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BENLYSTA® Special Drug Use Investigation

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ClinicalTrials.gov Identifier: NCT03370263
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Drug: Benlysta

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : June 26, 2025
Estimated Study Completion Date : June 26, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab

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.




Primary Outcome Measures :
  1. Change from Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) [ Time Frame: Baseline and up to 52 weeks ]
    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.

  2. Change from Baseline in Physician's Global Assessment (PGA) score [ Time Frame: Baseline and up to 52 weeks ]
    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).

  3. Change from Baseline in Lupus Impact Tracker score [ Time Frame: Baseline and up to 52 weeks ]
    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).

  4. Number of subjects with abnormal change in laboratory parameters [ Time Frame: Baseline and up to 52 weeks ]
    Information will be collected for number of subjects with abnormal changes in laboratory parameters.

  5. Number of subjects with adverse events (AE) and serious adverse events (SAE) [ Time Frame: Up to 52 weeks ]
    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.

  6. Number of subjects with adverse drug reactions (ADR) of events defined as a priority study matter [ Time Frame: Up to 52 weeks ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370263


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
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Japan
GSK Investigational Site Recruiting
Hiroshima, Japan, 730-0001
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03370263     History of Changes
Other Study ID Numbers: 207735
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Benlysta, systemic lupus erythematosus, safety, efficacy

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs