Clinical trial NCT00724867: A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Belimumab
SLE
Antibodies
Lupus
Autoimmune Diseases
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-07-30
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
timeFrame: Up to Week 440
measure: AE Rates by System Organ Class (SOC) During the Study
timeFrame: Up Week 440
measure: SAE Rates by System Organ Class (SOC) During the Study
timeFrame: Up to Week 440
measure: Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
timeFrame: Up to Week 440
measure: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points
timeFrame: Up to Week 440
measure: Change From Baseline in Erythrocytes at the Indicated Time Points
timeFrame: Up to Week 440
measure: Change From Baseline in Hematocrit at the Indicated Time Points
timeFrame: Up to Week 440
measure: Change From Baseline in Hemoglobin at the Indicated Time Points
timeFrame: Up to Week 440
measure: Change From Baseline in Albumin and Protein at the Indicated Time Points
timeFrame: Up to Week 440
measure: Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
timeFrame: Up to Week 440
measure: Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
timeFrame: Up to Week 440
measure: Change From Baseline in Creatinine Clearance at the Indicated Time Points
timeFrame: Up to Week 440
measure: Change From Baseline in BUN/Creatinine at the Indicated Time Points
timeFrame: Up to Week 440
measure: Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points
timeFrame: Up to Week 432
measure: Number of Participants With the Indicated Immunogenic Response
timeFrame: Up to Week 440
measure: Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.
timeFrame: Up to Week 432
measure: Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.
timeFrame: Up to Week 440
measure: 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.
timeFrame: Up to Week 440
Secondary outcomes:
measure: Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.
timeFrame: Up to Week 392
measure: Percentage of Participants Achieving SRI Response at Indicated Time Points
timeFrame: Up to Week 440
measure: Observed Anti-double Stranded DNA Levels at Indicated Time Points.
timeFrame: Up to Week 432
measure: Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.
timeFrame: Up to Week 432
measure: Observed Complement C3 and C4 Levels at Indicated Time Points
timeFrame: Up to Week 440
measure: Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points
timeFrame: Up to Week 432
measure: Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.
timeFrame: Up to Week 432
measure: Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.
timeFrame: Up to Week 432
measure: Observed B-cell Levels at Indicated Time Points.
timeFrame: Up to Week 432
measure: Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.
timeFrame: Up to Week 432
measure: Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points
timeFrame: Up to Week 384
measure: Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point
timeFrame: Up to Week 384
measure: Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints
timeFrame: Up to Week 384
measure: Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point
timeFrame: Up to Week 384
measure: Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points
timeFrame: Up to Week 384
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Upland
country: United States
facility: GSK Investigational Site
state: California
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Aventura
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Munster
country: United States
facility: GSK Investigational Site
state: Indiana
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Cumberland
country: United States
facility: GSK Investigational Site
state: Maryland
city: Hagerstown
country: United States
facility: GSK Investigational Site
state: Maryland
city: Ann Arbor
country: United States
facility: GSK Investigational Site
state: Michigan
city: Lansing
country: United States
facility: GSK Investigational Site
state: Michigan
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Brooklyn
country: United States
facility: GSK Investigational Site
state: New York
city: Great Neck
country: United States
facility: GSK Investigational Site
state: New York
city: Manhasset
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Smithtown
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Bethlehem
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: GSK Investigational Site
state: Texas
city: Arlington
country: United States
facility: GSK Investigational Site
state: Virginia
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Onalaska
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.