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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00724867
First received: July 28, 2008
Last updated: March 10, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Systemic Lupus Erythematosus
Biological: Belimumab 1 mg/kg
Biological: Belimumab 10 mg/kg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) [ Time Frame: Up to Week 440 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points. [ Time Frame: Up to Week 392 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving SRI Response at Indicated Time Points [ Time Frame: Up to Week 440 ] [ Designated as safety issue: No ]
    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.

  • Observed Anti-double Stranded DNA Levels at Indicated Time Points. [ Time Frame: Up to Week 432 ] [ Designated as safety issue: No ]
    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.

  • Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points. [ Time Frame: Up to Week 432 ] [ Designated as safety issue: No ]
    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.

  • Observed Complement C3 and C4 Levels at Indicated Time Points [ Time Frame: Up to Week 440 ] [ Designated as safety issue: No ]
    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.

  • Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points [ Time Frame: Up to Week 432 ] [ Designated as safety issue: No ]
    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.

  • Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points. [ Time Frame: Up to Week 432 ] [ Designated as safety issue: No ]
    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.

  • Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points. [ Time Frame: Up to Week 432 ] [ Designated as safety issue: No ]
    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.

  • Observed B-cell Levels at Indicated Time Points. [ Time Frame: Up to Week 432 ] [ Designated as safety issue: No ]
    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.

  • Median Percent Change From Baseline in B Cell Levels at Indicated Time Points. [ Time Frame: Up to Week 432 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points [ Time Frame: Up to Week 384 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point [ Time Frame: Up to Week 384 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints [ Time Frame: Up to Week 384 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point [ Time Frame: Up to Week 384 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points [ Time Frame: Up to Week 384 ] [ Designated as safety issue: No ]
    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).


Enrollment: 268
Study Start Date: August 2008
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belimumab 1 mg/kg
Belimumab 1 mg/kg IV every 28 days
Biological: Belimumab 1 mg/kg
Belimumab 1 mg/kg IV over one hour every 28 days
Other Names:
  • BENLYSTA
  • HGS1006
  • LymphoStat-B™
Experimental: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV every 28 days
Biological: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV over one hour every 28 days
Other Names:
  • LymphoStat-B™
  • BENLYSTA
  • HGS1006

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Have developed any other medical disease or condition that has made the subject unsuitable for this study in the opinion of their physician.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00724867

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Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
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Additional Information:
Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT00724867     History of Changes
Other Study ID Numbers: 112233  HGS1006-C1066 
Study First Received: July 28, 2008
Results First Received: November 19, 2015
Last Updated: March 10, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Systemic Lupus Erythematosus
Belimumab
SLE
Antibodies
Lupus
Autoimmune Diseases

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2016