BENLYSTA® Special Drug Use Investigation

BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation

The objective of this study is to collect and assess the information about long-term safety and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous injection (hereinafter referred to as "Benlysta") in daily clinical practice. The aim of conducting this drug use investigation (DUI) in all subjects until data are accumulated from a certain number of subjects after Benlysta being marketed, data will be collected on safety and effectiveness of Benlysta in an early stage and thereby to take the necessary measures for proper use of Benlysta. Approximately 600 subjects will be enrolled in to this study. The observation period per subject will be 52 weeks from the start of Benlysta administration. BENLYSTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Benlysta

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan, 730-0001
    • Recruiting
    • GSK Investigational Site
    • Principal Investigator: Tetsu Oyama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will include all subjects to whom Benlysta is administered. In addition, among subjects who start administration after launch, those to whom Benlysta has already administered before the conclusion of the contract and those who has already started administration at diagnosis, because of hospital transfer, etc. will be included as well.

Description

Inclusion Criteria:

• The study will include all subjects to whom Benlysta is administered. In addition, among subjects who start administration after launch, those to whom Benlysta has already administered before the conclusion of the contract and those who has already started administration at diagnosis, because of hospital transfer, etc. will be included as well.

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Benlysta intravenous (IV); This arm will include subjects who will receive Benlysta IV. Observation period per subject will be for 52 weeks from start of Benlysta administration.	Drug: Benlysta; Benlysta will be administered intravenously or subcutaneously.
Benlysta subcutaneous (SC); This arm will include subjects who will receive BENLYSTA SC. Observation period per subject will be for 52 weeks from start of Benlysta administration.	Drug: Benlysta; Benlysta will be administered intravenously or subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI)	The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated index for assessing Systemic Lupus Erythematosus (SLE) disease activity. It is a weighted index in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed, if present at the time of the visit or in the preceding 10 days. Modified version of SLEDAI is Safety of Estrogen in Lupus National Assessment (SELENA) SLEDAI where the maximum theoretical score for the SELENA SLEDAI was 105 with 0 indicating inactive disease.	Baseline and up to 52 weeks
Change from Baseline in Physician's Global Assessment (PGA) score	The PGA is a 0 to 30 centimeters (cm) visual analogue scale (VAS). The investigator will assess the subject's global disease activity, and draw a vertical line between 0 (none) and 3 (severe) where 0 is none (no disease activity), 1 is mild, 2 is moderate and 3 is severe (worst lupus disease imaginable).	Baseline and up to 52 weeks
Change from Baseline in Lupus Impact Tracker score	The investigator will interview subjects about their conditions in the previous one month using Lupus Impact Tracker, the impact on daily living will be assessed using a 5-point scale of 0 (none of the time) to 4 (all of the time).	Baseline and up to 52 weeks
Number of subjects with abnormal change in laboratory parameters	Information will be collected for number of subjects with abnormal changes in laboratory parameters.	Baseline and up to 52 weeks
Number of subjects with adverse events (AE) and serious adverse events (SAE)	AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.	Up to 52 weeks
Number of subjects with adverse drug reactions (ADR) of events defined as a priority study matter	An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and is suspected to be related to the drug. Following will be considered as priority study matter: Serious hypersensitivity, Serious infections (including tuberculosis [TB], pneumonia, pneumocystis pneumonia [PCP], sepsis, and opportunistic infection [OI]), Reactivation of hepatitis B (HB) virus, Progressive multifocal leukoencephalopathy (PML), Interstitial pneumonitis (IP), Malignant tumor (MT), Depression and events related to suicide/self-injury.	Up to 52 weeks

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Anticipated): June 26, 2025
• Study Completion (Anticipated): June 26, 2025

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Benlysta, systemic lupus erythematosus, safety, efficacy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Belimumab
• Other Study ID Numbers: 207735

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