Last updated: 02/04/2020 17:00:12
A Meta-analysis Evaluation of Baseline Factors Which Correlate with High Baseline BLyS Levels (>2ng/mL) (BLISS-52 & BLISS 76)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A Meta-analysis Evaluation of Baseline Factors Which Correlate with High Baseline BLyS Levels (>2ng/mL) (BLISS-52 & BLISS 76)
Trial description: Post-hoc analyses from the belimumab systemic lupus erythematosus (SLE) BLISS trials (BLISS 52 and BLISS 76) demonstrated that patients with high baseline BLyS levels (>/=2ng/ml) had an increased risk of a clinically meaningful flare over 1 year. Given that BLyS levels are not routinely collected in clinical practice, further analyses were conducted to identify clinical variables that may be predictive of high BLyS levels. Furthermore, additional secondary analyses were undertaken to assess efficacy among high BLyS subjects (>/=2ng/ml) and lower BLyS subjects (< 2ng/ml).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Baseline Variables
Timeframe: Baseline
Secondary outcomes:
SELENA SLEDAI (SS)
Timeframe: 52 Weeks
SLE Responder Index (SRI)
Timeframe: 52 Weeks
Modified SLE Flare Index (First Flare)
Timeframe: 52 Weeks
Modified SLE Flare Index (Severe Flare)
Timeframe: 52 Weeks
Interventions:
Other: Placebo
Drug: Belimumab
Enrollment:
0
Observational study model:
Other
Primary completion date:
2015-11-01
Time perspective:
Retrospective
Clinical publications:
Roth D, Thompson A, Tang T, Hammer A, Molta C, Gordon D. Elevated BLyS levels in patients with systemic lupus erythematosus: associated factors and responses to belimumab. Lupus . 2016;25(4):346-354.
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
January 2014 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
2015-11-01
Actual study completion date
2015-11-01
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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