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
Study complete
Study complete
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:
Enrollment:
102
Primary completion date:
2013-15-11
Observational study model:
Cohort
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)
This study does not involve prospective enrollment of participants.
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
Study complete
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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