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Trial record 4 of 105 for:    selena

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

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ClinicalTrials.gov Identifier: NCT00071487
Recruitment Status : Completed
First Posted : October 28, 2003
Results First Posted : August 28, 2012
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Human Genome Sciences Inc.

Tracking Information
First Submitted Date  ICMJE October 24, 2003
First Posted Date  ICMJE October 28, 2003
Results First Submitted Date  ICMJE February 27, 2012
Results First Posted Date  ICMJE August 28, 2012
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE October 2003
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
  • Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. [ Time Frame: Baseline, 24 weeks ]
    SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.
  • Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) [ Time Frame: 0 to 52 weeks ]
    The SLE Flare Index categorized SLE flare as "mild or moderate" or "severe" based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
  • Percentage Change From Baseline in SELENA SLEDAI Score at Week 52 [ Time Frame: Baseline, 52 weeks ]
    SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare
  • Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52 [ Time Frame: Baseline and every 4 to 8 weeks through Week 52 ]
    SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.
  • Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52 [ Time Frame: Baseline, 52 weeks ]
    The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.
  • Area Under the Curve (AUC) of BILAG Score at Week 52 [ Time Frame: Baseline and every 4 to 8 weeks through Week 52 ]
    The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score.
  • Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks [ Time Frame: 0 to 52 weeks ]
    SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.
  • Percentage of Patients With a Reduction in Prednisone Dose [ Time Frame: Baseline, weeks 40 to 52 ]
    Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 25, 2012)
Adverse Events (AE) Overview [ Time Frame: Up to 84 weeks ]
Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)
Brief Summary The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
Detailed Description The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active SLE disease. Patients were randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7 versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy for SLE). All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 52 weeks. Patients completing the 52-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lupus Erythematosus, Systemic
Intervention  ICMJE
  • Drug: Placebo
    Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
  • Drug: Belimumab 1 mg/kg
    Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
    Other Names:
    • LymphoStat-B®
    • BENLYSTA®
  • Drug: Belimumab 4 mg/kg
    Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
    Other Names:
    • LymphoStat-B®
    • BENLYSTA®
  • Drug: Belimumab 10 mg/kg
    Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.
    Other Names:
    • LymphoStat-B®
    • BENLYSTA®
Study Arms  ICMJE
  • Placebo Comparator: Placebo plus SOC
    Intervention: Drug: Placebo
  • Experimental: Belimumab 1 mg/kg plus SOC
    Intervention: Drug: Belimumab 1 mg/kg
  • Experimental: Belimumab 4 mg/kg plus SOC
    Intervention: Drug: Belimumab 4 mg/kg
  • Experimental: Belimumab 10 mg/kg plus SOC
    Intervention: Drug: Belimumab 10 mg/kg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2007)
449
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Primary Inclusion Criteria

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

Primary Exclusion Criteria

  • Received a non-FDA approved investigational agent within last 28 days
  • Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days
  • Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 90 days
  • Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days
  • History of renal transplant
  • History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days
  • History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency
  • Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00071487
Other Study ID Numbers  ICMJE LBSL02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Human Genome Sciences Inc.
Study Sponsor  ICMJE Human Genome Sciences Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account Human Genome Sciences Inc.
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP