Lupus Erythematosus, SystemicPhase 2NCT00071487

Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 2 study testing Belimumab 1 mg/kg, Belimumab 4 mg/kg and Belimumab 10 mg/kg in people with Lupus Erythematosus, Systemic, run by Human Genome Sciences Inc. at 62 sites in 2 countries.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Lupus Erythematosus, Systemic
What is being tested?: Belimumab 1 mg/kg, Belimumab 4 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: 449 participants
Where: 62 sitesin 2 countries
Study dates: Oct 2003to Jun 2006
Phase: Phase 2
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Primary Inclusion Criteria

Clinical diagnosis of SLE
"Active" SLE disease
On a stable SLE treatment regimen
History of measurable autoantibodies

Primary Exclusion Criteria

Received a non-FDA approved investigational agent within last 28 days
Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days
Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 90 days
Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days
History of renal transplant
History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days
History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency
Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C

Trial locations and contacts

62 sites in 2 countries.

Country

City, postcode or hospital

62 sites in 2 countries

United States60 sites

The Center for Rheumatology
Albany, New York, 12206
The University of Michigan Health System
Ann Arbor, Michigan, 48109-0358
Arthritis Clinic of Northern Virginia, P.C.
Arlington, Virginia, 22205
Emory University
Atlanta, Georgia, 30303
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70809
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0006
Radiant Research Boise
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, 27599-7280
Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, 28210
Northwestern University Medical School
Chicago, Illinois, 60611
Rheumatology Associates
Chicago, Illinois, 60612
Arthritis Associates & Osteoporosis Center Of Colorado Springs
Colorado Springs, Colorado, 80910
Arthritis and Osteoporosis Center
Concord, New Hampshire, 03301
The Osteoporosis and Arthritis Clinical Trial Center
Cumberland, Maryland, 21502
Research Associates of North Texas
Dallas, Texas, 75246
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8884
Stat Research Inc.
Dayton, Ohio, 45402
Strafford Medical Associates, P.A.
Dover, New Hampshire, 03820
Edmonds Rheumatology Associates
Edmonds, Washington, 98026-8047
Institute of Arthritis and Research
Idaho Falls, Idaho, 83404
Gundersen Clinic, Ltd.
La Crosse, Wisconsin, 54610
Scripps Clinic
La Jolla, California, 92037
Arthritis Center of Nebraska
Lincoln, Nebraska, 68506
University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Kentuckiana Center for Better Bone and Joint Health
Louisville, Kentucky, 40202
North Shore University Hospital
Manhasset, New York, 11030
The Medical College of Wisconsin , Inc
Milwaukee, Wisconsin, 53226
Medical Specialists
Munster, Indiana, 46321
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Arthritis and Rheumatic Disease Clinic
Ogden, Utah, 84044
Bone and Joint Hospital
Oklahoma City, Oklahoma, 73103
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Rheumatology Associates of Central Florida
Orlando, Florida, 32806
Stanford University School of Medicine
Palo Alto, California, 94304
Arizona Arthritis Research
Paradise Valley, Arizona, 85253
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
University of Pittsburgh School of Medicine & ASPH
Pittsburgh, Pennsylvania, 15261
Boling Clinical Trials
Rancho Cucamonga, California, 91730
Aair Research
Rochester, New York, 14618
UCDMC
Sacramento, California, 95817-1418
Arthritis Care Center, Inc.
San Jose, California, 95126-1650
Physicians Research Options, LC
Sandy City, Utah, 84070
Arthritis Northwest Rheumatology
Spokane, Washington, 99204
Washington University in St. Louis
St Louis, Missouri, 63110
Texas Research Center
Sugar Land, Texas, 77479
Tampa Medical Group, P.A.
Tampa, Florida, 33614
Jacobi Medical Center
The Bronx, New York, 10461
University of Arizona
Tucson, Arizona, 85724
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma, 74114
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Marshfield Medical Research Foundation
Wausau, Wisconsin, 54401
Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157

Other trials in United States

Canada2 sites

McGill University Health Center
Montreal, Quebec, H3G 1A4
Toronto Western Hospital
Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.

Read the detailed description

The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active SLE disease. Patients were randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7 versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy for SLE). All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 52 weeks. Patients completing the 52-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.

Conditions: Lupus Erythematosus, Systemic
Being tested: Placebo, Belimumab 1 mg/kg, Belimumab 4 mg/kg, Belimumab 10 mg/kg
Keywords: SLE
Medical subject headings: Lupus Erythematosus, Systemic

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 (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
Belimumab 1 mg/kgDrug
Also called LymphoStat-B®, BENLYSTA®
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 4 mg/kgDrug
Also called LymphoStat-B®, BENLYSTA®
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 10 mg/kgDrug
Also called LymphoStat-B®, BENLYSTA®
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.

Study groups in NCT00071487
Study group	Role	What they receive
Placebo plus SOC	Placebo comparator	Not described Receives: Drug: Placebo
Belimumab 1 mg/kg plus SOC	Experimental	Not described Receives: Drug: Belimumab 1 mg/kg
Belimumab 4 mg/kg plus SOC	Experimental	Not described Receives: Drug: Belimumab 4 mg/kg
Belimumab 10 mg/kg plus SOC	Experimental	Not described Receives: Drug: Belimumab 10 mg/kg

What is being measured

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

Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.
Measured: Baseline, 24 weeks
Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)
The SLE Flare Index categorized SLE flare as "mild or moderate" or "severe" based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).
Measured: 0 to 52 weeks

Secondary outcomes (6)

Percentage Change From Baseline in SELENA SLEDAI Score at Week 52
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare
Measured: Baseline, 52 weeks
Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.
Measured: Baseline and every 4 to 8 weeks through Week 52
Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52
The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.
Measured: Baseline, 52 weeks
Area Under the Curve (AUC) of BILAG Score at Week 52
The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score.
Measured: Baseline and every 4 to 8 weeks through Week 52
Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks
SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.
Measured: 0 to 52 weeks
Percentage of Patients With a Reduction in Prednisone Dose
Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.
Measured: Baseline, weeks 40 to 52

Timeline

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

Oct 2003Jun 2006

First posted28 Oct 2003 (estimated)
Study startOct 2003
Primary completionAug 2005
Study completionJun 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 449 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00071487
Sponsor's protocol ID: LBSL02
Status last verified: Aug 2013
First submitted: 24 Oct 2003
Last updated: 7 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, Petri MA, Ginzler EM, Chatham WW, McCune WJ, Fernandez V, Chevrier MR, Zhong ZJ, Freimuth WW. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009 Sep 15;61(9):1168-78. doi: 10.1002/art.24699.
PubMed 19714604
Furie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, Chatham WW, Strand V, Weinstein A, Chevrier MR, Zhong ZJ, Freimuth WW. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009 Sep 15;61(9):1143-51. doi: 10.1002/art.24698.
PubMed 19714615
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
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
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PubMed 33687069
Ginzler EM, Wallace DJ, Merrill JT, Furie RA, Stohl W, Chatham WW, Weinstein A, McKay JD, McCune WJ, Zhong ZJ, Freimuth WW, Petri MA; LBSL02/99 Study Group. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014 Feb;41(2):300-9. doi: 10.3899/jrheum.121368. Epub 2013 Nov 1.
PubMed 24187095
Struemper H, Chen C, Cai W. Population pharmacokinetics of belimumab following intravenous administration in patients with systemic lupus erythematosus. J Clin Pharmacol. 2013 Jul;53(7):711-20. doi: 10.1002/jcph.104. Epub 2013 May 16.
PubMed 23681782
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.
PubMed 23213069
Merrill JT, Ginzler EM, Wallace DJ, McKay JD, Lisse JR, Aranow C, Wellborne FR, Burnette M, Condemi J, Zhong ZJ, Pineda L, Klein J, Freimuth WW; LBSL02/99 Study Group. Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Oct;64(10):3364-73. doi: 10.1002/art.34564.
PubMed 22674457
Jacobi AM, Huang W, Wang T, Freimuth W, Sanz I, Furie R, Mackay M, Aranow C, Diamond B, Davidson A. Effect of long-term belimumab treatment on B cells in systemic lupus erythematosus: extension of a phase II, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2010 Jan;62(1):201-10. doi: 10.1002/art.27189.
PubMed 20039404

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT00071487
Acronym / sponsor ID: LBSL02
Conditions: Lupus Erythematosus, Systemic
Keywords: SLE
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 449 participants (actual)
Lead sponsor: Human Genome Sciences Inc.Industry (pharma, biotech, devices)
Study start: Oct 2003
Primary completion: Aug 2005 (actual)
Study completion: Jun 2006 (actual)
First posted: 28 Oct 2003 (estimated)
Results: Posted 28 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo plus SOC	Placebo comparator	Drug: Placebo
Belimumab 1 mg/kg plus SOC	Experimental	Drug: Belimumab 1 mg/kg
Belimumab 4 mg/kg plus SOC	Experimental	Drug: Belimumab 4 mg/kg
Belimumab 10 mg/kg plus SOC	Experimental	Drug: Belimumab 10 mg/kg

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.	Drug	Placebo plus SOC
Belimumab 1 mg/kgAlso: LymphoStat-B®, BENLYSTA®Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.	Drug	Belimumab 1 mg/kg plus SOC
Belimumab 4 mg/kgAlso: LymphoStat-B®, BENLYSTA®Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.	Drug	Belimumab 4 mg/kg plus SOC
Belimumab 10 mg/kgAlso: LymphoStat-B®, BENLYSTA®Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.	Drug	Belimumab 10 mg/kg plus SOC

Primary outcome

Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.
Time frame: Baseline, 24 weeks
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.
Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)
Time frame: 0 to 52 weeks
The SLE Flare Index categorized SLE flare as "mild or moderate" or "severe" based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).

6 secondary outcomes

Percentage Change From Baseline in SELENA SLEDAI Score at Week 52
Time frame: Baseline, 52 weeks
Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52
Time frame: Baseline and every 4 to 8 weeks through Week 52
Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52
Time frame: Baseline, 52 weeks
Area Under the Curve (AUC) of BILAG Score at Week 52
Time frame: Baseline and every 4 to 8 weeks through Week 52
Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks
Time frame: 0 to 52 weeks
Percentage of Patients With a Reduction in Prednisone Dose
Time frame: Baseline, weeks 40 to 52

Results and safety

Results posted to the registry on 28 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Plus SOC	113	93
Belimumab 1 mg/kg Plus SOC	114	87
Belimumab 4 mg/kg Plus SOC	111	94
Belimumab 10 mg/kg Plus SOC	111	90

Primary outcome: Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.

Time frame: Baseline, 24 weeks. Mean (Standard Error). Unit: percent change

Measure	Placebo Plus SOC n = 113	Belimumab 1 mg/kg Plus SOC n = 114	Belimumab 4 mg/kg Plus SOC n = 111	Belimumab 10 mg/kg Plus SOC n = 111
Value	-17.2 (5.1)	-23.3 (4.4)	-11.3 (5.4)	-23.7 (4.2)

Placebo Plus SOC vs Belimumab 1 mg/kg Plus SOC: Mean Difference (Final Values): -6.1 (95% CI -19.4 to 7.2), p = 0.3677, t-test, 2 sided
Placebo Plus SOC vs Belimumab 4 mg/kg Plus SOC: Mean Difference (Final Values): 5.9 (95% CI -8.7 to 20.6), p = 0.4244, t-test, 2 sided
Placebo Plus SOC vs Belimumab 10 mg/kg Plus SOC: Mean Difference (Final Values): -6.5 (95% CI -19.6 to 6.6), p = 0.3296, t-test, 2 sided

Population analysed: Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.

Primary outcome: Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)

Time frame: 0 to 52 weeks. Median (Inter-Quartile Range). Unit: days

Measure	Placebo Plus SOC n = 113	Belimumab 1 mg/kg Plus SOC n = 114	Belimumab 4 mg/kg Plus SOC n = 111	Belimumab 10 mg/kg Plus SOC n = 111
Value	83 (42 to 140)	68 (39 to 146)	61 (29 to 147)	70 (29 to 154)

Placebo Plus SOC vs Belimumab 1 mg/kg Plus SOC: p = 0.6423, Log Rank
Placebo Plus SOC vs Belimumab 4 mg/kg Plus SOC: p = 0.8536, Log Rank
Placebo Plus SOC vs Belimumab 10 mg/kg Plus SOC: p = 0.9705, Log Rank

Population analysed: Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 84 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Plus SOC	22 of 113 (19.5%)	103 of 113 (91.2%)	Not reported
Belimumab 1 mg/kg Plus SOC	21 of 114 (18.4%)	107 of 114 (93.9%)	Not reported
Belimumab 4 mg/kg Plus SOC	15 of 111 (13.5%)	100 of 111 (90.1%)	Not reported
Belimumab 10 mg/kg Plus SOC	18 of 111 (16.2%)	105 of 111 (94.6%)	Not reported
Open-label Extension Period: All Active	33 of 345 (9.6%)	312 of 345 (90.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19714604Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, Petri MA, Ginzler EM, Chatham WW, McCune WJ, Fernandez V, Chevrier MR, Zhong ZJ, Freimuth WW. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009 Sep 15;61(9):1168-78. doi: 10.1002/art.24699.
Results publication: PubMed 19714615Furie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, Chatham WW, Strand V, Weinstein A, Chevrier MR, Zhong ZJ, Freimuth WW. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009 Sep 15;61(9):1143-51. doi: 10.1002/art.24698.
Derived from this study: PubMed 38775637Arends 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.
Derived from this study: PubMed 34741731Gupta 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.
Derived from this study: PubMed 34628605Zhou 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.
Derived from this study: PubMed 34531304Brunner 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.
Derived from this study: PubMed 33687069Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Derived from this study: PubMed 24187095Ginzler EM, Wallace DJ, Merrill JT, Furie RA, Stohl W, Chatham WW, Weinstein A, McKay JD, McCune WJ, Zhong ZJ, Freimuth WW, Petri MA; LBSL02/99 Study Group. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014 Feb;41(2):300-9. doi: 10.3899/jrheum.121368. Epub 2013 Nov 1.
Derived from this study: PubMed 23681782Struemper H, Chen C, Cai W. Population pharmacokinetics of belimumab following intravenous administration in patients with systemic lupus erythematosus. J Clin Pharmacol. 2013 Jul;53(7):711-20. doi: 10.1002/jcph.104. Epub 2013 May 16.
Derived from this study: PubMed 23213069Wallace 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.
Derived from this study: PubMed 22674457Merrill JT, Ginzler EM, Wallace DJ, McKay JD, Lisse JR, Aranow C, Wellborne FR, Burnette M, Condemi J, Zhong ZJ, Pineda L, Klein J, Freimuth WW; LBSL02/99 Study Group. Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Oct;64(10):3364-73. doi: 10.1002/art.34564.
Derived from this study: PubMed 20039404Jacobi AM, Huang W, Wang T, Freimuth W, Sanz I, Furie R, Mackay M, Aranow C, Diamond B, Davidson A. Effect of long-term belimumab treatment on B cells in systemic lupus erythematosus: extension of a phase II, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2010 Jan;62(1):201-10. doi: 10.1002/art.27189.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

62 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belimumab 1 mg/kg, Belimumab 4 mg/kg and Belimumab 10 mg/kg in people with Lupus Erythematosus, Systemic, run by Human Genome Sciences Inc. at 62 sites in 2 countries.

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

Who may be eligible to take part?

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 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 28 Aug 2012). 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?

Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. (time frame: Baseline, 24 weeks). The study lists 2 primary outcomes in all. 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 NCT00071487, which also lists 12 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 7 Aug 2013.