Evaluation of use of belimumab in clinical practice settings: Observations from SwitzerlandOBSErve
Trial overview
Overall clinical response and assessment of specific SLE anifestations at 6 months of therapy based on a PGA-like scale
Timeframe: 6 months
Change in the SELENA-SLEDAI score, treatment patterns with concomitant medication, particularly steroids and reasons for discontinuation after 6 months of therapy
Timeframe: 6 months
Participation criteria
- Patient Inclusion Criteria: •Signed patient informed consent form available at time of inclusion •Diagnosed with SLE •Adults ≥ 18 years •Initial prescription of belimumab by treating physician as part of standard care (belimumab naïve patients) •Treatment with belimumab was initiated at least 6 months before time of inclusion into the study •Patient received at least one dose of belimumab •Reason for belimumab initiation can be identified •For those who discontinued belimumab, reason for discontinuation can be identified •Physician is able to report treatment outcomes at defined time periods (e.g. at 6 months post-index date or at time of discontinuation) •Medical history must be available for chart abstraction as defined by the study period Patient
- Currently enrolled in a SLE-related clinical trial •Started Belimumab as part of a clinical trial in an interventional arm Physician Inclusion Criteria: •Must have managed at least 5 SLE patients •Must be treating SLE patients for at least 5 years •Must have treated at least 2 patients with belimumab as part of standard care and currently have at least 1 patient on belimumab (as part of usual care) •Must agree to the requirements of the study protocol including resolution of data validation queries
- Exclusion Criteria:
Patient Inclusion Criteria: •Signed patient informed consent form available at time of inclusion •Diagnosed with SLE •Adults ≥ 18 years •Initial prescription of belimumab by treating physician as part of standard care (belimumab naïve patients) •Treatment with belimumab was initiated at least 6 months before time of inclusion into the study •Patient received at least one dose of belimumab •Reason for belimumab initiation can be identified •For those who discontinued belimumab, reason for discontinuation can be identified •Physician is able to report treatment outcomes at defined time periods (e.g. at 6 months post-index date or at time of discontinuation) •Medical history must be available for chart abstraction as defined by the study period Patient
•Currently enrolled in a SLE-related clinical trial •Started Belimumab as part of a clinical trial in an interventional arm Physician Inclusion Criteria: •Must have managed at least 5 SLE patients •Must be treating SLE patients for at least 5 years •Must have treated at least 2 patients with belimumab as part of standard care and currently have at least 1 patient on belimumab (as part of usual care) •Must agree to the requirements of the study protocol including resolution of data validation queries Exclusion Criteria: -
Trial location(s)
No location data available.
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.