A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

PHASE3CompletedINTERVENTIONAL
Enrollment

819

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

September 30, 2009

Study Completion Date

March 31, 2010

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

Placebo

Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

DRUG

Belimumab 1 mg/kg

Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

DRUG

Belimumab 10 mg/kg

Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

Trial Locations (146)

1100

Rheumazentrum Favoriten, Vienna

1200

Cliniques Universitaires, Brussels

3000

University Hospital, Leuven

4000

CHU Sart Tilman, Liège

8036

Universitatsklinik fur innere Medizin, Graz

10003

Hopital for Joint Diseases, New York

10021

Hospital for Special Surgery, New York

10461

Montefiore Medical Center, The Bronx

10589

Schlossparkklinik, Berlin

11030

Feinstein Institute, Manhasset

11042

North Shore-LIJ Health System/Rheumatology and Allergy Clinic, Lake Success

11203

SUNY-Downstate Medical Center, Brooklyn

11787

Rheumatology Associates, Smithtown

12850

Institute of Rheumatology, Prague

13353

Charite, Berlin

14000

Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin, Mexico City

14618

AAIR Research Center, Rochester

15213

University of Pittsburgh, Pittsburgh

16635

Altoona Center for Clinical Research, Duncanville

17176

Karolinska Universitetssjukhuset, Stockholm

18012

Hospital Universitario San Cecilio, Granada

18015

East Penn Rheumatology Associates, Bethlehem

20010

Washington Hospital Center, Washington D.C.

20153

A.O. Ospedale San Carlo Borromeo, Milan

21205

Johns Hopkins University, Baltimore

21502

Osteoporosis and Clinical Trials Center, Cumberland

21740

Osteoporosis & Clinical Trials Center, Hagerstown

22205

Arthritis Clinic of Northern Virginia, P.C., Arlington

24105

Universitatsklinik Schleswig-Holstein, Campus Kiel, Kiel

27157

Wake Forest University Health Services, Winston-Salem

27834

Physicians East, PA, Greenville

28046

Hospital Universitario La Paz, Madrid

29010

Hospital Regional Universitario de SAS - Carlos Haya, Málaga

29406

Low Country Rheumatology, PA/Low Country Research Center, Charleston

29425

Medical University of South Carolina, Charleston

29601

Palmetto Clinical Trial at Piedmont Arthritis Clinic, Greenville

30303

Emory University, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

31048

B'nai-Zion Medical Center, Haifa

31059

Centre Hospitalier Universitarie (CHU) - PURPAA, Toulouse

31096

Rambam Medical Center, Haifa

32806

Rheumatology Associates of Central Florida, Orlando

33100

Azienda Ospedaliero University-Santa Maria della Misericordia, Udine

33180

Arthritis and Rheumatic Disease Specialties, Aventura

33609

Southwest Florida Clinical Research Center, Tampa

33614

Tampa Medical Group, P.A., Tampa

34362

Carmel Medical Center, Haifa

35128

Policlinico Universitario of Padova, Padua

35249

University of Alabama at Birmingham, Birmingham

40202

Kentuckiana Center for Better Bone and Joint Health, Louisville

40225

Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik, Düsseldorf

41100

Policlinico di Modena, Modena

41345

Sahlgrensja University Hospital, Gothenburg

43210

Ohio State University, Columbus

44100

A. O. Ospedaliera-Universitaria Arcispedale, Ferrara

Instituto Jalisciense de Investigacion Clinica, Jalisco

45235

"Hospital Civil de Guadalajara Fray Antonio Alcalde", Guadalajara

45408

STAT Research, Inc., Dayton

46321

Medical Specialists Clinical Research, Munster

48910

Fiechtner Research, Inc., Lansing

49100

Beilinson Hospital, Rabin Medical Center, Petah Tikva

50005

University Hospital Hradec Kralove, Hradec Králové

52170

Instituto de Seguridad Social del Estado de Mexico y Municipios, Toluca

52621

Sheba Medical Center, Ramat Gan

54650

Gundersen Clinic, Ltd., Onalaska

55131

Universitatsklinik Mainz, Mainz

59037

Hospital Huriez, Lille

60590

Universitatsklinikum Frankfurt, Frankfurt

60612

Rheumatology Associates, SC, Chicago

60637

University of Chicago Hospitals, Chicago

61231

Kerckhoff-Klink Bad Nauheim, Bad Nauheim

62500

University Hospital Brno, Brno

63110

Washington University School of Medicine, St Louis

64239

Tel-Aviv Saurasky Medical Center, Tel Aviv

66160

Kansas University Medical Center, Kansas City

67091

Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique, Stasbourg

70809

Ochsner Clinic Foundation, Baton Rouge

72076

Universitatsklinikum Tubingen, Tübingen

74104

Oklahoma Medical Research Center, Oklahoma City

Oklahoma Center For Arthritis Therapy & Research, Tulsa

76100

Kaplan Medical Center, Rehovot

77004

The Rheumatic Disease Clinical Research Center, Houston

77034

Accurate Clinical Research, Houston

77074

Houston Institute for Clinical Research, Houston

77479

Texas Research Center, Sugar Land

77520

University Hospital Olomouc, Olomouc

78232

Arthritis Center of South Texas, San Antonio

78240

"Hospital Central de S.L.P. Iganico Morones Prieto", San Luis Potosí City

78705

Walter Chase, Austin

79106

Medizinische Universitatsklinik, Freiburg im Breisgau

79905

Texas Tech University Health Sciences Center, El Paso

80910

Arthritis Associates of Colorado Springs, Colorado Springs

83704

Selah Medical Clinical Research Unit, Boise

84018

U.O. di reumatologia Presidio Ospedaliero di Scafati, Scafati

84101

Soroka University Medical Center, Beersheba

84124

Rheumatology Clinic, Salt Lake City

85253

Arizona Arthritis and Rheumatology Research, PPLC, Paradise Valley

85724

The University of Arizona Arthritis Center, Tucson

90033

University of Southern California, Los Angeles

90048

Wallace Rheumatic Study Center, Los Angeles

90095

UCLA Rheumatology, Los Angeles

90806

Valerius Medical Group & Research Ctr of Greater Long Beach, Inc., Long Beach

91054

FA Universitat Erlangen Nurnberg, Erlangen

91786

Inland Rheumatic Disease Specialties, Upland

92112

Narodny Ustav Reumatickych Chorob, Piešťany

92151

Hospital FOCH, Suresnes

92646

Talbert Medical Group, Huntington Beach

94270

CHU Hospital de Bicetre, Le Kremlin-Bicêtre

95126

Arthritis Care Center, Inc., San Jose

98133

The Seattle Arthritis Clinic, Seattle

99204

Arthritis Northwest, PLLC, Spokane

03136

University of Miami-Division of Rheumatology and Immunology, Miami

02111

Tufts - New England Medical Center, Boston

48109-0358

University of Michigan Medical Center - Regents of University of Michigan, Ann Arbor

03820

Stafford Medical Associates, PA, Dover

27599-7600

University of North Carolina at Chapel Hill, Chapel Hill

75390-8884

University of Texas - Southwestern Medical Center, Dallas

M5T 2S8

Toronto Western Hospital, Toronto

M5T2S8

Centre for Prognosis Studies in Rheaumatic Diseases, Toronto

H3G 1A4

McGill University Health Centre, Montreal General Hospital, Montreal

Unknown

Hospital Clinica Biblica, San José

07740

Friedrich Schiller Universitat, Jena

04103

Universitatsklinikum Leipzig, Leipzig

00152

A.O. San Camillo, Rome

00161

Policlinico Umberto 1, Rome

06726

Hospital General de México, Mexico City

07760

Hospital Regional 1o de Octubre - ISSSTE, Mexico City

2333ZA

Leiden University Medical Center, Leiden

6229HX

University Medical Center Maastricht, Maastricht

3015CE

Erasmus Medical Center, Rotterdam

3083AN

Ikazia Ziekenhuis, Rotterdam

85-168

Szpital Uniwerytecki nr Zim. dr. Jana Biziela, Bydgoszcz

26-200

Szpital Specjalistyczny Sw. Lukasza, Gmina Końskie

30-510

Malopolskie Centrum Medyczne, Krakow

20-022

Gabinety Profesorow Osrodek Baden Klinicznych, Lublin

02-637

Klinika Reumatologii im Prof. Eleonory Reicher, Warsaw

50-556

Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych, Wroclaw

00716

Ponce School of Medicine, Ponce

00935

University of Puerto Rico Medical Center, Rio Piedras

011170

"Spitalul Clinic Sf Maria", Bucharest

020125

Spitalul Clinic Colentina, Bucharest

08035

Hospital La Vall d'Hebron, Barcelona

08036

Hospital Clinic i Provincial Barcelona, Barcelona

07014

Hospital Son Dureta, Mallorca

SE17EH

St. Thomas Hospital, London

NE77DN

Freeman Hospital, Newcastle upon Tyne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Human Genome Sciences Inc.

INDUSTRY