Last updated: 03/10/2020 14:40:08
An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of Benlysta administered in Korean subjects with SLEBenlysta PMS
GSK study ID
202024
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of Benlysta administered in Korean subjects with SLE
Trial description: Benlysta is approved in U.S, Canada and Europe for therapy of SLE, and has been approved in 21, June, 2013 in Korea. We aimed to conduct PMS to monitor the safety and effectiveness based on the data collected in real world clinical practice according to PMS regulation.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
to monitor all (S)AEs and ADRs
Timeframe: at least 28 days
Secondary outcomes:
to monitor effectiveness after administrating Benlysta, as determined by Physician’s Global Assessment (PGA; mandatory at baseline and 1 year post-Benlysta treatment) or change in steroid dose from baseline to 1 year after first dose of Benlysta.
Timeframe: baseline and at least 1 year
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-27-07
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
December 2019 to July 2020
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
19+ years
Accepts healthy volunteers
none
- Adult subjects who have positive auto-antibody, active Systemic Lupus Erythematosus, and are receiving SLE standard therapy
- Subjects who will administer (new users) or are administering (current users) Benlysta according to locally approved prescribing information
- Subjects who have a history of anaphylaxis for ingredients of this medicine
- Subjects who have active infection
Inclusion and exclusion criteria
Inclusion criteria:
- Adult subjects who have positive auto-antibody, active Systemic Lupus Erythematosus, and are receiving SLE standard therapy Subjects who will administer (new users) or are administering (current users) Benlysta according to locally approved prescribing information
Exclusion criteria:
- Subjects who have a history of anaphylaxis for ingredients of this medicine Subjects who have active infection
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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