A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab
18 Years
N/A
Both
Systemic Lupus Erythematosus
Trial Information
A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab
Study participants receive standard therapy for SLE in addition to receiving the study drug,
either placebo (no active medicine) or belimumab. The controlled period of the study is 52
weeks. The random assignment in this study is "1 to 1" which means that participants have an
equal chance of receiving belimumab or placebo. After completion of the 52-week study
period, participants will be contacted by phone annually for 4 more years to assess health
status.
Following the 52-week controlled period, participants who wish to continue treatment with
belimumab may be able to do so by being prescribed commercially available belimumab. If
belimumab is not commercially available in the participant's country, the participant may be
able to receive belimumab under a separate continuation protocol.
Key
Inclusion Criteria:
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen which may include corticosteroids (for example,
prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants
(for example, azathioprine, methotrexate, mycophenolate).
Key Exclusion Criteria:
- Pregnant or nursing.
- Have received treatment with any of the following: belimumab, either as a marketed
product or as an investigational agent; any B cell targeted therapy (for example,
rituximab) in the past year; or any biological agent (for example, adalimumab,
etanercept, infliximab, or anakinra) in the past 90 days.
- Have received a live vaccine within the past 30 days.
- Have severe active lupus kidney disease.
- Have severe active central nervous system (CNS) lupus.
- Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or
hepatitis C.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Incidence of all-cause mortality
Outcome Time Frame:
Up to 52 weeks
Safety Issue:
Yes
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
115467
NCT ID:
NCT01705977
Start Date:
November 2012
Completion Date:
January 2023
Related Keywords:
- Systemic Lupus Erythematosus
- Antibodies
- Lupus
- SLE
- Systemic Lupus Erythematosus
- Autoimmune Disease
- Belimumab
- Lupus Erythematosus, Systemic
Name | Location |
|---|---|
| GSK Investigational Site | Phoenix, Arizona 85013 - 4496 |
| GSK Investigational Site | Bakersfield, California 93309 |
| GSK Investigational Site | Gainesville, Florida 32610 |
| GSK Investigational Site | Raleigh, North Carolina 27609 |
| GSK Investigational Site | Akron, Ohio 44304 |
| GSK Investigational Site | Fort Worth, Texas 76104 |
| GSK Investigational Site | Savannah, Georgia 31405 |
| GSK Investigational Site | Royal Oak, Michigan 48073 |
| GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
| GSK Investigational Site | Columbia, South Carolina 29210 |
| GSK Investigational Site | Germantown, Tennessee 38138 |
| GSK Investigational Site | Salem, Virginia 24153 |
| GSK Investigational Site | Birmingham, Alabama 35209 |
| GSK Investigational Site | Hattiesburg, Mississippi 39401 |
| GSK Investigational Site | Seattle, Washington 98133 |
| GSK Investigational Site | Morgantown, West Virginia 26506 |
