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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Systemic Lupus Erythematosus

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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 SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteBirmingham, Alabama  35209
GSK Investigational SiteHattiesburg, Mississippi  39401
GSK Investigational SiteSeattle, Washington  98133
GSK Investigational SiteMorgantown, West Virginia  26506