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Systemic Lupus ErythematosusPhase 3BLISS-76NCT00410384

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

A Phase 3 study testing Belimumab 1 mg/kg and Belimumab 10 mg/kg in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc. at 146 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Belimumab 1 mg/kg and Belimumab 10 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
819 participants
Where
146 sitesin 19 countries
Study dates
Dec 2006to Mar 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

146 sites in 19 countries.

146 sites in 19 countries

United States67 sites

  • University of Michigan Medical Center - Regents of University of Michigan

    Ann Arbor, Michigan, 48109-0358

  • Arthritis Clinic of Northern Virginia, P.C.

    Arlington, Virginia, 22205

  • Emory University

    Atlanta, Georgia, 30303

  • Walter Chase

    Austin, Texas, 78705

  • Arthritis and Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Ochsner Clinic Foundation

    Baton Rouge, Louisiana, 70809

  • East Penn Rheumatology Associates

    Bethlehem, Pennsylvania, 18015

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Selah Medical Clinical Research Unit

    Boise, Idaho, 83704

  • Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • SUNY-Downstate Medical Center

    Brooklyn, New York, 11203

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7600

  • Low Country Rheumatology, PA/Low Country Research Center

    Charleston, South Carolina, 29406

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Rheumatology Associates, SC

    Chicago, Illinois, 60612

  • University of Chicago Hospitals

    Chicago, Illinois, 60637

  • Arthritis Associates of Colorado Springs

    Colorado Springs, Colorado, 80910

  • Ohio State University

    Columbus, Ohio, 43210

  • Osteoporosis and Clinical Trials Center

    Cumberland, Maryland, 21502

  • University of Texas - Southwestern Medical Center

    Dallas, Texas, 75390-8884

  • STAT Research, Inc.

    Dayton, Ohio, 45408

  • Stafford Medical Associates, PA

    Dover, New Hampshire, 03820

  • Altoona Center for Clinical Research

    Duncanville, Pennsylvania, 16635

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905

  • Physicians East, PA

    Greenville, North Carolina, 27834

  • Palmetto Clinical Trial at Piedmont Arthritis Clinic

    Greenville, South Carolina, 29601

  • Osteoporosis & Clinical Trials Center

    Hagerstown, Maryland, 21740

  • The Rheumatic Disease Clinical Research Center

    Houston, Texas, 77004

  • Accurate Clinical Research

    Houston, Texas, 77034

  • Houston Institute for Clinical Research

    Houston, Texas, 77074

  • Talbert Medical Group

    Huntington Beach, California, 92646

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • North Shore-LIJ Health System/Rheumatology and Allergy Clinic

    Lake Success, New York, 11042

  • Fiechtner Research, Inc.

    Lansing, Michigan, 48910

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

    Long Beach, California, 90806

  • University of Southern California

    Los Angeles, California, 90033

  • Wallace Rheumatic Study Center

    Los Angeles, California, 90048

  • UCLA Rheumatology

    Los Angeles, California, 90095

  • Kentuckiana Center for Better Bone and Joint Health

    Louisville, Kentucky, 40202

  • Feinstein Institute

    Manhasset, New York, 11030

  • University of Miami-Division of Rheumatology and Immunology

    Miami, Florida, 03136

  • Medical Specialists Clinical Research

    Munster, Indiana, 46321

  • Hopital for Joint Diseases

    New York, New York, 10003

  • Hospital for Special Surgery

    New York, New York, 10021

  • Oklahoma Medical Research Center

    Oklahoma City, Oklahoma, 74104

  • Gundersen Clinic, Ltd.

    Onalaska, Wisconsin, 54650

  • Rheumatology Associates of Central Florida

    Orlando, Florida, 32806

  • Arizona Arthritis and Rheumatology Research, PPLC

    Paradise Valley, Arizona, 85253

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • AAIR Research Center

    Rochester, New York, 14618

  • Rheumatology Clinic

    Salt Lake City, Utah, 84124

  • Arthritis Center of South Texas

    San Antonio, Texas, 78232

  • Arthritis Care Center, Inc.

    San Jose, California, 95126

  • The Seattle Arthritis Clinic

    Seattle, Washington, 98133

  • Rheumatology Associates

    Smithtown, New York, 11787

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Texas Research Center

    Sugar Land, Texas, 77479

  • Southwest Florida Clinical Research Center

    Tampa, Florida, 33609

  • Tampa Medical Group, P.A.

    Tampa, Florida, 33614

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • The University of Arizona Arthritis Center

    Tucson, Arizona, 85724

  • Oklahoma Center For Arthritis Therapy & Research

    Tulsa, Oklahoma, 74104

  • Inland Rheumatic Disease Specialties

    Upland, California, 91786

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wake Forest University Health Services

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany13 sites

  • Kerckhoff-Klink Bad Nauheim

    Bad Nauheim, 61231

  • Schlossparkklinik

    Berlin, 10589

  • Charite

    Berlin, 13353

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

    Düsseldorf, 40225

  • FA Universitat Erlangen Nurnberg

    Erlangen, 91054

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590

  • Medizinische Universitatsklinik

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Friedrich Schiller Universitat

    Jena, 07740

  • Universitatsklinik Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • Universitatsklinik Mainz

    Mainz, 55131

  • Universitatsklinikum Tubingen

    Tübingen, 72076

Other trials in Germany

Israel8 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • B'nai-Zion Medical Center

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 31096

  • Carmel Medical Center

    Haifa, 34362

  • Beilinson Hospital, Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel-Aviv Saurasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Italy8 sites

  • A. O. Ospedaliera-Universitaria Arcispedale

    Ferrara, 44100

  • A.O. Ospedale San Carlo Borromeo

    Milan, 20153

  • Policlinico di Modena

    Modena, 41100

  • Policlinico Universitario of Padova

    Padova, 35128

  • A.O. San Camillo

    Rome, 00152

  • Policlinico Umberto 1

    Rome, 00161

  • U.O. di reumatologia Presidio Ospedaliero di Scafati

    Scafati, 84018

  • Azienda Ospedaliero University-Santa Maria della Misericordia

    Udine, 33100

Other trials in Italy

Mexico7 sites

  • Hospital Civil de Guadalajara "Fray Antonio Alcalde"

    Guadalajara, 45235

  • Instituto Jalisciense de Investigacion Clinica

    Jalisco, 44100

  • Hospital General de México

    Mexico City, 06726

  • Hospital Regional 1o de Octubre - ISSSTE

    Mexico City, 07760

  • Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin

    Mexico City, 14000

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

    San Luis Potosí City, 78240

  • Instituto de Seguridad Social del Estado de Mexico y Municipios

    Toluca, 52170

Other trials in Mexico

Poland6 sites

  • Szpital Uniwerytecki nr Zim. dr. Jana Biziela

    Bydgoszcz, 85-168

  • Szpital Specjalistyczny Sw. Lukasza

    Gmina Końskie, 26-200

  • Malopolskie Centrum Medyczne

    Krakow, 30-510

  • Gabinety Profesorow Osrodek Baden Klinicznych

    Lublin, 20-022

  • Klinika Reumatologii im Prof. Eleonory Reicher

    Warsaw, 02-637

  • Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych

    Wroclaw, 50-556

Other trials in Poland

Spain6 sites

  • Hospital La Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial Barcelona

    Barcelona, 08036

  • Hospital Universitario San Cecilio

    Granada, 18012

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de SAS - Carlos Haya

    Málaga, 29010

  • Hospital Son Dureta

    Mallorca, 07014

Other trials in Spain

France5 sites

  • CHU Hospital de Bicetre

    Le Kremlin-Bicêtre, 94270

  • Hospital Huriez

    Lille, 59037

  • Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique

    Stasbourg, 67091

  • Hospital FOCH

    Suresnes, 92151

  • Centre Hospitalier Universitarie (CHU) - PURPAA

    Toulouse, 31059

Other trials in France

Czechia4 sites

  • University Hospital Brno

    Brno, 62500

  • University Hospital Hradec Kralove

    Hradec Králové, 50005

  • University Hospital Olomouc

    Olomouc, 77520

  • Institute of Rheumatology

    Prague, 12850

Other trials in Czechia

Netherlands4 sites

  • Leiden University Medical Center

    Leiden, 2333ZA

  • University Medical Center Maastricht

    Maastricht, 6229HX

  • Erasmus Medical Center

    Rotterdam, 3015CE

  • Ikazia Ziekenhuis

    Rotterdam, 3083AN

Other trials in Netherlands

Belgium3 sites

  • Cliniques Universitaires

    Brussels, 1200

  • University Hospital

    Leuven, 3000

  • CHU Sart Tilman

    Liège, 4000

Other trials in Belgium

Canada3 sites

  • McGill University Health Centre, Montreal General Hospital

    Montreal, H3G 1A4

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Centre for Prognosis Studies in Rheaumatic Diseases

    Toronto, Ontario, M5T2S8

Other trials in Canada

Austria2 sites

  • Universitatsklinik fur innere Medizin

    Graz, 8036

  • Rheumazentrum Favoriten

    Vienna, 1100

Other trials in Austria

Puerto Rico2 sites

  • Ponce School of Medicine

    Ponce, 00716

  • University of Puerto Rico Medical Center

    Rio Piedras, 00935

Other trials in Puerto Rico

Romania2 sites

  • Spitalul Clinic "Sf Maria"

    Bucharest, 011170

  • Spitalul Clinic Colentina

    Bucharest, 020125

Other trials in Romania

Sweden2 sites

  • Sahlgrensja University Hospital

    Gothenburg, 41345

  • Karolinska Universitetssjukhuset

    Stockholm, 17176

Other trials in Sweden

United Kingdom2 sites

  • St. Thomas Hospital

    London, SE17EH

  • Freeman Hospital

    Newcastle upon Tyne, NE77DN

Other trials in United Kingdom

Costa Rica1 site

  • Hospital Clinica Biblica

    San José

Other trials in Costa Rica

Slovakia1 site

  • Narodny Ustav Reumatickych Chorob

    Piešťany, 92112

Other trials in Slovakia

About this study

Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

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.

Being tested
Placebo, Belimumab 1 mg/kg, Belimumab 10 mg/kg
Keywords
Antibodies, Autoimmune Diseases, Systemic Lupus Erythematosus, SLE, Belimumab, Lupus
Medical subject headings
Lupus Erythematosus, Systemic, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • Belimumab 1 mg/kgDrug

    Also called LymphoStat-B™, belimumab

    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/kgDrug

    Also called LymphoStat-B™, belimumab

    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.

Study groups in NCT00410384
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo
Belimumab 1 mg/kgExperimentalBelimumab 1 mg/kg
Receives: Drug: Belimumab 1 mg/kg
Belimumab 10 mg/kgExperimentalBelimumab 10 mg/kg
Receives: Drug: Belimumab 10 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SLE Responder Index (SRI) Response Rate at Week 52

    Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.

    SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

    Measured: Baseline, 52 Weeks

Secondary outcomes (5)

  1. SRI Response Rate at Week 76

    Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.

    SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

    Measured: Baseline, 76 Weeks

  2. Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.

    Measured: Baseline, 52 Weeks

  3. Mean Change in Physician's Global Assessment (PGA) at Week 24.

    The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.

    Measured: Baseline, 24 Weeks

  4. Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.

    The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.

    Measured: Baseline, 24 Weeks

  5. Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52

    Measured: Baseline, Weeks 40-52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionSep 2009
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
819 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00410384
Sponsor's protocol ID
HGS1006-C1056
Other IDs
BLISS-76, 110751
Acronym
BLISS-76
Status last verified
Dec 2016
First submitted
8 Dec 2006
Last updated
1 Feb 2017
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 40256631

  • Parodis I, Lindblom J, Levy RA, Zen M, Cetrez N, Gomez A, Oon S, Henning C, Khamashta M, Quasny HA, Chauhan D, Askanase A, van Vollenhoven R, Nikpour M. Attainment of remission and low disease activity after treatment with belimumab in patients with systemic lupus erythematosus: a post-hoc analysis of pooled data from five randomised clinical trials. Lancet Rheumatol. 2024 Nov;6(11):e751-e761. doi: 10.1016/S2665-9913(24)00162-0. Epub 2024 Aug 26.

    PubMed 39208825

  • 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.

    PubMed 39115551

  • 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.

    PubMed 38775637

  • Rendas-Baum R, Chen WH, Gairy K, Anderson S, Henning C, Hammer A, Kosinski M. SF-36v2 and FACIT-Fatigue quality of life improvements with organ-specific SELENA-SLEDAI response and belimumab treatment in patients with systemic lupus erythematosus. Lupus Sci Med. 2024 May 8;11(1):e001118. doi: 10.1136/lupus-2023-001118.

    PubMed 38724182

  • Jesus D, Henriques C, Matos A, Doria A, Ines LS. Systemic Lupus Erythematosus Disease Activity Score Remission and Low Disease Activity States Discriminate Drug From Placebo and Better Health-Related Quality of Life. Arthritis Care Res (Hoboken). 2024 Jun;76(6):788-795. doi: 10.1002/acr.25305. Epub 2024 Feb 29.

    PubMed 38258369

  • 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.

    PubMed 38216728

  • 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.

    PubMed 37228028

  • 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.

    PubMed 35302581

  • 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.

    PubMed 34741731

  • 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.

    PubMed 34628605

  • 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.

    PubMed 34531304

  • 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.

    PubMed 33830377

  • 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.

    PubMed 33568389

  • 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.

    PubMed 32918459

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belimumab 1 mg/kg and Belimumab 10 mg/kg in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc. at 146 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Germany, Israel, Italy, Mexico and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SLE Responder Index (SRI) Response Rate at Week 52 (time frame: Baseline, 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00410384, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.

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