Last updated: 05/21/2020 20:20:12
Efficacy analysis of SLE patients treated with Benlysta in studies BEL110751 and BEL110752 investigating BLyS mRNA levels and Type 1 Interferon Inducible Gene Signature Status
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Efficacy analysis of SLE patients treated with Benlysta in studies BEL110751 and BEL110752 investigating BLyS mRNA levels and Type 1 Interferon Inducible Gene Signature Status
Trial description: SLE is a chronic autoimmune disorder characterized by autoantibody production and abnormal B lymphocyte function. This study will investigate the efficacy of belimumab 10 milligram per kilogram (mg/kg) compared with placebo in subjects with SLE in studies BEL110571 and BEL110572 to investigate B Lymphocyte Stimulator (BLyS) Messenger Ribonucleic Acid (mRNA) levels (High or Medium or Low) and Type 1 Interferon Inducible Gene Signature Status (High or Low) at Baseline. Data from two Phase 3 intravenous (IV) studies, BEL110751 and BEL110752 will be used. BENLYSTA™ is a registered trademark of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
SLE Responder Index (SRI) response over 52 weeks
Timeframe: 52 weeks
Correlation between BLyS mRNA levels and Baseline Interferon Signature levels
Timeframe: Baseline and up to 52 weeks
Secondary outcomes:
SRI response over time
Timeframe: Week 52
Time to first severe flare
Timeframe: 52 Weeks
Alternative thresholds of SRI response
Timeframe: Week 52
More extreme SELENA-SLEDAI response
Timeframe: Week 52
Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2018-24-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Christel Wilkinson, Robert Henderson, Angela R Jones-Leone, Shaun Flint, Mark Lennon, Roger A Levy, Beulah Ji, Damon L Bass, David Roth. The role of baseline BLyS levels and type 1 interferon inducible gene signature status in determining belimumab response in systemic lupus erythematosus: a post hoc meta-analysis. Arthritis Res Ther. 2020;22(1):102
DOI: 10.1186/s13075-020-02177-0
PMID: 32366280
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
January 2018 to April 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
45 - 65 Years
Accepts healthy volunteers
Not applicable
- N/A
Inclusion and exclusion criteria
Inclusion criteria:
- N/A
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
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
Study complete
Actual primary completion date
2018-24-04
Actual study completion date
2018-24-04
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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