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

Systemic Lupus Erythematosus Clinical Trial

— SABLE  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01729455
• Other study ID #: 116543
• Secondary ID: HGS1006-C1124
• Status: Active, not recruiting
• Start date: February 21, 2013
• Est. completion date: February 17, 2025

Study information

• Verified date: January 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3138
• Est. completion date: February 17, 2025
• Est. primary completion date: February 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• BENLYSTA
As prescribed. Belimumab is a recombinant, human, IgG1? monoclonal antibody for the treatment of systemic lupus erythematosus.

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.

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma Buenos Aires
Argentina	GSK Investigational Site	Parana	Entre Ríos
Austria	GSK Investigational Site	Graz
Austria	GSK Investigational Site	Linz
Austria	GSK Investigational Site	Salzburg
Austria	GSK Investigational Site	Vienna
Belgium	GSK Investigational Site	Leuven
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
France	GSK Investigational Site	Bondy
France	GSK Investigational Site	Lille cedex
France	GSK Investigational Site	Parris Cedex 12
France	GSK Investigational Site	Strasbourg Cedex
Germany	GSK Investigational Site	Bad Bramstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Bad Nauheim	Hessen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Elmshorn
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Jena	Thueringen
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Koeln
Germany	GSK Investigational Site	Leipzig
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Puettlingen
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Israel	GSK Investigational Site	Ashkelon
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Nahariya
Israel	GSK Investigational Site	Petach Tikva
Israel	GSK Investigational Site	Ramat-Gan
Israel	GSK Investigational Site	Rehovot
Israel	GSK Investigational Site	Tel-Aviv
Italy	GSK Investigational Site	Brescia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Siena
Italy	GSK Investigational Site	Udine
Portugal	GSK Investigational Site	Lisboa
Slovakia	GSK Investigational Site	Banksa Bystrica
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Piestany
Spain	GSK Investigational Site	A Coruna
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Barakaldo
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Getafe
Spain	GSK Investigational Site	Las Palmas GC
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Majadahonda
Spain	GSK Investigational Site	Murica
Spain	GSK Investigational Site	Santander
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Toledo
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valladolid
Spain	GSK Investigational Site	Vigo/ Pontevedra
Spain	GSK Investigational Site	Vilajoyosa
Sweden	GSK Investigational Site	Stockholm
United States	GSK Investigational Site	Allen	Texas
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Arlington	Virginia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Brandon	Florida
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Camden	New Jersey
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Danbury	Connecticut
United States	GSK Investigational Site	Danville	Virginia
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Duncansville	Pennsylvania
United States	GSK Investigational Site	Eagan	Minnesota
United States	GSK Investigational Site	Edina	Minnesota
United States	GSK Investigational Site	Edmond	Oklahoma
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Gainesville	Georgia
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Glendale	California
United States	GSK Investigational Site	Goodyear	Arizona
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Hamden	Connecticut
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Hixson	Tennessee
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Juniper	Florida
United States	GSK Investigational Site	La Mesa	California
United States	GSK Investigational Site	Lakewood	California
United States	GSK Investigational Site	Lansing	Michigan
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	Loma Linda	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Manhasset	New York
United States	GSK Investigational Site	Manitowoc	Wisconsin
United States	GSK Investigational Site	Meridian	Idaho
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Mineola	New York
United States	GSK Investigational Site	Morton Grove	Illinois
United States	GSK Investigational Site	Murrieta	California
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Nassau Bay	Texas
United States	GSK Investigational Site	New Bern	North Carolina
United States	GSK Investigational Site	New Haven	Connecticut
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Palm Harbor	Florida
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plantation	Florida
United States	GSK Investigational Site	Pomona	California
United States	GSK Investigational Site	Prescott	Arizona
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Roanoke	Virginia
United States	GSK Investigational Site	Rocky Mount	North Carolina
United States	GSK Investigational Site	Roslyn	New York
United States	GSK Investigational Site	Round Rock	Texas
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	San Marcos	Texas
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Smithtown	New York
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	Summit	New Jersey
United States	GSK Investigational Site	SunCity	Arizona
United States	GSK Investigational Site	Teaneck	New Jersey
United States	GSK Investigational Site	The Woodlands	Texas
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Tupelo	Mississippi
United States	GSK Investigational Site	Upland	California
United States	GSK Investigational Site	West Hills	California
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Canada,  France,  Germany,  Israel,  Italy,  Portugal,  Slovakia,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with organ damage	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
Other	Number of participants with use of concomitant SLE medications	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
Other	Number of participants with hospitalizations	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
Primary	Number of participants with AESI	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