Systemic Lupus ErythematosusPhase 3NCT00724867

A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

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., a GSK Company at 51 sites in United States.

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 provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States, to evaluate the long-term safety and efficacy of belimumab(LymphoStat-B™) in subjects with 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?: No, everyone receives an active treatment
How many people: 268 participants
Where: 51 sitesUnited States
Study dates: Aug 2008to Mar 2015
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

Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.
Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose in HGS1006-c1056.

Who cannot join

Have developed any other medical disease or condition that has made the subject unsuitable for this study in the opinion of their physician.

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 sites

GSK Investigational Site
Ann Arbor, Michigan, 48109-5542
GSK Investigational Site
Arlington, Virginia, 22205-3606
GSK Investigational Site
Atlanta, Georgia, 30303
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Baltimore, Maryland, 21205
GSK Investigational Site
Baton Rouge, Louisiana, 70809
GSK Investigational Site
Bethlehem, Pennsylvania, 18015
GSK Investigational Site
Birmingham, Alabama, 35249
GSK Investigational Site
Brooklyn, New York, 11203
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Charleston, South Carolina, 29425
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Columbus, Ohio, 43203
GSK Investigational Site
Cumberland, Maryland, 21502
GSK Investigational Site
Dayton, Ohio, 45417
GSK Investigational Site
Great Neck, New York, 11021
GSK Investigational Site
Greenville, North Carolina, 27834
GSK Investigational Site
Greenville, South Carolina, 29601
GSK Investigational Site
Hagerstown, Maryland, 21740
GSK Investigational Site
Houston, Texas, 77004
GSK Investigational Site
Houston, Texas, 77034
GSK Investigational Site
Houston, Texas, 77074
GSK Investigational Site
Kansas City, Kansas, 66160
GSK Investigational Site
Lansing, Michigan, 48910
GSK Investigational Site
Long Beach, California, 90806
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
Munster, Indiana, 46321
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
Oklahoma City, Oklahoma, 74104
GSK Investigational Site
Onalaska, Wisconsin, 54650
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Pittsburgh, Pennsylvania, 15217
GSK Investigational Site
Rochester, New York, 14618
GSK Investigational Site
San Antonio, Texas, 78232
GSK Investigational Site
Seattle, Washington, 98133
GSK Investigational Site
Smithtown, New York, 11787
GSK Investigational Site
Sugar Land, Texas, 77479
GSK Investigational Site
Tampa, Florida, 33614
GSK Investigational Site
The Bronx, New York, 10461
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
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States

Read the detailed description

This is a long-term continuation study to provide continuing treatment to subjects who completed study HGS1006-C1056 in the United States. This study is to evaluate the long-term safety and efficacy of belimumab (LymphoStat-B™) in subjects with SLE disease.

Conditions: Systemic Lupus Erythematosus
Being tested: Belimumab 1 mg/kg, Belimumab 10 mg/kg
Keywords: Systemic Lupus Erythematosus, Belimumab, SLE, Antibodies, Lupus, Autoimmune Diseases
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.

Belimumab 1 mg/kgBiological
Also called BENLYSTA, HGS1006, LymphoStat-B™
Belimumab 1 mg/kg IV over one hour every 28 days
Belimumab 10 mg/kgBiological
Also called LymphoStat-B™, BENLYSTA, HGS1006
Belimumab 10 mg/kg IV over one hour every 28 days

Study groups in NCT00724867
Study group	Role	What they receive
Belimumab 1 mg/kg	Experimental	Belimumab 1 mg/kg IV every 28 days Receives: Biological: Belimumab 1 mg/kg
Belimumab 10 mg/kg	Experimental	Belimumab 10 mg/kg IV every 28 days Receives: Biological: Belimumab 10 mg/kg

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 untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.
Measured: Up to Week 440
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 treatment-emergent adverse events (AEs) are summarized. The Baseline is defined as the 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. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / Participant Years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Measured: Up Week 440
SAE Rates by System Organ Class (SOC) During the Study
SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The Baseline is defined as the 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. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / participants Years. participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Measured: Up to Week 440
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Change From Baseline in Erythrocytes at the Indicated Time Points
Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Change From Baseline in Hematocrit at the Indicated Time Points
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Change From Baseline in Hemoglobin at the Indicated Time Points
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Change From Baseline in Albumin and Protein at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Change From Baseline in BUN/Creatinine at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 432
Number of Participants With the Indicated Immunogenic Response
Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the 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. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 432
Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.
Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440

Secondary outcomes (15)

Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Serum immunoglobulin G (IgG) was collected at Baseline (BL) (Day 0), at Week 24 and Week 48 in first year, at Week 48 in subsequent years up to 8 years and at follow-up (up to 8 weeks post last infusion). Number of participants with serum immunoglobulins below the lower limit of normal (LLN) (<0.5 nanograms per milliliter [ng/mL]) are summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 392
Percentage of Participants Achieving SRI Response at Indicated Time Points
The percentage of participants achieving a SLE Responder Index (SRI) response at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion) are summarized. The BL is defined as the 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. Response is defined as:>=4 point reduction from the BL in the safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the BL) in Physicians 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 BL. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Anti-double stranded deoxyribonucleic acid (anti-dsDNA) levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks in participants who were positive at baseline (anti-dsDNA >=30 International Units/milliliter [IU/mL]). Observed anti-dsDNA levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 432
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Anti-dsDNA levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants who were positive at baseline (anti-dsDNA ≥30 IU/mL). Median percent change from Baseline in anti-dsDNA levels are summarized. The Baseline is defined as the 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. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value - Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 432
Observed Complement C3 and C4 Levels at Indicated Time Points
Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligram per deciliter (mg/dL) and C4 <16 mg/dL). Observed complement C3 and C4 levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 440
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligrams per decilitre (mg/dL) and C4 <16 mg/dL). Median percent change from Baseline in complement C3 and C4 levels are summarized. The Baseline is defined as the 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. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value - Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 432
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Trends for reduction in prednisone use in participants receiving belimumab were observed up to 432 weeks. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 432
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Proteinuria is defined as the presence of an excess of serum proteins in the urine. Trends for reduction in proteinuria in participants receiving belimumab were assessed up to 432 weeks and at Exit visit. Percentage of participants with >= 50% reduction in proteinuria among participants with Baseline proteinuria >0.5 g/24 hour (hr) are summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 432
Observed B-cell Levels at Indicated Time Points.
B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Observed absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 432
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Median percent change from Baseline in absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. The Baseline is defined as the 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. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value - Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Measured: Up to Week 432
Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index is a tool used to assess non-reversible organ damage in SLE patients. Damage Index is used to assess 12 systems by 41 items. Score is given as 1 or sometimes 2, if occur more than once, so that that the maximum possible score is 47. Higher damage index scores early in disease are associated with a poor prognosis and with increased mortality. Damage index was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. Percentage of participants with worsening in damage index (change >0) are summarized. The BL is defined as the 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. Only those participants available at the specified time points were analyzed ( n=X).
Measured: Up to Week 384
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
The SF-36v2 is a participant-reported short form survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the 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 BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).
Measured: Up to Week 384
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
The SF-36v2 is a participant-reported survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the 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 BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).
Measured: Up to Week 384
Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Wk 48 in first year, at Wk 48 in subsequent Yrs up to 8 Yrs.The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Change from BL in FACIT-Fatigue scale total score are summarized. The BL is defined as the 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 BL was calculated as the individual post-BL value minus the BL value. A negative change from BL represents a worsening condition. Only those participants available at the specified time points were analyzed ( n=X).
Measured: Up to Week 384
Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the minimum clinically important difference (MCID) (>=4 points) are summarized. Only those participants available at the specified time points were analyzed ( n=X).
Measured: Up to Week 384

Timeline

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

Aug 2008Mar 2015

First posted30 Jul 2008 (estimated)
Study startAug 2008
Primary completionMar 2015
Study completionMar 2015

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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 268 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00724867
Sponsor's protocol ID: 112233
Other IDs: HGS1006-C1066
Status last verified: Mar 2016
First submitted: 28 Jul 2008
Last updated: 28 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Strand V, Berry P, Lin X, Asukai Y, Punwaney R, Ramachandran S. Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in Patients With Systemic Lupus Erythematosus: Six Years of Treatment. Arthritis Care Res (Hoboken). 2019 Jun;71(6):829-838. doi: 10.1002/acr.23788. Epub 2019 Apr 29.
PubMed 30320964
Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States. Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 Apr 25.
PubMed 29409143

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?

See locations

Active, not recruitingPhase 3
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Active, not recruitingPhase 3
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 2
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Lupus Nephritis
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic

All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States
ClinicalTrials.gov ID: NCT00724867
Acronym / sponsor ID: 112233
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus, Belimumab, SLE, Antibodies, Lupus, Autoimmune Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 268 participants (actual)
Lead sponsor: Human Genome Sciences Inc., a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Aug 2008
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 30 Jul 2008 (estimated)
Results: Posted 28 Mar 2016

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Belimumab 1 mg/kg	Experimental	Biological: Belimumab 1 mg/kgBelimumab 1 mg/kg IV every 28 days
Belimumab 10 mg/kg	Experimental	Biological: Belimumab 10 mg/kgBelimumab 10 mg/kg IV every 28 days

Who may qualify

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

Key inclusion criteria (2 listed)

Have completed the HGS1006-C1056 protocol in the United States through Week 72 visit.
Be able to receive 1st dose of belimumab for HGS 1006-c1066 four weeks after last dose in HGS1006-c1056.

Key exclusion criteria (1 listed)

Have developed any other medical disease or condition that has made the subject unsuitable for this study in the opinion of their physician.

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
Belimumab 1 mg/kgAlso: BENLYSTA, HGS1006, LymphoStat-B™Belimumab 1 mg/kg IV over one hour every 28 days	Biological	Belimumab 1 mg/kg
Belimumab 10 mg/kgAlso: LymphoStat-B™, BENLYSTA, HGS1006Belimumab 10 mg/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: Up to Week 440
An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.
AE Rates by System Organ Class (SOC) During the Study
Time frame: Up Week 440
AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent adverse events (AEs) are summarized. The Baseline is defined as the 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. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / Participant Years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
SAE Rates by System Organ Class (SOC) During the Study
Time frame: Up to Week 440
SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The Baseline is defined as the 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. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / participants Years. participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
Time frame: Up to Week 440
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
Time frame: Up to Week 440
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Change From Baseline in Erythrocytes at the Indicated Time Points
Time frame: Up to Week 440
Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Change From Baseline in Hematocrit at the Indicated Time Points
Time frame: Up to Week 440
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Change From Baseline in Hemoglobin at the Indicated Time Points
Time frame: Up to Week 440
Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Change From Baseline in Albumin and Protein at the Indicated Time Points
Time frame: Up to Week 440
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
Time frame: Up to Week 440
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
Time frame: Up to Week 440
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Change From Baseline in Creatinine Clearance at the Indicated Time Points
Time frame: Up to Week 440
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Change From Baseline in BUN/Creatinine at the Indicated Time Points
Time frame: Up to Week 440
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
Time frame: Up to Week 432
Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Number of Participants With the Indicated Immunogenic Response
Time frame: Up to Week 440
Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the 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. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
Time frame: Up to Week 432
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
Time frame: Up to Week 440
Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.
Time frame: Up to Week 440
Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the 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. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

15 secondary outcomes

Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
Time frame: Up to Week 392
Percentage of Participants Achieving SRI Response at Indicated Time Points
Time frame: Up to Week 440
Observed Anti-double Stranded DNA Levels at Indicated Time Points.
Time frame: Up to Week 432
Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
Time frame: Up to Week 432
Observed Complement C3 and C4 Levels at Indicated Time Points
Time frame: Up to Week 440
Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
Time frame: Up to Week 432
Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
Time frame: Up to Week 432
Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
Time frame: Up to Week 432
Observed B-cell Levels at Indicated Time Points.
Time frame: Up to Week 432
Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
Time frame: Up to Week 432
Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
Time frame: Up to Week 384
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
Time frame: Up to Week 384
Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
Time frame: Up to Week 384
Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
Time frame: Up to Week 384
Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
Time frame: Up to Week 384

Results and safety

Results posted to the registry on 28 Mar 2016, 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	268	140

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

Time frame: Up to Week 440. Number. Unit: Participants

Measure	Belimumab 10 mg/kg IV n = 268
AE, Any time post baseline, n=268	267
AE, Year 0-1, n=268	260
AE, Year 1-2, n=259	235
AE, Year 2-3, n=244	206
AE, Year 3-4, n=219	184
AE, Year 4-5, n=202	167
AE, Year 5-6, n=192	145
AE, Year 6-7, n=130	87

Population analysed: Modified Intent to Treat (MIIT) Population: The MITT Population comprised of all the participants enrolled in the study who received at least one dose of IP.

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

Time frame: Up Week 440. Number. Unit: Adverse events/100 participant-years

Measure	Belimumab 10 mg/kg IV n = 268
Infections and infestations	134.4
Musculoskeletal and connective tissue disorders	75.5
Gastrointestinal disorders	53.6
Injury, poisoning and procedural complications	32.3
Skin and subcutaneous tissue disorders	30
Nervous system disorders	29.7
Respiratory, thoracic and mediastinal disorders	28.5
General disorders and administration sitecondition	27.9

Population analysed: MITT Population

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

Time frame: Up to Week 440. Number. Unit: Adverse events/100 participant-years

Measure	Belimumab 10 mg/kg IV n = 268
Infections and infestations	4
Gastrointestinal disorders	2.2
Musculoskeletal and connective tissue disorders	2
General disorders and administration sitecondition	1.7
Nervous system disorders	1.4
Injury, poisoning and procedural complications	1.4
Vascular disorders	1
Neoplasms benign, malignant and unspecified	1

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: Up to Week 440. Mean (Standard Deviation). Unit: Seconds

Measure	Belimumab 10 mg/kg IV n = 268
APTT, Year 1, Week 4, n= 82	1.3 (4.46)
APTT, Year 1, Week 12, n= 79	1 (4.56)
APTT, Year 1, Week 24, n= 243	0.7 (4.81)
APTT, Year 1, Week 36, n= 71	1.4 (4.83)
APTT, Year 1, Week 48, n= 246	1.7 (5.37)
APTT, Year 2, Week 24, n= 231	2.7 (5.88)
APTT, Year 2, Week 48, n= 220	3.9 (5.39)
APTT, Year 3, Week 24, n= 206	4.5 (4.92)

Population analysed: MITT Population

15 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 (up to Week 440).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Belimumab 10 mg/kg IV	112 of 268 (41.8%)	266 of 268 (99.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30320964Strand V, Berry P, Lin X, Asukai Y, Punwaney R, Ramachandran S. Long-Term Impact of Belimumab on Health-Related Quality of Life and Fatigue in Patients With Systemic Lupus Erythematosus: Six Years of Treatment. Arthritis Care Res (Hoboken). 2019 Jun;71(6):829-838. doi: 10.1002/acr.23788. Epub 2019 Apr 29.
Derived from this study: PubMed 29409143Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States. Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 Apr 25.

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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

51 sites in 1 country: see every site and its status.

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., a GSK Company at 51 sites in United States.

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 2 inclusion and 1 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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. 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 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 28 Mar 2016). 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: Up to Week 440). The study lists 18 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 NCT00724867, 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 28 Mar 2016; AzTrials last refreshed its copy on 31 Oct 2026.