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)

GSK study ID
200619
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: 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
    Primary completion date:
    2015-11-01
    Observational study model:
    Other
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    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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