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BENLYSTA® Special Drug Use Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370263
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date December 6, 2017
First Posted Date December 12, 2017
Last Update Posted Date October 14, 2021
Actual Study Start Date January 15, 2018
Estimated Primary Completion Date June 26, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2017)
  • 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.
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BENLYSTA® Special Drug Use Investigation
Official Title BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Systemic Lupus Erythematosus
Intervention Drug: Benlysta
Benlysta will be administered intravenously or subcutaneously.
Study Groups/Cohorts
  • 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.
    Intervention: Drug: Benlysta
  • 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.
    Intervention: Drug: Benlysta
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 6, 2017)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 26, 2025
Estimated Primary Completion Date June 26, 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03370263
Other Study ID Numbers 207735
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2021