Last updated: 11/07/2018 12:03:05

Meta-Analysis Plan for GSK1550188, 201224, Concomitant Medications Analysis

GSK study ID
201224
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: Meta-Analysis Plan for GSK1550188, 201224, Concomitant Medications Analysis
Trial description: This is a meta-analysis of the two Phase III studies BEL110751 and BEL110752. Each study was a randomized, parallel group trial with three treatment groups (Placebo, belimumab 1mg/kg, and belimumab 10 mg/kg). BEL110751 was 76 weeks in duration and BEL110752 was 52 weeks in duration. Both trials enrolled adult subjects only. All analyses will be based on the data from the belimumab 10 mg/kg and placebo treatment groups. The primary endpoint is SRI response at Week 52.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

SRI

Timeframe: 52 weeks

Secondary outcomes:

BILAG

Timeframe: By Visit

PGA Global

Timeframe: By Visit

SELENA-Sledai

Timeframe: By Visit

SRI by Visit

Timeframe: By Visit

Interventions:
  • Drug: Placebo
  • Drug: Belimumab 10 mg/kg
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Schwarting A, Dooley MA, Roth DA, Edwards L, Thompson A, Wilson B. Impact of concomitant medication use on belimumab efficacy and safety in patients with systemic lupus erythematosus. Lupus . 2016;25(14):1587-1596.
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    October 2014 to January 2015
    Type
    Observational
    Phase
    2/3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Year
    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
    Not applicable
    Actual study completion date
    2015-15-01

    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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