Last updated: 02/03/2020 18:10:16
Evaluation Of Use of Belimumab in Clinical Practice SEttings (OBSErve) - Observations from GermanyOBSErve
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 Germany
Trial description: The purpose of the study is to describe the overall patterns of Systemic Lupus Erythematosus (SLE) care and outcomes among belimumab users in clinical practices in Germany.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall clinical response to 6-months of belimumab treatment reported as % of patients with specific levels of clinical improvement
Timeframe: At Day 0
Secondary outcomes:
% of physicians routinely using different laboratory measures as part of regular SLE management
Timeframe: At Day 0
% of physicians routinely using different disease activity instruments as part of regular SLE management
Timeframe: At Day 0
Interventions:
Other: Belimumab outcomes
Enrollment:
102
Observational study model:
Cohort
Primary completion date:
2013-15-11
Time perspective:
Retrospective
Clinical publications:
Andreas Schwarting, Johann O Schroeder, Tobias Alexander, Marc Schmalzing, Christoph Fiehn, Christof Specker, Alessandra Perna, Constanze Cholmakow-Bodechtel, Volker B Koscielny, Heike Carnarius. First real-world insights into belimumab use and outcomes in routine clinical care of systemic lupus erythematosus in Germany: Results from the OBSErve Germany study. Rheumatol Ther. 2016;3(2):271-290.
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Kantar Health GmbH, Munchen, Germany
Study date(s)
April 2013 to November 2013
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Patient Inclusion Criteria:
- Diagnosed with SLE
Inclusion and exclusion criteria
Inclusion criteria:
- Patient Inclusion Criteria:
- Diagnosed with SLE
- Adults >= 18 years old
- Prescribed belimumab by treating physician as part of usual care
- At point/ time of survey the patient has prescribed belimumab for at least 6 months
- 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)
- Medical history must be available for chart abstraction as defined by the study period Patient Exclusion Criteria:
- Currently enrolled in an SLE-related clinical trial
- Started belimumab as part of a clinical trial Physician Inclusion Criteria:
- Must currently manage and /or treat at least 10 SLE patients
- Must be treating SLE for at least 5 years
- Must have treated at least 2 patients with belimumab as part of usual care and currently have at least 1 patients on belimumab (as part of usual care)
- Must agree to all rules of the study including resolution of data validation queries
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
2013-15-11
Actual study completion date
2013-15-11
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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