Last updated: 11/07/2018 10:24:50

Epidemiological multinational (Russia, Ukraine and Kazakhstan), retrospective observational study to evaluate medical, economic and social factors in patients with systemic lupus erythematosus in heading rheumatologic centersESSENCE

GSK study ID
116387
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: Epidemiological multinational (Russia, Ukraine and Kazakhstan), retrospective observational study to evaluate medical, economic and social factors in patients with systemic lupus erythematosus in heading rheumatologic centers
Trial description: The study is a non-interventional, multinational, multi-centre, retrospective study carried out in 3 countries (Russia, Ukraine, and Kazakhstan) in specialized rheumatology centres. The study will estimate the local incidence and prevalence of Systemic Lupus Erythematosus (SLE) in Russian, Ukrainian, and Kazakh selected heading rheumatology centres within the year 2010, describe a “real-life” standard of care (SoC) and resources utilized related to SLE in these countries. The retrospective data will be collected from the medical records at the first visit to the centres and for a period from 01 Jan to 31 Dec 2010. At least 400 patients (200 patients in Russia, 100 in Ukraine, and 100 in Kazakhstan) will be enrolled in the study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Cumulative Incidence and Prevalence of adult patients with SLE in Ukrainian, Russian and Kazakh selected regions/cities

Timeframe: between 1 Jan 2010 and 31 Dec 2010

Secondary outcomes:

Clinical SLE characteristics (organ damage, disease activity, laboratory tests)

Timeframe: between 1 Jan 2010 and 31 Dec 2010

Healthcare utilisation – number of clinic visits (emergency room visits, hospitalisations, out-patient visits) in 2010

Timeframe: between 1 Jan 2010 and 31 Dec 2010

Total direct medical cost for adult SLE patients

Timeframe: between 1 Jan 2010 and 31 Dec 2010

Cost per flare (overall and by flare severity) for adult SLE patients

Timeframe: between 1 Jan 2010 and 31 Dec 2010

Baseline characteristics (social and demographic, medical history) of study population

Timeframe: between 1 Jan 2010 and 31 Dec 2010

Proportion of patients by treatment regimen

Timeframe: between 1 Jan 2010 and 31 Dec 2010

Interventions:
  • Other: Patient records review
  • Enrollment:
    531
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Nasonov E, Soloviev S, Davidson J, Lila A, Ivanova R, Togizbayev G, BaimukhambetovC, Shevchuk S, Iaremenko O, Gnylorybov A, SmailovaA, Tchernogolov V, Malynovska K, Vasylyev A, Horacio MHS. The prevalence and incidence of Systemic Lupus Erythematosus (SLE) in selected cities from three Commonwealth of Independent States countries (the Russian Federation, Ukraine and Kazakhstan). Lupus.
    Medical condition
    Systemic Lupus Erythematosus
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    March 2012 to April 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 100 Year
    Accepts healthy volunteers
    none
    • Prevalence/Incidence Study:
    • Prevalent SLE patient:
    • Prevalence/Incidence Study and Standard of Care Study:
    • Miscoded diagnoses and drug-induced lupus

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    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
    Not applicable
    Actual study completion date
    2012-23-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website