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Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry (SABLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01729455
Recruitment Status : Active, not recruiting
First Posted : November 20, 2012
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

Brief Summary:
The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Biological: BENLYSTA Other: SLE treatment

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Study Type : Observational [Patient Registry]
Actual Enrollment : 3138 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Years
Official Title: 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)
Actual Study Start Date : February 21, 2013
Estimated Primary Completion Date : January 16, 2025
Estimated Study Completion Date : January 16, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab

Group/Cohort Intervention/treatment
BENLYSTA cohort
Participants with active, autoantibody-positive SLE treated with BENLYSTA at Baseline.
Biological: BENLYSTA

As prescribed.

Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus.

Other Name: belimumab

Other: SLE treatment

As prescribed.

At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.


Comparison cohort
Participants with active, autoantibody-positive SLE treated without BENLYSTA at Baseline.
Other: SLE treatment

As prescribed.

At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.





Primary Outcome Measures :
  1. Number of participants with AESI [ Time Frame: Up to 5 years ]
    AESI including malignancies (excluding non-melanoma skin cancers), non-melanoma skin cancers (NMSC), mortality, serious infections, opportunistic infections and other infections of interest, and selected serious psychiatric events will be summarized.


Other Outcome Measures:
  1. Number of participants with organ damage [ Time Frame: Up to 5 years ]
    Organ damage will be assessed by System Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI). It is designed to capture items of irreversible organ damage present for at least 6 months occurring in participants with SLE regardless of exact cause. It consists of 12 organ system scales each having subscales which comprises of up to 6 components.

  2. Number of participants with use of concomitant SLE medications [ Time Frame: Up to 5 years ]
    Concomitant SLE medications including steroids are the medications used to treat SLE (immunosuppressants, anti-malarials, corticosteroids, biologics, and investigational agents for SLE).

  3. Number of participants with hospitalizations [ Time Frame: Up to 5 years ]
    An inpatient hospitalization is defined as an admission for greater than 24 hours. An admission for administration of medication or for routine or planned clinical procedures will not be considered a hospitalization. Dates of hospital admission and discharge, and whether the hospitalization was SLE-related will be collected, as available.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with active autoantibody-positive SLE.
Criteria

Inclusion Criteria:

  • Males or females age 18 years or older.
  • Have a clinical diagnosis of active SLE.
  • Current or history of autoantibody-positive SLE.
  • Must be treated with SLE therapy including BENLYSTA and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics).
  • Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures.

Exclusion Criteria:

  • Treatment with an investigational drug within one year of enrollment. Investigational drug applies to any drug not approved for sale in the country it is being used.
  • Currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation protocol where belimumab is used as an investigational agent.
  • Participants who have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.
  • Participants only receiving an anti-malarial for SLE.
  • Participants only receiving steroids for SLE.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729455


Locations
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United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
United States, Arizona
GSK Investigational Site
Glendale, Arizona, United States, 85304
GSK Investigational Site
Goodyear, Arizona, United States, 85395
GSK Investigational Site
Phoenix, Arizona, United States, 85032
GSK Investigational Site
Phoenix, Arizona, United States, 85037
GSK Investigational Site
Tucson, Arizona, United States, 85704
GSK Investigational Site
Tucson, Arizona, United States, 85712
United States, California
GSK Investigational Site
Bakersfield, California, United States, 93301
GSK Investigational Site
Glendale, California, United States, 91204
GSK Investigational Site
La Mesa, California, United States, 92020
GSK Investigational Site
Lakewood, California, United States, 90712
GSK Investigational Site
Loma Linda, California, United States, 92354
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
Los Angeles, California, United States, 90048
GSK Investigational Site
Los Angeles, California, United States, 90095
GSK Investigational Site
Murrieta, California, United States, 92563
GSK Investigational Site
Pomona, California, United States, 91767
GSK Investigational Site
Upland, California, United States, 91786
GSK Investigational Site
West Hills, California, United States, 91307
United States, Connecticut
GSK Investigational Site
Danbury, Connecticut, United States, 06810
GSK Investigational Site
Hamden, Connecticut, United States, 06518
GSK Investigational Site
New Haven, Connecticut, United States, 06520
United States, Florida
GSK Investigational Site
Clearwater, Florida, United States, 33759
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33309
GSK Investigational Site
Juniper, Florida, United States, 33458
GSK Investigational Site
Largo, Florida, United States, 33770
GSK Investigational Site
Miami, Florida, United States, 33126
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Palm Harbor, Florida, United States, 34684
GSK Investigational Site
Pembroke Pines, Florida, United States, 33026
GSK Investigational Site
Pensacola, Florida, United States, 32514
GSK Investigational Site
Plantation, Florida, United States, 33324
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30303
GSK Investigational Site
Gainesville, Georgia, United States, 30501
United States, Idaho
GSK Investigational Site
Meridian, Idaho, United States, 83642
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60611
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Morton Grove, Illinois, United States, 60053
United States, Indiana
GSK Investigational Site
South Bend, Indiana, United States, 46601
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70719
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21286
United States, Massachusetts
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
United States, Michigan
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109-5542
GSK Investigational Site
Detroit, Michigan, United States, 48202
GSK Investigational Site
Lansing, Michigan, United States, 48917
United States, Minnesota
GSK Investigational Site
Eagan, Minnesota, United States, 55121
GSK Investigational Site
Edina, Minnesota, United States, 55435
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39216
GSK Investigational Site
Tupelo, Mississippi, United States, 38801
United States, Missouri
GSK Investigational Site
Saint Louis, Missouri, United States, 63110
GSK Investigational Site
Saint Louis, Missouri, United States, 63117
GSK Investigational Site
Saint Louis, Missouri, United States, 63132
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68198-3025
United States, Nevada
GSK Investigational Site
Henderson, Nevada, United States, 89052
United States, New Jersey
GSK Investigational Site
Camden, New Jersey, United States, 08103
GSK Investigational Site
New Brunswick, New Jersey, United States, 08901
GSK Investigational Site
Summit, New Jersey, United States, 07901
GSK Investigational Site
Teaneck, New Jersey, United States, 07666
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10461
GSK Investigational Site
Manhasset, New York, United States, 11030
GSK Investigational Site
Mineola, New York, United States, 11501
GSK Investigational Site
New York, New York, United States, 10016
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
Roslyn, New York, United States, 11576
GSK Investigational Site
Smithtown, New York, United States, 11787
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
GSK Investigational Site
Durham, North Carolina, United States, 27713
GSK Investigational Site
Greensboro, North Carolina, United States, 27408
GSK Investigational Site
New Bern, North Carolina, United States, 28562
GSK Investigational Site
Raleigh, North Carolina, United States, 27617
GSK Investigational Site
Rocky Mount, North Carolina, United States, 27804
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43203
GSK Investigational Site
Toledo, Ohio, United States, 43614
United States, Oklahoma
GSK Investigational Site
Edmond, Oklahoma, United States, 73013
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29406
GSK Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
GSK Investigational Site
Hixson, Tennessee, United States, 37343-7908
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Allen, Texas, United States, 75013
GSK Investigational Site
Houston, Texas, United States, 77004
GSK Investigational Site
Houston, Texas, United States, 77034
GSK Investigational Site
Nassau Bay, Texas, United States, 77058
GSK Investigational Site
Round Rock, Texas, United States, 78665
GSK Investigational Site
San Marcos, Texas, United States, 78666
United States, Virginia
GSK Investigational Site
Arlington, Virginia, United States, 22205-3606
GSK Investigational Site
Danville, Virginia, United States, 24541
GSK Investigational Site
Norfolk, Virginia, United States, 23502
GSK Investigational Site
Roanoke, Virginia, United States, 24016
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98133
United States, Wisconsin
GSK Investigational Site
Manitowoc, Wisconsin, United States, 54221-1450
Argentina
GSK Investigational Site
Parana, Entre Ríos, Argentina, 3103
GSK Investigational Site
Buenos Aires, Argentina, C1280AEB
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
Austria
GSK Investigational Site
Graz, Austria, 8036
GSK Investigational Site
Linz, Austria, 4021
GSK Investigational Site
Salzburg, Austria, A-5020
GSK Investigational Site
Vienna, Austria, A-1100
Belgium
GSK Investigational Site
Leuven, Belgium, 3000
Canada, Ontario
GSK Investigational Site
Mississauga, Ontario, Canada, L5M 2V8
GSK Investigational Site
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3G 1A4
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1G 2E8
Canada
GSK Investigational Site
Quebec, Canada, G1V 2L9
France
GSK Investigational Site
Bondy, France, 93140
GSK Investigational Site
Lille cedex, France, 59037
GSK Investigational Site
Parris Cedex 12, France, 75571
GSK Investigational Site
Strasbourg Cedex, France, 67098
Germany
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69121
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70376
GSK Investigational Site
Bad Nauheim, Hessen, Germany, 61231
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40225
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06120
GSK Investigational Site
Dresden, Sachsen, Germany, 01067
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
GSK Investigational Site
Jena, Thueringen, Germany, 07740
GSK Investigational Site
Elmshorn, Germany, 25335
GSK Investigational Site
Hamburg, Germany, 22767
GSK Investigational Site
Koeln, Germany, 51149
GSK Investigational Site
Leipzig, Germany, 04129
GSK Investigational Site
Puettlingen, Germany, 66346
Israel
GSK Investigational Site
Ashkelon, Israel, 78278
GSK Investigational Site
Haifa, Israel, 31048
GSK Investigational Site
Haifa, Israel, 31096
GSK Investigational Site
Jerusalem, Israel, 91120
GSK Investigational Site
Petach Tikva, Israel, 49100
GSK Investigational Site
Ramat-Gan, Israel, 52621
GSK Investigational Site
Rehovot, Israel, 76100
GSK Investigational Site
Tel-Aviv, Israel, 64239
Italy
GSK Investigational Site
Roma, Lazio, Italy, 00168
GSK Investigational Site
Milano, Lombardia, Italy, 20122
GSK Investigational Site
Milano, Lombardia, Italy, 20132
GSK Investigational Site
Milano, Lombardia, Italy, 20157
GSK Investigational Site
Pisa, Toscana, Italy, 56126
GSK Investigational Site
Padova, Veneto, Italy, 35128
GSK Investigational Site
Brescia, Italy, 25125
GSK Investigational Site
Roma, Italy, 00161
GSK Investigational Site
Siena, Italy, 53100
GSK Investigational Site
Udine, Italy, 33100
Portugal
GSK Investigational Site
Lisboa, Portugal, 1069-166
Slovakia
GSK Investigational Site
Banksa Bystrica, Slovakia, 97401
GSK Investigational Site
Bratislava, Slovakia, 826 06
GSK Investigational Site
Kosice, Slovakia, 040 11
GSK Investigational Site
Piestany, Slovakia, 921 01
Spain
GSK Investigational Site
A Coruna, Spain, 15006
GSK Investigational Site
Alicante, Spain, 03010
GSK Investigational Site
Barakaldo, Spain, 48903
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Barcelona, Spain, 08907
GSK Investigational Site
Getafe, Spain, 28905
GSK Investigational Site
Las Palmas GC, Spain, 35020
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Majadahonda, Spain, 28222
GSK Investigational Site
Murica, Spain, 30120
GSK Investigational Site
Santander, Spain, 39008
GSK Investigational Site
Sevilla, Spain, 41010
GSK Investigational Site
Toledo, Spain, 45111
GSK Investigational Site
Valencia, Spain, 46017
GSK Investigational Site
Valencia, Spain, 46026
GSK Investigational Site
Valladolid, Spain, 47005
GSK Investigational Site
Vigo/ Pontevedra, Spain, 36200
GSK Investigational Site
Vilajoyosa, Spain, 3570
Sweden
GSK Investigational Site
Stockholm, Sweden, SE-171 76
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:

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Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT01729455    
Other Study ID Numbers: 116543
HGS1006-C1124 ( Other Identifier: Human Genome Sciences Inc. )
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):
Belimumab
BENLYSTA
Systemic Lupus Erythematosus
Autoimmune Disease
Autoantibodies
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs