Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry



Status:Recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:7/18/2018
Start Date:February 21, 2013
End Date:January 31, 2025
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab)

The purpose of this registry is to collect additional information regarding the side effects
and effectiveness of BENLYSTA (belimumab) when given with other lupus medicines to adults
with active systemic lupus erythematosus (SLE). Information will be collected on serious
events that are not that common or may only be seen with long-term treatment. These events
include death, cancers, serious infections and other infections of interest, and serious
mental health problems. Information on the effectiveness of BENLYSTA will also be collected.

The registry will enroll 2 groups of patients. One group will include patients who are
currently taking lupus medicines along with BENLYSTA (With BENLYSTA). The other group will
include patients who are taking lupus medicines but do not take BENLYSTA (Without BENLYSTA).
For every 3 participants enrolled in the registry, 2 will be taking BENLYSTA and 1 will not.
After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are
at the discretion of the physician, and all patients will continue to be followed regardless
of changes in their lupus medicines until study completion. Physicians will manage the
patient in accordance with their medical judgment and standard of care. Data will be
collected at enrollment and at 6 month intervals for 5 years.

Key Inclusion Criteria:

- Clinical diagnosis of active SLE.

- Autoantibody-positive.

- Current SLE treatment includes BENLYSTA and/or immunosuppressants (for example,
azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics).

Key Exclusion Criteria:

- Have received treatment with an investigational agent within the past year.

- Are currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or
a continuation trial in which belimumab is used as an investigational agent.

- Have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.

- Current SLE treatment includes only an antimalarial (for example, hydroxychloroquine)
or only steroids.
We found this trial at
109
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Birmingham, Alabama 35249
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Ann Arbor, Michigan 48109
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Atlanta, Georgia 30341
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Baltimore, Maryland 21201
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Baton Rouge, Louisiana 70809
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Bronx, New York 10461
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Camden, New Jersey 08103
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Charleston, South Carolina 29425
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Charleston, South Carolina 29425
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Charlotte, North Carolina 28203
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Charlotte, North Carolina 28203
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Charlotte, North Carolina 28203
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Chicago, Illinois 60611
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Chicago, Illinois 60611
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Clearwater, Florida 33759
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Columbia, South Carolina 29203
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Columbus, Ohio 43219
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Covina, California 91723
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Culver City, California 90232
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Danbury, Connecticut 06810
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Danville, Virginia 24541
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Detroit, Michigan 48202
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Duncansville, Pennsylvania 16635
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Eagan, Minnesota 55121
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Edina, Minnesota 55435
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Edmond, Oklahoma 73013
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Fort Lauderdale, Florida 33308
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Gainesville, Georgia 30501
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Hamden, Connecticut 06518
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Henderson, Nevada 89052
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Hixson, Tennessee 37343
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Homestead, Florida 33030
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Houston, Texas 77030
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Jackson, Mississippi 39202
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Juniper, Florida 33458
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La Mesa, California 91942
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Lake Charles, Louisiana 70601
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Lakewood, California 90712
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Lansing, Michigan 48917
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Largo, Florida 33770
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Lexington, Kentucky 40504
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Loma Linda, California 92357
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Los Angeles, California 90025
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Manhasset, New York 11030
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Manitowoc, Wisconsin 54221
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Marietta, Georgia 30060
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Meridian, Idaho 83642
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Miami, Florida 33136
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Mineola, New York 11501
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Morton Grove, Illinois 60053
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Murrieta, California 92563
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Nashville, Tennessee 37203
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Nassau Bay, Texas 77058
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New Bern, North Carolina 28562
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New York, New York 10032
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Norfolk, Virginia 23502
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North Miami Beach, Florida 33179
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Oklahoma City, Oklahoma 73112
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Oklahoma City, Oklahoma 73112
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Omaha, Nebraska 68131
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Palm Harbor, Florida 34684
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Parana, Entre Ríos
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Pembroke Pines, Florida 33028
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Pensacola, Florida 32503
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Pittsburgh, Pennsylvania 15213
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Plano, Texas 75093
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Plantation, Florida 33324
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Pomona, California 91767
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Raleigh, North Carolina 27614
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Roanoke, Virginia 24013
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Rocky Mount, North Carolina 27804
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Roslyn, New York 11576
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Saint Louis, Missouri 63110
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Seattle, Washington 98109
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Shreveport, Louisiana 71103
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Smithtown, New York 11787
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South Bend, Indiana 46601
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Springfield, Massachusetts 01199
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Summit, New Jersey 07901
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Teaneck, New Jersey 07666
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Thousand Oaks, California 91360
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Toledo, Ohio 43608
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