A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

NCT ID: NCT00410384

Last Updated: 2017-02-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

819 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Belimumab 1 mg/kg

Belimumab 1 mg/kg

Group Type EXPERIMENTAL

Belimumab 1 mg/kg

Intervention Type DRUG

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.

Belimumab 10 mg/kg

Belimumab 10 mg/kg

Group Type EXPERIMENTAL

Belimumab 10 mg/kg

Intervention Type DRUG

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.

Interventions

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Placebo

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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LymphoStat-B™ belimumab LymphoStat-B™ belimumab

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of SLE by ACR criteria.
* Active SLE disease.
* Autoantibody-positive.
* On stable SLE treatment regimen.

Exclusion Criteria

* Pregnant or nursing
* Have received treatment with any B cell targeted therapy.
* Have received treatment with a biological investigational agent in the past year.
* Have received IV cyclophosphamide within 180 days of Day 0.
* Have severe lupus kidney disease.
* Have 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 historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Human Genome Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

Human Genome Sciences Inc.

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Arizona Arthritis and Rheumatology Research, PPLC

Paradise Valley, Arizona, United States

Site Status

The University of Arizona Arthritis Center

Tucson, Arizona, United States

Site Status

Talbert Medical Group

Huntington Beach, California, United States

Site Status

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

Long Beach, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

Wallace Rheumatic Study Center

Los Angeles, California, United States

Site Status

UCLA Rheumatology

Los Angeles, California, United States

Site Status

Arthritis Care Center, Inc.

San Jose, California, United States

Site Status

Inland Rheumatic Disease Specialties

Upland, California, United States

Site Status

Arthritis Associates of Colorado Springs

Colorado Springs, Colorado, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Arthritis and Rheumatic Disease Specialties

Aventura, Florida, United States

Site Status

University of Miami-Division of Rheumatology and Immunology

Miami, Florida, United States

Site Status

Rheumatology Associates of Central Florida

Orlando, Florida, United States

Site Status

Southwest Florida Clinical Research Center

Tampa, Florida, United States

Site Status

Tampa Medical Group, P.A.

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Selah Medical Clinical Research Unit

Boise, Idaho, United States

Site Status

Rheumatology Associates, SC

Chicago, Illinois, United States

Site Status

University of Chicago Hospitals

Chicago, Illinois, United States

Site Status

Medical Specialists Clinical Research

Munster, Indiana, United States

Site Status

Kansas University Medical Center

Kansas City, Kansas, United States

Site Status

Kentuckiana Center for Better Bone and Joint Health

Louisville, Kentucky, United States

Site Status

Ochsner Clinic Foundation

Baton Rouge, Louisiana, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Osteoporosis and Clinical Trials Center

Cumberland, Maryland, United States

Site Status

Osteoporosis & Clinical Trials Center

Hagerstown, Maryland, United States

Site Status

Tufts - New England Medical Center

Boston, Massachusetts, United States

Site Status

University of Michigan Medical Center - Regents of University of Michigan

Ann Arbor, Michigan, United States

Site Status

Fiechtner Research, Inc.

Lansing, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Stafford Medical Associates, PA

Dover, New Hampshire, United States

Site Status

SUNY-Downstate Medical Center

Brooklyn, New York, United States

Site Status

North Shore-LIJ Health System/Rheumatology and Allergy Clinic

Lake Success, New York, United States

Site Status

Feinstein Institute

Manhasset, New York, United States

Site Status

Hopital for Joint Diseases

New York, New York, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

AAIR Research Center

Rochester, New York, United States

Site Status

Rheumatology Associates

Smithtown, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Physicians East, PA

Greenville, North Carolina, United States

Site Status

Wake Forest University Health Services

Winston-Salem, North Carolina, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

STAT Research, Inc.

Dayton, Ohio, United States

Site Status

Oklahoma Medical Research Center

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Center For Arthritis Therapy & Research

Tulsa, Oklahoma, United States

Site Status

East Penn Rheumatology Associates

Bethlehem, Pennsylvania, United States

Site Status

Altoona Center for Clinical Research

Duncanville, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Low Country Rheumatology, PA/Low Country Research Center

Charleston, South Carolina, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Palmetto Clinical Trial at Piedmont Arthritis Clinic

Greenville, South Carolina, United States

Site Status

Walter Chase

Austin, Texas, United States

Site Status

University of Texas - Southwestern Medical Center

Dallas, Texas, United States

Site Status

Texas Tech University Health Sciences Center

El Paso, Texas, United States

Site Status

The Rheumatic Disease Clinical Research Center

Houston, Texas, United States

Site Status

Accurate Clinical Research

Houston, Texas, United States

Site Status

Houston Institute for Clinical Research

Houston, Texas, United States

Site Status

Arthritis Center of South Texas

San Antonio, Texas, United States

Site Status

Texas Research Center

Sugar Land, Texas, United States

Site Status

Rheumatology Clinic

Salt Lake City, Utah, United States

Site Status

Arthritis Clinic of Northern Virginia, P.C.

Arlington, Virginia, United States

Site Status

The Seattle Arthritis Clinic

Seattle, Washington, United States

Site Status

Arthritis Northwest, PLLC

Spokane, Washington, United States

Site Status

Gundersen Clinic, Ltd.

Onalaska, Wisconsin, United States

Site Status

Universitatsklinik fur innere Medizin

Graz, , Austria

Site Status

Rheumazentrum Favoriten

Vienna, , Austria

Site Status

Cliniques Universitaires

Brussels, , Belgium

Site Status

University Hospital

Leuven, , Belgium

Site Status

CHU Sart Tilman

Liège, , Belgium

Site Status

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Centre for Prognosis Studies in Rheaumatic Diseases

Toronto, Ontario, Canada

Site Status

McGill University Health Centre, Montreal General Hospital

Montreal, , Canada

Site Status

Hospital Clinica Biblica

San José, , Costa Rica

Site Status

University Hospital Brno

Brno, , Czechia

Site Status

University Hospital Hradec Kralove

Hradec Králové, , Czechia

Site Status

University Hospital Olomouc

Olomouc, , Czechia

Site Status

Institute of Rheumatology

Prague, , Czechia

Site Status

CHU Hospital de Bicetre

Le Kremlin-Bicêtre, , France

Site Status

Hospital Huriez

Lille, , France

Site Status

Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique

Stasbourg, , France

Site Status

Hospital FOCH

Suresnes, , France

Site Status

Centre Hospitalier Universitarie (CHU) - PURPAA

Toulouse, , France

Site Status

Kerckhoff-Klink Bad Nauheim

Bad Nauheim, , Germany

Site Status

Schlossparkklinik

Berlin, , Germany

Site Status

Charite

Berlin, , Germany

Site Status

Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik

Düsseldorf, , Germany

Site Status

FA Universitat Erlangen Nurnberg

Erlangen, , Germany

Site Status

Universitatsklinikum Frankfurt

Frankfurt, , Germany

Site Status

Medizinische Universitatsklinik

Freiburg im Breisgau, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Friedrich Schiller Universitat

Jena, , Germany

Site Status

Universitatsklinik Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status

Universitatsklinikum Leipzig

Leipzig, , Germany

Site Status

Universitatsklinik Mainz

Mainz, , Germany

Site Status

Universitatsklinikum Tubingen

Tübingen, , Germany

Site Status

Soroka University Medical Center

Beersheba, , Israel

Site Status

B'nai-Zion Medical Center

Haifa, , Israel

Site Status

Rambam Medical Center

Haifa, , Israel

Site Status

Carmel Medical Center

Haifa, , Israel

Site Status

Beilinson Hospital, Rabin Medical Center

Petah Tikva, , Israel

Site Status

Sheba Medical Center

Ramat Gan, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

Tel-Aviv Saurasky Medical Center

Tel Aviv, , Israel

Site Status

A. O. Ospedaliera-Universitaria Arcispedale

Ferrara, , Italy

Site Status

A.O. Ospedale San Carlo Borromeo

Milan, , Italy

Site Status

Policlinico di Modena

Modena, , Italy

Site Status

Policlinico Universitario of Padova

Padua, , Italy

Site Status

A.O. San Camillo

Rome, , Italy

Site Status

Policlinico Umberto 1

Rome, , Italy

Site Status

U.O. di reumatologia Presidio Ospedaliero di Scafati

Scafati, , Italy

Site Status

Azienda Ospedaliero University-Santa Maria della Misericordia

Udine, , Italy

Site Status

Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, , Mexico

Site Status

Instituto Jalisciense de Investigacion Clinica

Jalisco, , Mexico

Site Status

Hospital General de México

Mexico City, , Mexico

Site Status

Hospital Regional 1o de Octubre - ISSSTE

Mexico City, , Mexico

Site Status

Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin

Mexico City, , Mexico

Site Status

Hospital Central de S.L.P. "Iganico Morones Prieto"

San Luis Potosí City, , Mexico

Site Status

Instituto de Seguridad Social del Estado de Mexico y Municipios

Toluca, , Mexico

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

University Medical Center Maastricht

Maastricht, , Netherlands

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Ikazia Ziekenhuis

Rotterdam, , Netherlands

Site Status

Szpital Uniwerytecki nr Zim. dr. Jana Biziela

Bydgoszcz, , Poland

Site Status

Szpital Specjalistyczny Sw. Lukasza

Gmina Końskie, , Poland

Site Status

Malopolskie Centrum Medyczne

Krakow, , Poland

Site Status

Gabinety Profesorow Osrodek Baden Klinicznych

Lublin, , Poland

Site Status

Klinika Reumatologii im Prof. Eleonory Reicher

Warsaw, , Poland

Site Status

Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych

Wroclaw, , Poland

Site Status

Ponce School of Medicine

Ponce, , Puerto Rico

Site Status

University of Puerto Rico Medical Center

Rio Piedras, , Puerto Rico

Site Status

Spitalul Clinic "Sf Maria"

Bucharest, , Romania

Site Status

Spitalul Clinic Colentina

Bucharest, , Romania

Site Status

Narodny Ustav Reumatickych Chorob

Piešťany, , Slovakia

Site Status

Hospital La Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Clinic i Provincial Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario San Cecilio

Granada, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Son Dureta

Mallorca, , Spain

Site Status

Hospital Regional Universitario de SAS - Carlos Haya

Málaga, , Spain

Site Status

Sahlgrensja University Hospital

Gothenburg, , Sweden

Site Status

Karolinska Universitetssjukhuset

Stockholm, , Sweden

Site Status

St. Thomas Hospital

London, , United Kingdom

Site Status

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States Austria Belgium Canada Costa Rica Czechia France Germany Israel Italy Mexico Netherlands Poland Puerto Rico Romania Slovakia Spain Sweden United Kingdom

References

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Botto J, Cetrez N, Nikolopoulos D, Regardt M, Heintz E, Lindblom J, Parodis I. Predicting EQ-5D full health state in systemic lupus erythematosus using machine learning algorithms. Rheumatol Adv Pract. 2025 Apr 18;9(2):rkaf032. doi: 10.1093/rap/rkaf032. eCollection 2025.

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Nikolopoulos D, Cetrez N, Lindblom J, Parodis I. Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials. Rheumatol Int. 2024 Sep;44(9):1679-1689. doi: 10.1007/s00296-024-05667-5. Epub 2024 Aug 8.

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Arends EJ, Zlei M, Tipton CM, Cotic J, Osmani Z, de Bie FJ, Kamerling SWA, van Maurik A, Dimelow R, Gregan YI, Fox NL, Rabelink TJ, Roth DA, Sanz I, van Dongen JJM, van Kooten C, Teng YKO. Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2024 Sep 1;63(9):2387-2398. doi: 10.1093/rheumatology/keae286.

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Jagerback S, Gomez A, Parodis I. Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab. Rheumatology (Oxford). 2025 Feb 1;64(2):623-631. doi: 10.1093/rheumatology/keae023.

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Gomez A, Jagerback S, Sjowall C, Parodis I. Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials. Rheumatology (Oxford). 2024 Feb 1;63(2):338-348. doi: 10.1093/rheumatology/kead253.

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PMID: 37228028 (View on PubMed)

Emamikia S, Oon S, Gomez A, Lindblom J, Borg A, Enman Y, Morand E, Grannas D, van Vollenhoven RF, Nikpour M, Parodis I. Impact of remission and low disease activity on health-related quality of life in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2022 Nov 28;61(12):4752-4762. doi: 10.1093/rheumatology/keac185.

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PMID: 35302581 (View on PubMed)

Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.

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PMID: 34741731 (View on PubMed)

Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.

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PMID: 34628605 (View on PubMed)

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.

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PMID: 34531304 (View on PubMed)

Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). J Patient Rep Outcomes. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x.

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PMID: 33830377 (View on PubMed)

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.

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PMID: 33568389 (View on PubMed)

Gomez A, Hani Butrus F, Johansson P, Akerstrom E, Soukka S, Emamikia S, Enman Y, Pettersson S, Parodis I. Impact of overweight and obesity on patient-reported health-related quality of life in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Mar 2;60(3):1260-1272. doi: 10.1093/rheumatology/keaa453.

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PMID: 32918459 (View on PubMed)

van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.

Reference Type DERIVED
PMID: 31302695 (View on PubMed)

Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States. Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 Apr 25.

Reference Type DERIVED
PMID: 29409143 (View on PubMed)

Furie R, Petri MA, Strand V, Gladman DD, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials. Lupus Sci Med. 2014 Jun 26;1(1):e000031. doi: 10.1136/lupus-2014-000031. eCollection 2014.

Reference Type DERIVED
PMID: 25396065 (View on PubMed)

Petri MA, van Vollenhoven RF, Buyon J, Levy RA, Navarra SV, Cervera R, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013 Aug;65(8):2143-53. doi: 10.1002/art.37995.

Reference Type DERIVED
PMID: 23754628 (View on PubMed)

Strand V, Levy RA, Cervera R, Petri MA, Birch H, Freimuth WW, Zhong ZJ, Clarke AE; BLISS-52 and -76 Study Groups. Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials. Ann Rheum Dis. 2014 May;73(5):838-44. doi: 10.1136/annrheumdis-2012-202865. Epub 2013 Mar 22.

Reference Type DERIVED
PMID: 23524886 (View on PubMed)

Wallace DJ, Navarra S, Petri MA, Gallacher A, Thomas M, Furie R, Levy RA, van Vollenhoven RF, Cooper S, Zhong ZJ, Freimuth W, Cervera R; BLISS-52 and -76, and LBSL02 Study Groups. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013 Feb;22(2):144-54. doi: 10.1177/0961203312469259. Epub 2012 Dec 4.

Reference Type DERIVED
PMID: 23213069 (View on PubMed)

Chatham WW, Wallace DJ, Stohl W, Latinis KM, Manzi S, McCune WJ, Tegzova D, McKay JD, Avila-Armengol HE, Utset TO, Zhong ZJ, Hough DR, Freimuth WW, Migone TS; BLISS-76 Study Group. Effect of belimumab on vaccine antigen antibodies to influenza, pneumococcal, and tetanus vaccines in patients with systemic lupus erythematosus in the BLISS-76 trial. J Rheumatol. 2012 Aug;39(8):1632-40. doi: 10.3899/jrheum.111587. Epub 2012 Jun 15.

Reference Type DERIVED
PMID: 22707609 (View on PubMed)

van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, Zhong ZJ, Freimuth W. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 Aug;71(8):1343-9. doi: 10.1136/annrheumdis-2011-200937. Epub 2012 Feb 15.

Reference Type DERIVED
PMID: 22337213 (View on PubMed)

Stohl W, Hiepe F, Latinis KM, Thomas M, Scheinberg MA, Clarke A, Aranow C, Wellborne FR, Abud-Mendoza C, Hough DR, Pineda L, Migone TS, Zhong ZJ, Freimuth WW, Chatham WW; BLISS-52 Study Group; BLISS-76 Study Group. Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Jul;64(7):2328-37. doi: 10.1002/art.34400.

Reference Type DERIVED
PMID: 22275291 (View on PubMed)

Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzova D, Sanchez-Guerrero J, Schwarting A, Merrill JT, Chatham WW, Stohl W, Ginzler EM, Hough DR, Zhong ZJ, Freimuth W, van Vollenhoven RF; BLISS-76 Study Group. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011 Dec;63(12):3918-30. doi: 10.1002/art.30613.

Reference Type DERIVED
PMID: 22127708 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BLISS-76

Identifier Type: -

Identifier Source: secondary_id

110751

Identifier Type: OTHER

Identifier Source: secondary_id

HGS1006-C1056

Identifier Type: -

Identifier Source: org_study_id

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