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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
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.
- Prevalence/Incidence Study:
- Prevalent SLE patient:
- Prevalence/Incidence Study and Standard of Care Study:
- Miscoded diagnoses and drug-induced lupus
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of SLE (according to ACR criteria or clinical judgment) before 31 Dec 2010;
- Resident in the target city/ region on 31 Dec 2010 according to clinical records;
- Were alive on 31 Dec 2010 (not deceased) according to clinical records. Incident SLE patient:
- New diagnosis of SLE (according to ACR criteria or clinical judgement) between 1 Jan 2010 and 31 Dec 2010;
- Resident in the target city/ region at date of diagnosis in 2010 according to clinical records. Note: Those meeting the Incident SLE patient criteria may also meet the Prevalent SLE patient criteria if resident and alive on 31 Dec 2010 Standard of Care Study:
- Age ≥ 18 before 01 Jan 2010;
- Patient’s or patient’s representative’s verbal voluntary informed consent (see Section 7.1);
- Established diagnosis of SLE (according to ACR criteria or clinical judgment) before 31 Dec 2010;
- At least one visit to the investigational center, inpatient or outpatient, recorded in medical documentation from 01 Jan 2010 to 31 Dec 2010;
- Investigational center is patient’s primary place for SLE care
- Autoantibody positive disease (ANA and/or anti-ds-DNA positive test) at or prior to the last clinic visit in 2010
- Resident in or outside the target city/ region for any period in 2010 according to clinical records.
- Not involved in any clinical trial in the period from 01 Jan 2010 to 31 Dec 2010
Prevalence/Incidence Study: Prevalent SLE patient:
Exclusion criteria:
- Miscoded diagnoses and drug-induced lupus
Prevalence/Incidence Study and Standard of Care Study:
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