Last updated: 02/04/2020 15:50:06

A retrospective data collection of the parameters required as per Belgian reimbursement criteria in SLE patients having received belimumab

GSK study ID
201539
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 retrospective data collection of the parameters required as per Belgian reimbursement criteria in SLE patients having received belimumab
Trial description: Retrospective data collection carried out to comply with the requirements of the article 81 Convention between GSK and RIZIV/INAMI.
The data collection includes SLE patients in Belgium treated with belimumab.
Specific clinical data relating to the medical records of patients will be collected from start of belimumab treatment till the most recent available follow-up visit. The study covers the period from the beginning of availability of belimumab in Belgium in August 2012 until early 2015 in order for the data to be available for the report in support of the renewal of belimumab article 81 Convention.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

• % patients continuing belimumab treatment after 6 months

Timeframe: up to 3 years

Secondary outcomes:
Not applicable
Interventions:
  • Drug: belimumab
    • Enrollment:
    0
    Primary completion date:
    2015-30-04
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    April 2014 to April 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • This study will include a maximal number of all Belgian patients who have been prescribed belimumab for an active autoantibody-positive SLE with a high degree of disease activity as further specified by the Belgian reimbursement criteria
    Inclusion and exclusion criteria
    Inclusion criteria:
    • This study will include a maximal number of all Belgian patients who have been prescribed belimumab for an active autoantibody-positive SLE with a high degree of disease activity as further specified by the Belgian reimbursement criteria

    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
    2015-30-04
    Actual study completion date
    2015-30-04

    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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