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

January 23, 2023 updated by: GlaxoSmithKline

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 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • GSK Investigational Site
      • Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
        • GSK Investigational Site
    • Entre Ríos
      • Parana, Entre Ríos, Argentina, 3103
        • GSK Investigational Site
  • Austria
      • Graz, Austria, 8036
        • GSK Investigational Site
      • Linz, Austria, 4021
        • GSK Investigational Site
      • Salzburg, Austria, A-5020
        • GSK Investigational Site
      • Vienna, Austria, A-1100
        • GSK Investigational Site
  • Belgium
      • Leuven, Belgium, 3000
        • GSK Investigational Site
  • Canada
      • Quebec, Canada, G1V 2L9
        • GSK Investigational Site
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2V8
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5T 2S8
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • GSK Investigational Site
  • France
      • 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
        • GSK Investigational Site
  • Germany
      • 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
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69121
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Germany, 70376
        • GSK Investigational Site
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Duesseldorf, Nordrhein-Westfalen, Germany, 40225
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01067
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • GSK Investigational Site
    • Schleswig-Holstein
      • 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
    • Thueringen
      • Jena, Thueringen, Germany, 07740
        • GSK Investigational Site
  • Israel
      • Ashkelon, Israel, 78278
        • GSK Investigational Site
      • Haifa, Israel, 31096
        • GSK Investigational Site
      • Haifa, Israel, 31048
        • GSK Investigational Site
      • Jerusalem, Israel, 91120
        • GSK Investigational Site
      • Nahariya, Israel, 22100
        • 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
        • GSK Investigational Site
  • Italy
      • Brescia, Italy, 25125
        • GSK Investigational Site
      • Siena, Italy, 53100
        • GSK Investigational Site
      • Udine, Italy, 33100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00168
        • GSK Investigational Site
      • Roma, Lazio, Italy, 00161
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20157
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20122
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • GSK Investigational Site
    • Veneto
      • Padova, Veneto, Italy, 35128
        • GSK Investigational Site
  • Portugal
      • Lisboa, Portugal, 1069-166
        • GSK Investigational Site
  • Slovakia
      • 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
        • GSK Investigational Site
  • Spain
      • 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, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28007
        • 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, 47012
        • GSK Investigational Site
      • Vigo/ Pontevedra, Spain, 36200
        • GSK Investigational Site
      • Vilajoyosa, Spain, 3570
        • GSK Investigational Site
  • Sweden
      • Stockholm, Sweden, SE-171 76
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • GSK Investigational Site
    • Arizona
      • 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
      • Prescott, Arizona, United States, 86305
        • GSK Investigational Site
      • SunCity, Arizona, United States, 85351
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85712
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85704
        • GSK Investigational Site
    • California
      • 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, 90095
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
      • Los Angeles, California, United States, 90033
        • 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
        • GSK Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • GSK Investigational Site
      • Hamden, Connecticut, United States, 06518
        • GSK Investigational Site
      • New Haven, Connecticut, United States, 06520
        • GSK Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • 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, 33136
        • GSK Investigational Site
      • Miami, Florida, United States, 33126
        • 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
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • GSK Investigational Site
      • Gainesville, Georgia, United States, 30501
        • GSK Investigational Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60612
        • GSK Investigational Site
      • Morton Grove, Illinois, United States, 60053
        • GSK Investigational Site
    • Indiana
      • South Bend, Indiana, United States, 46601
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70719
        • GSK Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21286
        • GSK Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • GSK Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5542
        • GSK Investigational Site
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
      • Lansing, Michigan, United States, 48917
        • GSK Investigational Site
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • GSK Investigational Site
      • Edina, Minnesota, United States, 55435
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • GSK Investigational Site
      • Tupelo, Mississippi, United States, 38801
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • GSK Investigational Site
      • Saint Louis, Missouri, United States, 63117
        • GSK Investigational Site
      • Saint Louis, Missouri, United States, 63132
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • GSK Investigational Site
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • GSK Investigational Site
      • Summit, New Jersey, United States, 07901
        • GSK Investigational Site
      • Teaneck, New Jersey, United States, 07666
        • GSK Investigational Site
    • New York
      • 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, 10021
        • GSK Investigational Site
      • New York, New York, United States, 10016
        • GSK Investigational Site
      • Roslyn, New York, United States, 11576
        • GSK Investigational Site
      • Smithtown, New York, United States, 11787
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28204
        • GSK Investigational Site
      • Greensboro, North Carolina, United States, 27405
        • 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
        • GSK Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43203
        • GSK Investigational Site
      • Toledo, Ohio, United States, 43614
        • GSK Investigational Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, United States, 73103
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, United States, 73104
        • GSK Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • GSK Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • GSK Investigational Site
      • Charleston, South Carolina, United States, 29406
        • GSK Investigational Site
    • Tennessee
      • Hixson, Tennessee, United States, 37343-7908
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
    • Texas
      • 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
        • GSK Investigational Site
      • The Woodlands, Texas, United States, 77382
        • GSK Investigational Site
    • Virginia
      • 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
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98133
        • GSK Investigational Site
    • Wisconsin
      • Manitowoc, Wisconsin, United States, 54221-1450
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with active autoantibody-positive SLE.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years
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).
Up to 5 years
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.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2013

Primary Completion (Anticipated)

February 17, 2025

Study Completion (Anticipated)

February 17, 2025

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116543
  • HGS1006-C1124 (Other Identifier: Human Genome Sciences Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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