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.

GSK study ID
218481
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2021-16-12
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    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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