Last updated: 01/29/2025 11:00:20
Analysis of Systemic Lupus Erythematosus (SLE) polygenic risk scores on GSK1550188 efficacy in SLE patients in three Phase III belimumab clinical trials.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Gx218481_Exploratory Gx analysis of SLE polygenic risk scores on GSK1550188 efficacy in SLE patients in three Phase III belimumab clinical trials (BEL110752, BEL112341 and BEL115471).
Trial description: This study assesses the effect of SLE polygenic risk scores on response to belimumab in subjects with Systemic Lupus Erythematosus in studies BEL110751, BEL110752, BEL112341.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Systemic Lupus Responder Index (SRI) measured at week 52
Timeframe: 52 weeks
Change from baseline in SELENA SLEDAI scores by visit up to week 52
Timeframe: 52 weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: Belimumab
Drug: Placebo
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2021-16-12
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
December 2021 to December 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- In the ITT populations of BEL110751, BEL110752, BEL112341 AND
- Received at least one dose of placebo or belimumab AND
- Not in the ITT populations of BEL110751, BEL110752, BEL112341
- OR
Inclusion and exclusion criteria
Inclusion criteria:
- In the ITT populations of BEL110751, BEL110752, BEL112341 AND
- Received at least one dose of placebo or belimumab AND
- Provided written informed consent for genetics research, a DNA sample, and were successfully genotyped.
Exclusion criteria:
- Not in the ITT populations of BEL110751, BEL110752, BEL112341 OR
- Did not receive at least one dose of placebo or belimumab OR
- Did not provide written informed consent for genetics research, a DNA sample, or were not successfully genotyped.
Trial location(s)
No location data available.
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
Finalized
Actual primary completion date
2021-16-12
Actual study completion date
2021-16-12
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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