Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)

PHASE4CompletedINTERVENTIONAL
Enrollment

503

Participants

Timeline

Start Date

February 19, 2013

Primary Completion Date

June 18, 2018

Study Completion Date

January 28, 2019

Conditions
Systemic Lupus Erythematosus
Interventions
BIOLOGICAL

Placebo plus standard therapy

Placebo plus standard therapy

BIOLOGICAL

Belimumab 10 mg/kg plus standard therapy

Belimumab 10mg/kg plus standard therapy

DRUG

Standard therapy

Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.

Trial Locations (96)

574

GSK Investigational Site, Medellín

2013

GSK Investigational Site, Diepkloof

2193

GSK Investigational Site, Johannesburg

4319

GSK Investigational Site, Durban

7500

GSK Investigational Site, Panorama / Cape Town

10016

GSK Investigational Site, New York

10029

GSK Investigational Site, New York

10032

GSK Investigational Site, New York

11021

GSK Investigational Site, Great Neck

11030

GSK Investigational Site, Manhasset

11201

GSK Investigational Site, Brooklyn

11203

GSK Investigational Site, Brooklyn

11215

GSK Investigational Site, Brooklyn

19610

GSK Investigational Site, Wyomissing

20060

GSK Investigational Site, Washington D.C.

27599

GSK Investigational Site, Chapel Hill

27617

GSK Investigational Site, Raleigh

27834

GSK Investigational Site, Greenville

28210

GSK Investigational Site, Charlotte

28401

GSK Investigational Site, Wilmington

29204

GSK Investigational Site, Columbia

29229

GSK Investigational Site, Columbia

29425

GSK Investigational Site, Charleston

30096

GSK Investigational Site, Duluth

30303

GSK Investigational Site, Atlanta

32713

GSK Investigational Site, DeBary

32750

GSK Investigational Site, Longwood

32804

GSK Investigational Site, Orlando

33014

GSK Investigational Site, Miami Lakes

33136

GSK Investigational Site, Miami

33144

GSK Investigational Site, Miami

33180

GSK Investigational Site, Aventura

33321

GSK Investigational Site, Tamarac

33324

GSK Investigational Site, Plantation

33334

GSK Investigational Site, Fort Lauderdale

33603

GSK Investigational Site, Tampa

35216

GSK Investigational Site, Birmingham

38119

GSK Investigational Site, Memphis

38163

GSK Investigational Site, Memphis

38305

GSK Investigational Site, Jackson

39216

GSK Investigational Site, Jackson

43203

GSK Investigational Site, Columbus

44195

GSK Investigational Site, Cleveland

48202

GSK Investigational Site, Detroit

48917

GSK Investigational Site, Lansing

60612

GSK Investigational Site, Chicago

63110

GSK Investigational Site, St Louis

70809

GSK Investigational Site, Baton Rouge

75014

GSK Investigational Site, Paris

75018

GSK Investigational Site, Paris

75246

GSK Investigational Site, Dallas

77004

GSK Investigational Site, Houston

77034

GSK Investigational Site, Houston

77382

GSK Investigational Site, The Woodlands

78705

GSK Investigational Site, Austin

78731

GSK Investigational Site, Austin

89102

GSK Investigational Site, Las Vegas

89128

GSK Investigational Site, Las Vegas

90048

GSK Investigational Site, Los Angeles

90623

GSK Investigational Site, La Palma

90712

GSK Investigational Site, Lakewood

90720

GSK Investigational Site, Los Alamitos

91723

GSK Investigational Site, Covina

91786

GSK Investigational Site, Upland

92563

GSK Investigational Site, Murrieta

97261

GSK Investigational Site, Fort de France

680005

GSK Investigational Site, Bucaramanga

760007

GSK Investigational Site, Santiago de Cali

90610000

GSK Investigational Site, Porto Alegre

06606

GSK Investigational Site, Bridgeport

32806-6264

GSK Investigational Site, Orlando

02115

GSK Investigational Site, Boston

07012

GSK Investigational Site, Clifton

75390-8550

GSK Investigational Site, Dallas

22205-3606

GSK Investigational Site, Arlington

40.050-410

GSK Investigational Site, Salvador

78048-902

GSK Investigational Site, Cuiabá

36010-570

GSK Investigational Site, Juiz de Fora

80440-080

GSK Investigational Site, Curitba

90035-001

GSK Investigational Site, Porto Alegre

90035-170

GSK Investigational Site, Porto Alegre

13015-001

GSK Investigational Site, Campinas

09190-615

GSK Investigational Site, Santo André

30150-221

GSK Investigational Site, Belo Horizonte, Minas Gerais

79080-190

GSK Investigational Site, Campo Grande

22411-001

GSK Investigational Site, Rio de Janeiro

01323-020

GSK Investigational Site, São Paulo

04032-060

GSK Investigational Site, São Paulo

04039-901

GSK Investigational Site, São Paulo

05652-900

GSK Investigational Site, São Paulo

080002

GSK Investigational Site, Barranquilla

SS165NL

GSK Investigational Site, Basildon

E1 1BB

GSK Investigational Site, London

SE1 7RT

GSK Investigational Site, London

WC1E 6JF

GSK Investigational Site, London

M13 9WL

GSK Investigational Site, Manchester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Human Genome Sciences Inc., a GSK Company

INDUSTRY

NCT01632241 - Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) | Biotech Hunter | Biotech Hunter