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

Use our guide to learn which trials are right for you!

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
Orangeburg, South Carolina 29118
Phone: 877-379-3718
2122
mi
from 91732
Orangeburg, SC
Click here to add this to my saved trials
Anniston, Alabama 36207
Phone: 877-379-3718
1838
mi
from 91732
Anniston, AL
Click here to add this to my saved trials
Arlington, Virginia 22205
Phone: 877-379-3718
2275
mi
from 91732
Arlington, VA
Click here to add this to my saved trials
Beckley, West Virginia 25801
Phone: 877-379-3718
2062
mi
from 91732
Beckley, WV
Click here to add this to my saved trials
Birmingham, Alabama 35249
Phone: 877-379-3718
1777
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Capital Federal, Buenos Aires
Phone: 877-379-3718
6113
mi
from 91732
Capital Federal,
Click here to add this to my saved trials
Cedar Rapids, Iowa 52403
Phone: 877-379-3718
1530
mi
from 91732
Cedar Rapids, IA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
Phone: 877-379-3718
2194
mi
from 91732
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29425
Phone: 877-379-3718
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
Phone: 877-379-3718
2100
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45229
Phone: 877-379-3718
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Clarksburg, West Virginia 26301
Phone: 877-379-3718
2102
mi
from 91732
Clarksburg, WV
Click here to add this to my saved trials
Clearwater, Florida 33759
Phone: 877-379-3718
2122
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
Columbus, Ohio 43219
Phone: 877-379-3718
1965
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
Covina, California 91723
Phone: 877-379-3718
7
mi
from 91732
Covina, CA
Click here to add this to my saved trials
Cypress, Texas 77429
1308
mi
from 91732
Cypress, TX
Click here to add this to my saved trials
Dallas, Texas 75230
Phone: 877-379-3718
1223
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
Phone: 877-379-3718
2201
mi
from 91732
Duncansville, PA
Click here to add this to my saved trials
Fremont, California 94538
Phone: 877-379-3718
324
mi
from 91732
Fremont, CA
Click here to add this to my saved trials
Glendale, Arizona 85304
Phone: 877-379-3718
336
mi
from 91732
Glendale, AZ
Click here to add this to my saved trials
Hialeah, Florida 33013
Phone: 877-379-3718
2315
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
Hixson, Tennessee 37343
Phone: 877-379-3718
1856
mi
from 91732
Hixson, TN
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 877-379-3718
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92647
Phone: 877-379-3718
24
mi
from 91732
Huntington Beach, CA
Click here to add this to my saved trials
Huntsville, Alabama 35801
Phone: 877-379-3718
1786
mi
from 91732
Huntsville, AL
Click here to add this to my saved trials
Jackson, Mississippi 39202
Phone: 877-379-3718
1609
mi
from 91732
Jackson, MS
Click here to add this to my saved trials
Jackson, Mississippi 39202
1609
mi
from 91732
Jackson, MS
Click here to add this to my saved trials
Kalispell, Montana 59901
Phone: 877-379-3718
993
mi
from 91732
Kalispell, MT
Click here to add this to my saved trials
La Mesa, California 91942
Phone: 877-379-3718
106
mi
from 91732
La Mesa, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
214
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
Long Beach, California 90813
Phone: 877-379-3718
22
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90025
Phone: 877-379-3718
24
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
McKinney, Texas 75071
Phone: 877-379-3718
1228
mi
from 91732
McKinney, TX
Click here to add this to my saved trials
Memphis, Tennessee 38120
Phone: 877-379-3718
1597
mi
from 91732
Memphis, TN
Click here to add this to my saved trials
Mesa, Arizona 85206
Phone: 877-379-3718
365
mi
from 91732
Mesa, AZ
Click here to add this to my saved trials
Murrieta, California 92563
Phone: 877-379-3718
59
mi
from 91732
Murrieta, CA
Click here to add this to my saved trials
New York, New York 10032
Phone: 877-379-3718
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
New York, New York 10032
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
Paradise Valley, Arizona 85253
350
mi
from 91732
Paradise Valley, AZ
Click here to add this to my saved trials
Peachtree City, Georgia 30269
1912
mi
from 91732
Peachtree City, GA
Click here to add this to my saved trials
Phoenix, Arizona 85012
Phone: 877-379-3718
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85012
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
Rock Hill, South Carolina 29732
Phone: 877-379-3718
2094
mi
from 91732
Rock Hill, SC
Click here to add this to my saved trials
Sacramento, California 95815
Phone: 877-379-3718
365
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
Saint Clair Shores, Michigan 48081
1975
mi
from 91732
Saint Clair Shores, MI
Click here to add this to my saved trials
San Leandro, California 94578
340
mi
from 91732
San Leandro, CA
Click here to add this to my saved trials
Spokane, Washington 99208
Phone: 877-379-3718
947
mi
from 91732
Spokane, WA
Click here to add this to my saved trials
Tampa, Florida 33612
Phone: 877-379-3718
2134
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Webster, Texas 77450
Phone: 877-379-3718
1337
mi
from 91732
Webster, TX
Click here to add this to my saved trials
West Bloomfield, Michigan 48322
1952
mi
from 91732
West Bloomfield, MI
Click here to add this to my saved trials
Whittier, California 90606
Phone: 877-379-3718
6
mi
from 91732
Whittier, CA
Click here to add this to my saved trials
Wyomissing, Pennsylvania 19610
Phone: 877-379-3718
2331
mi
from 91732
Wyomissing, PA
Click here to add this to my saved trials