Belimumab Assessment of Safety in SLE



Status:Active, not recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:10/14/2018
Start Date:November 27, 2012
End Date:July 21, 2022

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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

The purpose of this study is to further enhance the existing knowledge regarding the side
effects of belimumab when given with other lupus medicines to adults with active systemic
lupus erythematosus (SLE). This study mainly focuses on collecting information on serious
events that are not that common or may only be seen with long-term treatment. These events
include death, serious infections and other infections of interest, cancers, serious mental
health problems, including depression and suicide, and serious infusion and hypersensitivity
reactions. This study is being done to help understand if treatment with belimumab increases
the risk for these types of events. This study will also see if patients receiving belimumab
with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

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.
We found this trial at
55
sites
Beckley, West Virginia 25801
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Anniston, Alabama 36207
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Arlington, Virginia 22205
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Birmingham, Alabama 35249
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Capital Federal, Buenos Aires
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Cedar Rapids, Iowa 52403
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Chapel Hill, North Carolina 27599
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Charleston, South Carolina 29425
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Charlotte, North Carolina 28203
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Cincinnati, Ohio 45229
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Clarksburg, West Virginia 26301
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Clearwater, Florida 33759
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Columbus, Ohio 43219
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Covina, California 91723
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Cypress, Texas 77429
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Dallas, Texas 75230
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Duncansville, Pennsylvania 16635
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Fremont, California 94538
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Glendale, Arizona 85304
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Hialeah, Florida 33013
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Hixson, Tennessee 37343
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Houston, Texas 77030
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Houston, Texas 77030
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Houston, Texas 77030
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Houston, Texas 77030
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Huntington Beach, California 92647
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Huntsville, Alabama 35801
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Jackson, Mississippi 39202
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Jackson, Mississippi 39202
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Kalispell, Montana 59901
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La Mesa, California 91942
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Las Vegas, Nevada 89102
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Long Beach, California 90813
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Los Angeles, California 90025
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McKinney, Texas 75071
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Memphis, Tennessee 38120
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Mesa, Arizona 85206
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Murrieta, California 92563
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New York, New York 10032
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New York, New York 10032
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Orangeburg, South Carolina 29118
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Paradise Valley, Arizona 85253
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Peachtree City, Georgia 30269
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Phoenix, Arizona 85012
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Phoenix, Arizona 85012
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Rock Hill, South Carolina 29732
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Sacramento, California 95815
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Saint Clair Shores, Michigan 48081
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San Leandro, California 94578
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Spokane, Washington 99208
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Tampa, Florida 33612
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Webster, Texas 77450
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West Bloomfield, Michigan 48322
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Whittier, California 90606
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Wyomissing, Pennsylvania 19610
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