Systemic Lupus ErythematosusPhase 2NCT00583362

A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

A Phase 2 study testing Belimumab in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc., a GSK Company at 57 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

This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment. 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 298 participants
Where: 57 sitesin 2 countries
Study dates: 4 May 2005to 23 Feb 2016
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Primary Inclusion Criteria

Have completed the LBSL02 trial and achieved a satisfactory response.

Primary Exclusion Criteria

Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.
Used any of the following prohibited medications during their participation in LBSL02:

Other investigational agents.
Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™).
Intravenous cyclophosphamide.
Corticosteroids >100 mg/day prednisone equivalent for reasons other than severe SLE flare.

Trial locations and contacts

57 sites in 2 countries.

Country

City, postcode or hospital

57 sites in 2 countries

United States56 sites

GSK Investigational Site
Albany, New York, 12206
GSK Investigational Site
Ann Arbor, Michigan, 48109-5542
GSK Investigational Site
Arlington, Virginia, 22205-3606
GSK Investigational Site
Atlanta, Georgia, 30303
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Baltimore, Maryland, 21287
GSK Investigational Site
Baton Rouge, Louisiana, 70809
GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Boise, Idaho, 83704
GSK Investigational Site
Boston, Massachusetts, 02111
GSK Investigational Site
Brooklyn, New York, 11203
GSK Investigational Site
Charlotte, North Carolina, 28210
GSK Investigational Site
Chicago, Illinois, 60611
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Colorado Springs, Colorado, 80920
GSK Investigational Site
Concord, New Hampshire, 03301
GSK Investigational Site
Cumberland, Maryland, 21502
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Dallas, Texas, 75390-8550
GSK Investigational Site
Dayton, Ohio, 45417
GSK Investigational Site
Dover, New Hampshire, 03820
GSK Investigational Site
Great Neck, New York, 11021
GSK Investigational Site
Houston, Texas, 77074
GSK Investigational Site
Idaho Falls, Idaho, 83401
GSK Investigational Site
Kansas City, Kansas, 66160
GSK Investigational Site
La Jolla, California, 92037
GSK Investigational Site
Lincoln, Nebraska, 68516
GSK Investigational Site
Los Angeles, California, 90033
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Manhasset, New York, 11030
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
Munster, Indiana, 46321
GSK Investigational Site
New Orleans, Louisiana, 70121
GSK Investigational Site
Oklahoma City, Oklahoma, 73103
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
Onalaska, Wisconsin, 54650
GSK Investigational Site
Orlando, Florida, 32806-6264
GSK Investigational Site
Pittsburgh, Pennsylvania, 15217
GSK Investigational Site
Rochester, New York, 14618
GSK Investigational Site
Sacramento, California, 95817
GSK Investigational Site
San Jose, California, 95124
GSK Investigational Site
Scottsdale, Arizona, 85260
GSK Investigational Site
Seattle, Washington, 98133
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
St Louis, Missouri, 63110
GSK Investigational Site
Sugar Land, Texas, 77479
GSK Investigational Site
Tampa, Florida, 33614
GSK Investigational Site
Tucson, Arizona, 85724
GSK Investigational Site
Tulsa, Oklahoma, 74104
GSK Investigational Site
Upland, California, 91786
GSK Investigational Site
Washington D.C., District of Columbia, 20010
GSK Investigational Site
Wheaton, Maryland, 20902
GSK Investigational Site
Willow Grove, Pennsylvania, 19090
GSK Investigational Site
Winston-Salem, North Carolina, 27157

Other trials in United States

Canada1 site

GSK Investigational Site
Montreal, Quebec, H3G 1A4

Other trials in Canada

About this study

Official title: A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02

This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.

Read the detailed description

The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.

Conditions: Systemic Lupus Erythematosus
Being tested: Belimumab
Keywords: SLE, Lupus
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.

BelimumabBiological
Also called LymphoStat-B™, HGS1006, BENLYSTA
Belimumab 10mg/kg IV over one hour every 28 days

Study groups in NCT00583362
Study group	Role	What they receive
Belimumab 10 mg/kg	Experimental	Belimumab 10 mg/kg IV over one hour every 28 days. Receives: Biological: Belimumab

What is being measured

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

Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example [eg], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and is medically important.
Measured: Approximately up to 13 years
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent AEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).
Measured: Approximately up to 13 years
SAE Rates by System Organ Class (SOC) During the Study
SAE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent SAEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pretreatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).
Measured: Approximately up to 13 years
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 40, and 48 during Year 1 to 8; Week 8, 16, 24, and 40 during Year 9; Week 24 and 40 during Year 10; Week 48 during Year 11; Week 32 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years
Change From Baseline in Erythrocytes at the Indicated Time Points
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years
Change From Baseline in Hematocrit at the Indicated Time Points
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years
Change From Baseline in Hemoglobin at the Indicated Time Points
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years
Change From Baseline in Albumin and Protein at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in creatinine, urate, and bilirubin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years
Change From Baseline in BUN/Creatinine at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in ALT, AP, AST, GGT and LD are summarized. Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years

Secondary outcomes (8)

Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
SRI response was assessed at Week 16, 32, and 48 during Year 1 to 12 and Week 16 and 32 during Year 13. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. SRI response is defined as:>=4 point reduction from the Baseline in safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the Baseline) in Physician's Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the Baseline at the time of assessment.
Measured: Approximately up to 13 years
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Anti-double stranded DNA levels in participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.
Measured: Approximately up to 13 years
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Anti-double stranded DNA levels for participants positive at Baseline were assessed at Baseline, Week 16, 32, and 48 during Year 1 to 11, Week 16 and 32 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.
Measured: Approximately up to 13 years
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
Complement C3 and C4 levels were assessed in participants low at Baseline at Baseline, Week 16, 32, and 48 during Year 1 to 12, Week 16 and 32 during Year 13, and Exit visit. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Daily prednisone dose reduction was assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study.
Measured: Approximately up to 13 years
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study.
Measured: Approximately up to 13 years
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Serum immunoglobulin G values were assessed at Baseline, Week 8, 16, 24, 32, 40, and 48 during Year 1 to 12 and Week 8, 16, 24, 32, and 40 during Year 13, Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. For Year 1, Baseline included Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with belimumab in the parent study. Percent change from Baseline is defined as the percentage of the difference between the post-dose post-Baseline visit value and the Baseline value.
Measured: Baseline and approximately up to 13 years

Timeline

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

4 May 200523 Feb 2016

First posted31 Dec 2007 (estimated)
Study start4 May 2005
Primary completion23 Feb 2016
Study completion23 Feb 2016

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 (2)Papers the sponsor has linked to this study.
Other trials for Systemic Lupus ErythematosusStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 298 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00583362
Sponsor's protocol ID: 112626
Status last verified: Jun 2019
First submitted: 20 Dec 2007
Last updated: 23 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

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
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

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 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02
ClinicalTrials.gov ID: NCT00583362
Acronym / sponsor ID: 112626
Conditions: Systemic Lupus Erythematosus
Keywords: SLE, Lupus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 298 participants (actual)
Lead sponsor: Human Genome Sciences Inc., a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: 4 May 2005 (actual)
Primary completion: 23 Feb 2016 (actual)
Study completion: 23 Feb 2016 (actual)
First posted: 31 Dec 2007 (estimated)
Results: Posted 28 Apr 2017

Clinical summary

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

This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Belimumab 10 mg/kg	Experimental	Biological: BelimumabBelimumab 10 mg/kg IV over one hour every 28 days.

Who may qualify

Ages: 18 years and older
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
BelimumabAlso: LymphoStat-B™, HGS1006, BENLYSTABelimumab 10mg/kg IV over one hour every 28 days	Biological	Belimumab 10 mg/kg

Primary outcome

Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
Time frame: Approximately up to 13 years
An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example [eg], increase in frequency or severity) of pre-existing conditions. An SAE is defined as an AE resulting in any of the following outcomes: death, is life threatening (that is, an immediate threat to life), inpatient hospitalization, prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and is medically important.
Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
Time frame: Approximately up to 13 years
AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent AEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).
SAE Rates by System Organ Class (SOC) During the Study
Time frame: Approximately up to 13 years
SAE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatmentemergent SAEs are summarized. The Baseline is defined as the last available value prior to belimumab start date, for participants treated with placebo in the parent study and last pretreatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate=100* number of events divided by participant years. Participant years were calculated as sum across all participants ([last visit of interval day minus first visit of interval day plus 1] divided by 365).
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 40, and 48 during Year 1 to 8; Week 8, 16, 24, and 40 during Year 9; Week 24 and 40 during Year 10; Week 48 during Year 11; Week 32 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils segmented and platelets is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Change From Baseline in Erythrocytes at the Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Change From Baseline in Hematocrit at the Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Change From Baseline in Hemoglobin at the Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Hematology parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Change From Baseline in Albumin and Protein at the Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in creatinine, urate, and bilirubin is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value.
Change From Baseline in BUN/Creatinine at the Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Clinical chemistry parameters were assessed at Baseline, Week 8, 16, 24, 32, 40 and 48 during Year 1 to 12; Week 8, 16, 24, 32, and 40 during Year 13; Exit visit and at follow-up (up to 8 weeks and 24 weeks post last infusion). Change from Baseline in ALT, AP, AST, GGT and LD are summarized. Baseline is defined as the Extension Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.

8 secondary outcomes

Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
Time frame: Approximately up to 13 years
Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
Time frame: Approximately up to 13 years
Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
Time frame: Approximately up to 13 years
Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
Time frame: Baseline and approximately up to 13 years
Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
Time frame: Approximately up to 13 years
Absolute Serum Immunoglobulin G Values at Indicated Time Points
Time frame: Approximately up to 13 years
Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
Time frame: Baseline and approximately up to 13 years

Results and safety

Results posted to the registry on 28 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Belimumab 10 mg/kg IV	298	96

Primary outcome: Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)

Time frame: Approximately up to 13 years. Number. Unit: Participants

Measure	Belimumab 10 mg/kg IV n = 296
AE, Any time post baseline, n=296	294
AE, Year 0-1, n=296	291
AE, Year 1-2, n=294	283
AE, Year 2-3, n=276	260
AE, Year 3-4, n=250	239
AE, Year 4-5, n=223	203
AE, Year 5-6, n=209	190
AE, Year 6-7, n=192	182

Population analysed: MITT Population. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.

Primary outcome: Adverse Event (AE) Rates by System Organ Class (SOC) During the Study

Time frame: Approximately up to 13 years. Number. Unit: Events per 100 participant years

Measure	Belimumab 10 mg/kg IV n = 296
Infections and infestations	285
Musculoskeletal and connective tissue disorders	276
Gastrointestinal disorders	257
Skin and subcutaneous tissue disorders	256
General disorders, administration site conditions	247
Nervous system disorders	244
Respiratory, thoracic and mediastinal disorders	241
Investigations	227

Population analysed: MITT Population

Primary outcome: SAE Rates by System Organ Class (SOC) During the Study

Time frame: Approximately up to 13 years. Number. Unit: Events per 100 participant years

Measure	Belimumab 10 mg/kg IV n = 296
Infections and infestations	69
Musculoskeletal and connective tissue disorders	44
Gastrointestinal disorders	38
Nervous system disorders	35
General disorders, administration site conditions	31
Injury, poisoning and procedural complications	29
Respiratory, thoracic and mediastinal disorders	25
Cardiac disorders	23

Population analysed: MITT population

Primary outcome: Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points

Time frame: Baseline and approximately up to 13 years. Mean (Standard Deviation). Unit: Seconds

Measure	Belimumab 10 mg/kg IV n = 296
APTT, Year 1, Week 8, n=274	0.3 (12.60)
APTT, Year 1, Week 16, n=276	-1.3 (7.46)
APTT, Year 1, Week 24, n=222	-1.6 (13.61)
APTT, Year 1, Week 32, n=221	-1.9 (7.24)
APTT, Year 1, Week 40, n=219	-1.6 (7.00)
APTT, Year 1, Week 48, n=218	-1.0 (7.29)
APTT, Year 2, Week 8, n=220	-0.3 (6.73)
APTT, Year 2, Week 16, n=214	-0.2 (8.79)

Population analysed: MITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 until follow-up (approximately up to 13 years).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Belimumab 10 mg/kg IV	182 of 296 (61.5%)	293 of 296 (99%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 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.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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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 (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

57 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 in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc., a GSK Company at 57 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 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. 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 Apr 2017). 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?

Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) (time frame: Approximately up to 13 years). The study lists 13 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 NCT00583362, which also lists 2 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 23 Jul 2019.