A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)

PHASE3CompletedINTERVENTIONAL
Enrollment

839

Participants

Timeline

Start Date

November 16, 2011

Primary Completion Date

February 13, 2015

Study Completion Date

October 1, 2015

Conditions
Systemic Lupus Erythematosus
Interventions
BIOLOGICAL

Placebo

Placebo

BIOLOGICAL

Belimumab 200 mg SC

Belimumab 200 mg SC

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 (207)

100

GSK Investigational Site, Taipei

333

GSK Investigational Site, Gueishan Township,Taoyuan County

404

GSK Investigational Site, Taichung

807

GSK Investigational Site, Kaohsiung City

813

GSK Investigational Site, Kaohsiung City

833

GSK Investigational Site, Kaohsiung City

1000

GSK Investigational Site, Manila

1015

GSK Investigational Site, Manila

1090

GSK Investigational Site, Brussels

1102

GSK Investigational Site, Quezon City

1118

GSK Investigational Site, Quezon City

1200

GSK Investigational Site, Brussels

1740

GSK Investigational Site, Las Piñas

1784

GSK Investigational Site, Sofia

2100

GSK Investigational Site, Copenhagen

3100

GSK Investigational Site, México

4000

GSK Investigational Site, Liège

4002

GSK Investigational Site, Plovdiv

4032

GSK Investigational Site, Debrecen

5000

GSK Investigational Site, Odense C

GSK Investigational Site, Iloilo City

6000

GSK Investigational Site, Cebu City

7002

GSK Investigational Site, Rousse

8000

GSK Investigational Site, Davao City

8035

GSK Investigational Site, Barcelona

8900

GSK Investigational Site, Zalaegerszeg

10000

GSK Investigational Site, Zagreb

10016

GSK Investigational Site, New York

10400

GSK Investigational Site, Bangkok

GSK Investigational Site, Rajathevee

GSK Investigational Site, Ratchatewi

10700

GSK Investigational Site, Bangkok

11000

GSK Investigational Site, Belgrade

11030

GSK Investigational Site, Manhasset

11042

GSK Investigational Site, Lake Success

11080

GSK Investigational Site, Belgrade

11172

GSK Investigational Site, Bucharest

11203

GSK Investigational Site, Brooklyn

11787

GSK Investigational Site, Smithtown

16132

GSK Investigational Site, Genova

16635

GSK Investigational Site, Duncansville

18012

GSK Investigational Site, Granada

18015

GSK Investigational Site, Bethlehem

19610

GSK Investigational Site, Wyomissing

GSK Investigational Site, Pennsylvania

21018

GSK Investigational Site, Vinnytsia

21205

GSK Investigational Site, Baltimore

21502

GSK Investigational Site, Cumberland

21740

GSK Investigational Site, Hagerstown

22081

GSK Investigational Site, Hamburg

27710

GSK Investigational Site, Durham

27834

GSK Investigational Site, Greenville

28207

GSK Investigational Site, Charlotte

28210

GSK Investigational Site, Charlotte

29118

GSK Investigational Site, Orangeburg

29406

GSK Investigational Site, Charleston

29425

GSK Investigational Site, Charleston

29601

GSK Investigational Site, Greenville

30045

GSK Investigational Site, Lawrenceville

30060

GSK Investigational Site, Marietta

30096

GSK Investigational Site, Duluth

30303

GSK Investigational Site, Atlanta

30342

GSK Investigational Site, Atlanta

30625

GSK Investigational Site, Hanover

31000

GSK Investigational Site, Osijek

32804

GSK Investigational Site, Orlando

33134

GSK Investigational Site, Coral Gables

33136

GSK Investigational Site, Miami

33180

GSK Investigational Site, Aventura

33324

GSK Investigational Site, Plantation

33334

GSK Investigational Site, Fort Lauderdale

33432

GSK Investigational Site, Boca Raton

33486

GSK Investigational Site, Boca Raton

33604

GSK Investigational Site, Pessac

33614

GSK Investigational Site, Tampa

35128

GSK Investigational Site, Padua

35294

GSK Investigational Site, Birmingham

36011

GSK Investigational Site, Poltava

38119

GSK Investigational Site, Memphis

38305

GSK Investigational Site, Jackson

39202

GSK Investigational Site, Jackson

40225

GSK Investigational Site, Düsseldorf

43203

GSK Investigational Site, Columbus

43614

GSK Investigational Site, Toledo

44109

GSK Investigational Site, Cleveland

44158

GSK Investigational Site, Guadalajara

44690

GSK Investigational Site, Guadalajara

45417

GSK Investigational Site, Dayton

48081

GSK Investigational Site, Saint Clair Shores

48202

GSK Investigational Site, Detroit

50200

GSK Investigational Site, Chiang Mai

51000

GSK Investigational Site, Rijeka

53226

GSK Investigational Site, Milwaukee

54511

GSK Investigational Site, Vandœuvre-lès-Nancy

55131

GSK Investigational Site, Mainz

56126

GSK Investigational Site, Pisa

59100

GSK Investigational Site, Kuala Lumpur

60590

GSK Investigational Site, Frankfurt

61039

GSK Investigational Site, Kharkiv

61231

GSK Investigational Site, Bad Nauheim

62270

GSK Investigational Site, Cuernavaca

62704

GSK Investigational Site, Springfield

63110

GSK Investigational Site, St Louis

65026

GSK Investigational Site, Odesa

67091

GSK Investigational Site, Strasbourg

69600

GSK Investigational Site, Zaporizhzhia

70121

GSK Investigational Site, New Orleans

70300

GSK Investigational Site, Seremban, Negeri Sembilan

70809

GSK Investigational Site, Baton Rouge

72401

GSK Investigational Site, Jonesboro

73103

GSK Investigational Site, Oklahoma City

74104

GSK Investigational Site, Tulsa

75013

GSK Investigational Site, Royalty

75231

GSK Investigational Site, Dallas

75651

GSK Investigational Site, Paris

75679

GSK Investigational Site, Paris

77004

GSK Investigational Site, Houston

77008

GSK Investigational Site, Houston

77034

GSK Investigational Site, Houston

77058

GSK Investigational Site, Nassau Bay

77074

GSK Investigational Site, Houston

78240

GSK Investigational Site, San Luis Potosí City

78705

GSK Investigational Site, Austin

78758

GSK Investigational Site, Austin

83704

GSK Investigational Site, Boise

85381

GSK Investigational Site, Peoria

85712

GSK Investigational Site, Tucson

85724

GSK Investigational Site, Tucson

88011

GSK Investigational Site, Las Cruces

90033

GSK Investigational Site, Los Angeles

90110

GSK Investigational Site, Songkhla

90806

GSK Investigational Site, Long Beach

91786

GSK Investigational Site, Upland

92120

GSK Investigational Site, San Diego

92150

GSK Investigational Site, Suresnes

92780

GSK Investigational Site, Tustin

94118

GSK Investigational Site, San Francisco

94578

GSK Investigational Site, San Leandro

97080

GSK Investigational Site, Würzburg

97130

GSK Investigational Site, Mérida

98133

GSK Investigational Site, Seattle

115522

GSK Investigational Site, Moscow

150030

GSK Investigational Site, Yaroslavl

190068

GSK Investigational Site, Saint Petersburg

529889

GSK Investigational Site, Singapore

2570017

GSK Investigational Site, Viña del Mar

7500000

GSK Investigational Site, Santiago

7501126

GSK Investigational Site, Santiago

92037-0943

GSK Investigational Site, La Jolla

95126-1650

GSK Investigational Site, San Jose

06606

GSK Investigational Site, Bridgeport

32806-6264

GSK Investigational Site, Orlando

02115

GSK Investigational Site, Boston

02118

GSK Investigational Site, Boston

27599-7280

GSK Investigational Site, Chapel Hill

22205-3606

GSK Investigational Site, Arlington

C1181ACI

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

C1419AHN

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

B1902COS

GSK Investigational Site, La Plata

C1015ABO

GSK Investigational Site, Ciudad Autonoma Buenos Aires

C1426AAL

GSK Investigational Site, Ciudad Autonoma Buenos Aires

A-1100

GSK Investigational Site, Vienna

78005-000

GSK Investigational Site, Cuiabá

36038-330

GSK Investigational Site, Juiz de Fora

80440-080

GSK Investigational Site, Curitiba

90035-903

GSK Investigational Site, Porto Alegre

90110-270

GSK Investigational Site, Porto Alegre

21941-913

GSK Investigational Site, Rio de Janeiro

40050-410

GSK Investigational Site, Salvador

04032-060

GSK Investigational Site, São Paulo

Unknown

GSK Investigational Site, Barranquilla

GSK Investigational Site, Bogotá

GSK Investigational Site, Bucaramanga

GSK Investigational Site, Medellín

128 50

GSK Investigational Site, Prague

760 01

GSK Investigational Site, Zlín

807-8555

GSK Investigational Site, Fukuoka

810-8563

GSK Investigational Site, Fukuoka

060-8604

GSK Investigational Site, Hokkaido

060-8648

GSK Investigational Site, Hokkaido

980-8574

GSK Investigational Site, Miyagi

857-1195

GSK Investigational Site, Nagasaki

901-0243

GSK Investigational Site, Okinawa

430-8558

GSK Investigational Site, Shizuoka

104-8560

GSK Investigational Site, Tokyo

160-8582

GSK Investigational Site, Tokyo

162-8655

GSK Investigational Site, Tokyo

06700

GSK Investigational Site, México

85-168

GSK Investigational Site, Bydgoszcz

40-635

GSK Investigational Site, Katowice

31-066

GSK Investigational Site, Krakow

50-556

GSK Investigational Site, Wroclaw

2801-915

GSK Investigational Site, Almada

2720-276

GSK Investigational Site, Amadora

3000-075

GSK Investigational Site, Coimbra

1649-035

GSK Investigational Site, Lisbon

4099-001

GSK Investigational Site, Porto

020125

GSK Investigational Site, Bucharest

020475

GSK Investigational Site, Bucharest

08036

GSK Investigational Site, Barcelona

SE-413 45

GSK Investigational Site, Gothenburg

SE-221 85

GSK Investigational Site, Lund

SE-171 76

GSK Investigational Site, Stockholm

01601

GSK Investigational Site, Kyiv

CV2 2DX

GSK Investigational Site, Coventry

B15 2TH

GSK Investigational Site, Birmingham

SE1 7EH

GSK Investigational Site, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Human Genome Sciences Inc., a GSK Company

INDUSTRY

NCT01484496 - A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) | Biotech Hunter | Biotech Hunter