pennsylvania, États-Unis, 16635
- GSK Investigational Site
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Wyomissing, Pennsylvania, États-Unis, 19610
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- GSK Investigational Site
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Charleston, South Carolina, États-Unis, 29406
- GSK Investigational Site
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Greenville, South Carolina, États-Unis, 29601
- GSK Investigational Site
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Orangeburg, South Carolina, États-Unis, 29118
- GSK Investigational Site
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Tennessee
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Jackson, Tennessee, États-Unis, 38305
- GSK Investigational Site
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Memphis, Tennessee, États-Unis, 38119
- GSK Investigational Site
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Texas
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Allentown, Texas, États-Unis, 75013
- GSK Investigational Site
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Austin, Texas, États-Unis, 78705
- GSK Investigational Site
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Austin, Texas, États-Unis, 78758
- GSK Investigational Site
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Dallas, Texas, États-Unis, 75231
- GSK Investigational Site
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Houston, Texas, États-Unis, 77074
- GSK Investigational Site
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Houston, Texas, États-Unis, 77004
- GSK Investigational Site
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Houston, Texas, États-Unis, 77008
- GSK Investigational Site
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Houston, Texas, États-Unis, 77034
- GSK Investigational Site
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Nassau Bay, Texas, États-Unis, 77058
- GSK Investigational Site
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Virginia
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Arlington, Virginia, États-Unis, 22205-3606
- GSK Investigational Site
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Washington
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Seattle, Washington, États-Unis, 98133
- GSK Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- GSK Investigational Site
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Wyoming
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Pennsylvania, Wyoming, États-Unis, 19610
- GSK Investigational Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- At least 18 years of age.
- Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)
Exclusion Criteria:
- Pregnant or nursing.
- Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
- Have received treatment an investigational biological agent in the past year.
- Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
- Have severe active lupus kidney disease.
- Have severe active central nervous system (CNS) lupus.
- Have required management of acute or chronic infections within the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Have a history of hypersensitivity reactions to contrast agents or biological medicines.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: 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
Le traitement standard comprend l'un des éléments suivants (seuls ou en association) : corticostéroïdes, antipaludéens, anti-inflammatoires non stéroïdiens (AINS) et immunosuppresseurs ; les produits biologiques et le cyclophosphamide intraveineux ne sont pas autorisés.
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Expérimental: 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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Le traitement standard comprend l'un des éléments suivants (seuls ou en association) : corticostéroïdes, antipaludéens, anti-inflammatoires non stéroïdiens (AINS) et immunosuppresseurs ; les produits biologiques et le cyclophosphamide intraveineux ne sont pas autorisés.
Belimumab 200 mg SC
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
16 novembre 2011
Achèvement primaire (Réel)
13 février 2015
Achèvement de l'étude (Réel)
1 octobre 2015
Dates d'inscription aux études
Première soumission
28 novembre 2011
Première soumission répondant aux critères de contrôle qualité
30 novembre 2011
Première publication (Estimation)
2 décembre 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 juin 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 mai 2018
Dernière vérification
1 mai 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 112341
- 2011-003814-18
- HGS1006-C1115
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Données/documents d'étude
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Formulaire de consentement éclairé
Identifiant des informations: 112341Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Spécification du jeu de données
Identifiant des informations: 112341Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Rapport d'étude clinique
Identifiant des informations: 112341Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Ensemble de données de participant individuel
Identifiant des informations: 112341Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Plan d'analyse statistique
Identifiant des informations: 112341Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Formulaire de rapport de cas annoté
Identifiant des informations: 112341Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Protocole d'étude
Identifiant des informations: 112341Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .