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
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2015-30-04
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)

No location data available.

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
Finalized
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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