Last updated: 02/04/2020 14:40:15

Study 201223 - Interim Meta-analysis of BEL112233, BEL112234, BEL110751 and BEL110752

GSK study ID
201223
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: Study 201223 - Interim Meta-analysis of BEL112233, BEL112234, BEL110751 and BEL110752
Trial description: Study 201223 is a pooled Analysis of BEL112233 and BEL112234, long term extension studies of BEL110751 (BLISS 76) and BEL110752 (BLISS 52), for the treatment of Systemic Lupus Erythematosus (SLE). The purpose of this interim reporting effort is to pool these datasets to assess the long term safety and SDI scores of subjects treated with belimumab plus standard care in SLE patients .
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

the change in SDI from baseline to the 5-6 year interval of belimumab treatment

Timeframe: year 5-6

Secondary outcomes:

Time to First SDI Worsening

Timeframe: any

Transition Analysis (multi-state modelling) ) to explore transitions in SDI scores, including covariate analysis

Timeframe: any

Interventions:
  • Drug: belimumab
    • Enrollment:
    0
    Primary completion date:
    2014-15-12
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Bruce I, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D. Long-term Organ Damage Accrual and Safety in Patients with SLE Treated with Belimumab Plus Standard of Care. Lupus. 2016;25(7):699-709
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    April 2014 to December 2014
    Type
    Observational
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • n/a
    • n/a
    • There were no specific inclusion or exclusion criteria - patients were required to have entered the long-term extension stduies BEL112233 or BEL112234
    Inclusion and exclusion criteria
    Inclusion criteria:
    • n/a
    Exclusion criteria:
    • n/a There were no specific inclusion or exclusion criteria
    • patients were required to have entered the long-term extension stduies BEL112233 or BEL112234

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    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
    2014-15-12
    Actual study completion date
    2014-15-12

    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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