Last updated: 11/07/2018 11:29:47
EVALUATION OF USE OF BELIMUMAB IN CLINICAL PRACTICE SETTINGS (OBSERVE): OBSERVATIONS FROM CANADAOBSERVE Canada
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: EVALUATION OF USE OF BELIMUMAB IN CLINICAL PRACTICE SETTINGS (OBSERVE): OBSERVATIONS FROM CANADA
Trial description: This is a retrospective chart review study to evaluate the use of belimumab after 6 months of therapy in Canadian clinical practice setting.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
clinical response
Timeframe: 6 months
Secondary outcomes:
resource utilization
Timeframe: 6 months
quality of life
Timeframe: 6 months
concomitant medications
Timeframe: 6 months
disease activity instruments
Timeframe: 6 months
Interventions:
Drug: belimumab
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Zahi Touma, Amyn Sayani, Christian Pineau, Isabelle Fortin, Mark Matsos, George A. Ecker, Andrew Chow, Sandra Iczkovitz. Belimumab use, clinical outcomes and glucocorticoid reduction in patients with systemic lupus erythematosus receiving belimumab in clinical practice settings: results from the OBSErve Canada study. Rheumatol Int. 2017;37(6):865-73
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
February 2013 to February 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Diagnosed with SLE
- Adults ≥ 18 years old
- Currently enrolled in an SLE-related clinical trial
Inclusion and exclusion criteria
Inclusion criteria:
- Adults ≥ 18 years old
- Prescribed belimumab by treating physician as part of usual care
- Received at least 8 belimumab infusions
- Reason for belimumab initiation can be identified
- Medical history must be available for chart abstraction as defined by the study period
Diagnosed with SLE
Exclusion criteria:
Currently enrolled in an SLE-related clinical trial
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
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
Not applicable
Actual study completion date
2015-02-02
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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