Last updated: 01/16/2023 10:50:23

Evaluation Of Use of Belimumab in Clinical Practice SEttings (OBSErve) Observations from SpainOBSErve Spain

GSK study ID
200883
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 Spain
Trial description: The OBSErve Spain study (Evaluation Of Use of Belimumab in Clinical Practice SEttings [OBSErve] Observations from Spain) aimed to describe the patterns of SLE care and clinical benefit assessment modalities among belimumab users on a 6-months period in clinical practices in Spain
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Disease activity

Timeframe: 6 Months

Secondary outcomes:

Corticosteroids Daily Use

Timeframe: 6 Months

ER Visits

Timeframe: 6 Months

Open Question

Timeframe: 6 Months

SELENA-SLEDAI Index

Timeframe: 6 Months

Time of Diagnosis

Timeframe: 6 Months

Interventions:
  • Drug: Belilumab i.v.
    • Enrollment:
    64
    Primary completion date:
    2014-30-04
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Josefina Cortes-Hernandez, Carlos Marras Fernández-Cid , Jose Luis Andreu Sánchez , Jaime Calvo Alén, Angel M. García-Aparicio , Elvira Díez Álvarez , Francisco Javier Hidalgo Bermejo, Carlos Coronell , Alessandra Perna , Josep Ordi Ros .Reduction of disease activity, corticosteroids use, and healthcare resource utilisation in patients with systemic lupus erythematosus treated with belimumab in clinical practice settings: OBSErve Spain multicentre study.Reumatol Clin.2022; DOI: NULL PMID: NULL
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    December 2013 to April 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 120 Year
    Accepts healthy volunteers
    none
    • Patient charts will be selected for data abstraction by Rheumatologists/Internal Medicine Physicians and will be determined eligible for study enrollment based on the following inclusion criteria:
    • Diagnosed with SLE
    • Patient charts will be selected for data abstraction by physicians and will be determined ineligible for study enrollment based on the following exclusion criterion:
    • Currently enrolled in an SLE-related clinical trial
    Inclusion and exclusion criteria
    Inclusion criteria:

      Patient charts will be selected for data abstraction by Rheumatologists/Internal Medicine Physicians and will be determined eligible for study enrollment based on the following inclusion criteria:

      • Diagnosed with SLE
      • Adults ≥ 18 years old
      • Initial prescription of belimumab by treating physician as part of usual care (belimumab naïve patients)
      • 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
    Exclusion criteria:

      Patient charts will be selected for data abstraction by physicians and will be determined ineligible for study enrollment based on the following exclusion criterion:

      • Currently enrolled in an SLE-related clinical trial
      • Started Belimumab as part of a clinical trial in an interventional arm

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Study report synopsis
    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
    2014-30-04
    Actual study completion date
    2014-30-04

    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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