Last updated: 07/21/2020 17:30:05

Evaluation of use of belimumab in clinical practice settings: Observations from SwitzerlandOBSErve

GSK study ID
201232
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluation of use of belimumab in clinical practice settings: Observations from Switzerland
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 Switzerland.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Overall clinical response and assessment of specific SLE anifestations at 6 months of therapy based on a PGA-like scale

Timeframe: 6 months

Secondary outcomes:

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

Interventions:
  • Drug: Belimumab
    • Enrollment:
    40
    Primary completion date:
    2017-13-02
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Johannes von Kempis, Sabine Duetsch, Nicola Reuschling, Rahel Villiger, Peter M Villiger, Florence Vallelian, Dominik J Schaer, Ruediger B Mueller. Clinical outcomes in patients with systemic lupus erythematosus treated with belimumab in clinical practice settings: a retrospective analysis of results from the OBSErve study in Switzerland. Swiss Med Wkly. 2019;149:w20022 DOI: 10.4414/smw.2019.20022 PMID: 30852830
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Kantar Health GmbH, Munchen, Germany
    Study date(s)
    November 2014 to February 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 90 Year
    Accepts healthy volunteers
    none
    • 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:
    Inclusion and exclusion criteria
    Inclusion 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

    Exclusion criteria:

      •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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    Study complete
    Actual primary completion date
    2017-13-02
    Actual study completion date
    2017-13-02

    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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