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.
Brief Title
Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
Categories
Completion Date
Completion Date Type
Actual
Conditions
Systemic Lupus Erythematosus
Eligibility 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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Belimumab
BENLYSTA
Systemic Lupus Erythematosus
Autoimmune Disease
Autoantibodies
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01729455
Org Class
Industry
Org Full Name
GlaxoSmithKline
Org Study Id
116543
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Description
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.
Outcome Measure
Number of participants with AESI
Outcome Time Frame
Up to 5 years
Secondary Ids
Secondary Id
HGS1006-C1124
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Participants with active autoantibody-positive SLE.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Chaim Putterman
Investigator Email
chaim.putterman@einsteinmed.org
Investigator Phone
718-430-4266