Last updated: 11/07/2018 11:29:47

EVALUATION OF USE OF BELIMUMAB IN CLINICAL PRACTICE SETTINGS (OBSERVE): OBSERVATIONS FROM CANADAOBSERVE Canada

GSK study ID
117300
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 (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
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    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:

      Diagnosed with SLE

      • 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
    Exclusion criteria:

      Currently enrolled in an SLE-related clinical trial

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website