Clinical trial NCT00583362: A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
Official title: A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Lupus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2007-12-31
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.

Detailed description: The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.

Eligibility criteria: Primary Inclusion Criteria

1. Have completed the LBSL02 trial and achieved a satisfactory response.

Primary Exclusion Criteria

1. Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
2. Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.
3. Used any of the following prohibited medications during their participation in LBSL02:

   * Other investigational agents.
   * Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™).
   * Intravenous cyclophosphamide.
   * Corticosteroids \>100 mg/day prednisone equivalent for reasons other than severe SLE flare.

Primary outcomes:
measure: Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)
timeFrame: Approximately up to 13 years
measure: Adverse Event (AE) Rates by System Organ Class (SOC) During the Study
timeFrame: Approximately up to 13 years
measure: SAE Rates by System Organ Class (SOC) During the Study
timeFrame: Approximately up to 13 years
measure: Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
measure: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
measure: Change From Baseline in Erythrocytes at the Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
measure: Change From Baseline in Hematocrit at the Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
measure: Change From Baseline in Hemoglobin at the Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
measure: Change From Baseline in Albumin and Protein at the Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
measure: Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
measure: Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
measure: Change From Baseline in BUN/Creatinine at the Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
measure: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
Secondary outcomes:
measure: Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points
timeFrame: Approximately up to 13 years
measure: Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points
timeFrame: Approximately up to 13 years
measure: Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
measure: Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
timeFrame: Approximately up to 13 years
measure: Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
measure: Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points
timeFrame: Approximately up to 13 years
measure: Absolute Serum Immunoglobulin G Values at Indicated Time Points
timeFrame: Approximately up to 13 years
measure: Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points
timeFrame: Baseline and approximately up to 13 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Scottsdale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: La Jolla
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: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Jose
country: United States
facility: GSK Investigational Site
state: California
city: Upland
country: United States
facility: GSK Investigational Site
state: California
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
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: Boise
country: United States
facility: GSK Investigational Site
state: Idaho
city: Idaho Falls
country: United States
facility: GSK Investigational Site
state: Idaho
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: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Cumberland
country: United States
facility: GSK Investigational Site
state: Maryland
city: Wheaton
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Concord
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Dover
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Albany
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: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Willow Grove
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
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: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Onalaska
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ginzler EM, Wallace DJ, Merrill JT, Furie RA, Stohl W, Chatham WW, Weinstein A, McKay JD, McCune WJ, Zhong ZJ, Freimuth WW, Petri MA; LBSL02/99 Study Group. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014 Feb;41(2):300-9. doi: 10.3899/jrheum.121368. Epub 2013 Nov 1.
citation: Merrill JT, Ginzler EM, Wallace DJ, McKay JD, Lisse JR, Aranow C, Wellborne FR, Burnette M, Condemi J, Zhong ZJ, Pineda L, Klein J, Freimuth WW; LBSL02/99 Study Group. Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Oct;64(10):3364-73. doi: 10.1002/art.34564.