Last updated: 02/04/2020 17:00:24
Belimumab 10mg/kg versus Placebo Post-hoc Analysis of Corticosteroid Use across 52 Weeks of Treament (BLISS-52 & BLISS-76 Meta-analysis)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Belimumab 10mg/kg versus Placebo Post-hoc Analysis of Corticosteroid Use across 52 Weeks of Treament (BLISS-52 & BLISS-76 Meta-analysis)
Trial description: Previous belimumab analyses have been conducted to evaluate corticosteroid use in BLISS 52 & BLISS 76 (pivotal studies); however to date analyses have mostly focused on corticosteroid changes observed at Week 52. Further pooled post-hoc (BLISS 52 & BLISS 76) analyses were thus undertaken to evaluate changes in cumulative corticosteroid doses observed throughout the BLISS studies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Net cumulative change from baseline in prednisone dose
Timeframe: Day 0 to Day 364
Secondary outcomes:
Cumulative decrease in prednisone dose
Timeframe: Day 0 to Day 364
Change from baseline in average daily prednisone dose
Timeframe: Day 0 to Day 364
Cumulative increase in prednisone dose
Timeframe: Day 0 to Day 364
Interventions:
Vaccine: Belimumab
Other: Placebo
Enrollment:
0
Observational study model:
Other
Primary completion date:
2015-10-01
Time perspective:
Retrospective
Clinical publications:
van Vollenhoven R, Petri M, Wallace D, Roth D, Molta C, Hammer A, Tang Y, Thompson A . Cumulative Corticosteroid Dose Over Fifty-Two Weeks in Patients With Systemic Lupus Erythematosus: Pooled Analyses From the Phase III Belimumab Trials. Arthritis Rheum. 2016;68(9):2184-2192.
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
December 2013 to January 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- N/A
- N/A
Inclusion and exclusion criteria
Inclusion criteria:
- N/A
Exclusion criteria:
- N/A
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2015-10-01
Actual study completion date
2015-10-01
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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