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TerminatedNCT00732940Updated Aug 7, 2013Results posted

Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 2 interventional study of Belimumab 100 mg SC and Belimumab 100 mg SC in Systemic Lupus Erythematosus, sponsored by Human Genome Sciences Inc.. Terminated at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-07.

Sponsored by Human Genome Sciences Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
Sponsor terminated study for business reasons.
Phase
Phase 2
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.

Read the detailed description

This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.

02

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • SLE
  • Lupus
  • Systemic Lupus Erythematosus
  • Antibodies
  • Autoimmune Diseases
  • Belimumab
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 56 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Human Genome Sciences Inc. is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
  • Active SLE disease
  • On stable SLE treatment regimen

Exclusion criteria

Exclusion Criteria:

  • Pregnant or nursing
  • Have received treatment with an B cell targeted therapy
  • Have received treatment with a biologic investigational agent in the past year
  • Have received intravenous (IV) cyclophosphamide within 180 days of Day 0
  • Have severe lupus kidney disease
  • Have active central nervous system (CNS) lupus
  • Have required management of acute or chronic infections with the past 60 days
  • Have current drug or alcohol abuse or dependence or within the past year
  • Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Belimumab Q2WKS

    Every other week: 100 mg of belimumab (1 injection) subcutaneous (under the skin) on days 0, 7, and 14, then every other week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.

    Drug: Belimumab 100 mg SC

  • Experimental
    Belimumab 3X/WK

    Three times weekly: 200 mg of belimumab (2 injections of 100 mg each) subcutaneous (under the skin) on days 0, 2, and 4 then 100 mg three times a week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.

    Drug: Belimumab 100 mg SC

Interventions

  • DrugBelimumab 100 mg SC

    Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.

    Also known as: LymphoStat-B™

  • DrugBelimumab 100 mg SC

    Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.

06

What researchers measure

Primary outcomes

  1. Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.

    SEE ALSO ADVERSE EVENTS RESULTS SECTION

    Time frame: Up to 24 weeks

  2. Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24

    Time frame: Baseline, 24 weeks

  3. Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.

    Time frame: Baseline, 24 Weeks

  4. Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24

    Time frame: Baseline, 24 weeks

  5. Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24

    Time frame: Baseline, 24 weeks

  6. Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24

    Time frame: Baseline, 24 Weeks

  7. Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24

    Time frame: Baseline, 24 Weeks

  8. Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24

    Time frame: Baseline, 24 Weeks

  9. Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24

    Time frame: Baseline, 24 Weeks

Secondary outcomes

  1. Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.

    Time frame: Baseline, 24 weeks

  2. Absolute Change From Baseline in IgA at Week 24

    Time frame: Baseline, 24 Weeks

  3. Median Percent Change From Baseline in IgA at Week 24

    Time frame: Baseline, 24 weeks

  4. Absolute Change From Baseline in IgG at Week 24

    Time frame: Baseline, 24 Weeks

  5. Median Percent Change From Baseline in IgG at Week 24

    Time frame: Baseline, 24 Weeks

  6. Absolute Change From Baseline in IgM at Week 24

    Time frame: Baseline, 24 Weeks

  7. Median Percent Change From Baseline in IgM at Week 24

    Time frame: Baseline, 24 weeks

  8. Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24

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

    Time frame: Baseline, 24 Weeks

  9. Mean Percent Change From Baseline in PGA Score at Week 24.

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

    Time frame: Baseline, 24 weeks

  10. Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24

    SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare.

    Time frame: Baseline, 24 Weeks

  11. Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24

    Time frame: Baseline, 24 weeks

  12. Absolute Change From Baseline in Complement C3 at Week 24

    Time frame: Baseline, 24 Weeks

  13. Median Percent Change From Baseline in Compliment C3 at Week 24

    Time frame: Baseline, 24 Weeks

  14. Absolute Change From Baseline in Complement C4 at Week 24

    Time frame: Baseline, 24 weeks

  15. Median Percent Change From Baseline in Complement C4 at Week 24

    Time frame: Baseline, 24 Weeks

  16. Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24

    Time frame: Baseline, 24 Weeks

  17. Median Percent Change From Baseline in Anti-dsDNA at Week 24

    Time frame: Baseline, 24 weeks

  18. Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24

    Time frame: Baseline, 24 Weeks

  19. Median Percent Change From Baseline in HDL at Week 24

    Time frame: Baseline, 24 week

  20. Absolute Change From Baseline in Total Cholesterol at Week 24

    Time frame: Baseline, 24 Weeks

  21. Median Percent Change From Baseline in Total Cholesterol at Week 24

    Time frame: Baseline, 24 Weeks

  22. Median Percent Change From Baseline in Triglycerides at Week 24

    Time frame: Baseline, 24 weeks

  23. Absolute Change From Baseline in Triglycerides at Week 24

    Time frame: Baseline, 24 Weeks

07

Results

Posted May 5, 2011

Participant flow

Participant flow — Overall Study
MilestoneBelimumab SC Q2WKSBelimumab SC 3X/WK
Started2828
Completed2625
Not completed23
Withdrew: Withdrawal by subject12
Withdrew: Adverse event01
Withdrew: Lost to follow-up10

Outcome measures

PrimaryEvaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.

SEE ALSO ADVERSE EVENTS RESULTS SECTION

Time frame:
Up to 24 weeks
Reported as:
Number · Percentage of participants
Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.
Percentage of participantsBelimumab SC Q2WKSBelimumab SC 3X/WK
Percent of patients with at least 1 AE89.385.7
Percent of patients with at least 1 Serious AE7.114.3
Percent of patients with an AE resulting in death00
SecondaryMean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.
Time frame:
Baseline, 24 weeks
Reported as:
Mean · µg/mL
Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.
µg/mLBelimumab SC Q2WKSBelimumab SC 3X/WK
Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.20.5 ± 11.6120.8 ± 53.7
SecondaryAbsolute Change From Baseline in IgA at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Mean · g/L
Absolute Change From Baseline in IgA at Week 24
g/LBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in IgA at Week 24-0.3 ± 0.08-0.3 ± 0.10
SecondaryMedian Percent Change From Baseline in IgA at Week 24
Time frame:
Baseline, 24 weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in IgA at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in IgA at Week 24-8.1 (-45.1 to 15.4)-10.7 (-36.4 to 34.1)
SecondaryAbsolute Change From Baseline in IgG at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Mean · g/L
Absolute Change From Baseline in IgG at Week 24
g/LBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in IgG at Week 24-2.2 ± 0.7-1.4 ± 0.7
SecondaryMedian Percent Change From Baseline in IgG at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in IgG at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in IgG at Week 24-11.1 (-47.0 to 12.1)-9.5 (-42.9 to 94.0)
SecondaryAbsolute Change From Baseline in IgM at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Mean · g/L
Absolute Change From Baseline in IgM at Week 24
g/LBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in IgM at Week 24-0.3 ± 0.04-0.4 ± 0.07
SecondaryMedian Percent Change From Baseline in IgM at Week 24
Time frame:
Baseline, 24 weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in IgM at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in IgM at Week 24-25.6 (-80.0 to 11.0)-26.9 (-71.6 to 170.6)
PrimaryAbsolute Change From Baseline in CD20+ (Total) B Cells at Week 24
Time frame:
Baseline, 24 weeks
Reported as:
Mean · cells/mm^3
Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24
cells/mm^3Belimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24-53.5 ± 20.4-75.3 ± 23.6
PrimaryMedian Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.
Time frame:
Baseline, 24 Weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.-33.5 ± 8.88-38.2 ± 13.26
PrimaryAbsolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24
Time frame:
Baseline, 24 weeks
Reported as:
Mean · cells/mm^3
Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24
cells/mm^3Belimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24-81.9 ± 18.5-95.0 ± 20.8
PrimaryMedian Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24
Time frame:
Baseline, 24 weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24-60.9 ± 6.47-66.7 ± 8.0
PrimaryAbsolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Mean · cells/mL
Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
cells/mLBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 241100.3 ± 389.8-77.2 ± 456.9
PrimaryMedian Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 2445.2 (-69.6 to 1496.3)10.2 (-87.0 to 779.6)
PrimaryAbsolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Mean · cells/mm^3
Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
cells/mm^3Belimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 2427.7 ± 6.019.6 ± 6.2
PrimaryMedian Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 2484.2 (-37.5 to 288.9)100.0 (-45.5 to 600.0)
SecondaryAbsolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24

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

Time frame:
Baseline, 24 Weeks
Reported as:
Mean · Scores on a 3-point scale
Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24
Scores on a 3-point scaleBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24-0.4 ± 0.09-0.4 ± 0.09
SecondaryMean Percent Change From Baseline in PGA Score at Week 24.

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

Time frame:
Baseline, 24 weeks
Reported as:
Mean · Percentage
Mean Percent Change From Baseline in PGA Score at Week 24.
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Mean Percent Change From Baseline in PGA Score at Week 24.-26.1 ± 6.6-24.8 ± 13.1
SecondaryAbsolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare.

Time frame:
Baseline, 24 Weeks
Reported as:
Mean · Points on a scale
Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24
Points on a scaleBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24-2.9 ± 0.8-3.1 ± 0.5
SecondaryMean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24
Time frame:
Baseline, 24 weeks
Reported as:
Mean · Percentage
Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24-35.8 ± 9.1-40.5 ± 8.6
SecondaryAbsolute Change From Baseline in Complement C3 at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Mean · mg/L
Absolute Change From Baseline in Complement C3 at Week 24
mg/LBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in Complement C3 at Week 24188.0 ± 51.54.0 ± 44.3
SecondaryMedian Percent Change From Baseline in Compliment C3 at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in Compliment C3 at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in Compliment C3 at Week 2425.8 (13.6 to 55.4)3.6 (-25.7 to 33.3)
SecondaryAbsolute Change From Baseline in Complement C4 at Week 24
Time frame:
Baseline, 24 weeks
Reported as:
Mean · mg/dL
Absolute Change From Baseline in Complement C4 at Week 24
mg/dLBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in Complement C4 at Week 247.2 ± 1.72.3 ± 1.4
SecondaryMedian Percent Change From Baseline in Complement C4 at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in Complement C4 at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in Complement C4 at Week 2476.9 (0 to 133.3)40.0 (-46.7 to 200.0)
SecondaryAbsolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Mean · IU/mL
Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24
IU/mLBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24-33.1 ± 11.1-6.0 ± 12.2
SecondaryMedian Percent Change From Baseline in Anti-dsDNA at Week 24
Time frame:
Baseline, 24 weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in Anti-dsDNA at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in Anti-dsDNA at Week 24-24.0 (-51.4 to 18.4)0.0 (-57.2 to 125.8)
SecondaryAbsolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Mean · mmol/L
Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24
mmol/LBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 240.1 ± 0.040.0 ± 0.08
SecondaryMedian Percent Change From Baseline in HDL at Week 24
Time frame:
Baseline, 24 week
Reported as:
Median · Percentage
Median Percent Change From Baseline in HDL at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in HDL at Week 244.8 (-16.1 to 34.6)2.2 (-38.2 to 72.7)
SecondaryAbsolute Change From Baseline in Total Cholesterol at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Mean · mmol/L
Absolute Change From Baseline in Total Cholesterol at Week 24
mmol/LBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in Total Cholesterol at Week 240.1 ± 0.090.0 ± 0.20
SecondaryMedian Percent Change From Baseline in Total Cholesterol at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in Total Cholesterol at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in Total Cholesterol at Week 241.0 (-17.2 to 20.9)1.6 (-36.3 to 45.7)
SecondaryMedian Percent Change From Baseline in Triglycerides at Week 24
Time frame:
Baseline, 24 weeks
Reported as:
Median · Percentage
Median Percent Change From Baseline in Triglycerides at Week 24
PercentageBelimumab SC Q2WKSBelimumab SC 3X/WK
Median Percent Change From Baseline in Triglycerides at Week 24-4.9 (-46.9 to 183.0)4.5 (-59.4 to 120.6)
SecondaryAbsolute Change From Baseline in Triglycerides at Week 24
Time frame:
Baseline, 24 Weeks
Reported as:
Mean · mmol/L
Absolute Change From Baseline in Triglycerides at Week 24
mmol/LBelimumab SC Q2WKSBelimumab SC 3X/WK
Absolute Change From Baseline in Triglycerides at Week 24-0.1 ± 0.14-0.0 ± 0.15

Adverse events

Collected over Up to 24 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Belimumab SC Q2WKS—2/28 (7.1%)19/28 (67.9%)
Belimumab SC 3X/WK—4/28 (14.3%)18/28 (64.3%)
Most frequent serious events
Most frequent serious events
EventBelimumab SC Q2WKSBelimumab SC 3X/WK
Acute myocardial infarctionCardiac disorders1/280/28
BradycardiaCardiac disorders0/281/28
Retroperitoneal haemorrhageGastrointestinal disorders1/280/28
CellulitisInfections and infestations0/281/28
GastroenteritisInfections and infestations0/281/28
Pneumococcal sepsisInfections and infestations0/281/28
PyelonephritisInfections and infestations1/280/28
Subcutaneous abscessInfections and infestations0/281/28
Most frequent other events
Showing 10 of 25
Most frequent other events
EventBelimumab SC Q2WKSBelimumab SC 3X/WK
HeadacheNervous system disorders6/285/28
NasopharyngitisInfections and infestations5/280/28
Upper respiratory tract infectionInfections and infestations5/283/28
DiarrhoeaGastrointestinal disorders4/281/28
ArthralgiaMusculoskeletal and connective tissue disorders3/284/28
NauseaGastrointestinal disorders2/283/28
FatigueGeneral disorders3/282/28
SinusitisInfections and infestations0/283/28
ArthritisMusculoskeletal and connective tissue disorders1/283/28
MyalgiaMusculoskeletal and connective tissue disorders3/282/28

Baseline characteristics

Age Continuous
Age Continuous(years)Belimumab SC Q2WKSBelimumab SC 3X/WKTotal
Mean39.2 ± 11.540.9 ± 13.140.1 ± 12.2
Sex: Female, Male
Sex: Female, Male(Participants)Belimumab SC Q2WKSBelimumab SC 3X/WKTotal
Female262753
Male213
Region of Enrollment
Region of Enrollment(participants)Belimumab SC Q2WKSBelimumab SC 3X/WKTotal
United States242549
Mexico437
08

Study locations

11 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35249-7201, United States
  • Valerious Medical Group Research Center
    Long Beach, California 90806, United States
  • Tampa Medical Group, PA
    Tampa, Florida 33614, United States
  • Fiechtner Research, Inc.
    Lansing, Michigan 48910, United States
  • SUNY Downstate Medical Center
    Brooklyn, New York 11203, United States
  • North Shore-LIJ Health System/Rheumatology, Allergy, Immunology
    Lake Success, New York 11042, United States
  • Rheumatology Associates
    Smithtown, New York 11787, United States
  • STAT Research, Inc.
    Dayton, Ohio 45408, United States
  • Oklahoma Center for Arthritis Therapy & Research
    Tulsa, Oklahoma 74104, United States
  • Houston Institute for Clinical Research
    Houston, Texas 77074, United States
  • Hospital Central "Igancio Morones Prieto"
    San Lusi Potosi, 78240, Mexico
09

References and documents

Publications

  • van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279. PubMed 31302695 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00732940
Lead sponsor
Human Genome Sciences Inc.
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 12, 2008
Start date
Oct 2008
Primary completion
Oct 2009
Completion
Mar 2012
Results posted
May 5, 2011
Last update
Aug 7, 2013

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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