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

Active, not recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: BENLYSTA; Other: SLE treatment

• Registration Number: NCT01729455
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-20
• Study Start: 2013-02-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3138

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BENLYSTA cohort	BENLYSTA	Participants with active, autoantibody-positive SLE treated with BENLYSTA at Baseline.
BENLYSTA cohort	SLE treatment	Participants with active, autoantibody-positive SLE treated with BENLYSTA at Baseline.
Comparison cohort	SLE treatment	Participants with active, autoantibody-positive SLE treated without BENLYSTA at Baseline.

Primary Outcome Measures

Name	Time	Method
Number of participants with AESI	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇪 Stockholm, Sweden