Last updated: 11/03/2018 17:29:48
SLE in CEE setting( Hungary, Poland, Romania) an insight on medical, economic and social burdenSESAME
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: SLE in CEE setting( Hungary, Poland, Romania) an insight on medical, economic and social burden
Trial description: Systemic Lupus Erythematosus (SLE), is a chronic, multisystem, autoimmune disease that can be life threatening when major organs have been affected. The high variability and its unpredictable course (flaring/remission), combined with a lack of indicated and integrated treatments, induce a high unmet need within the patients population. Recording and monitoring patients with SLE would help to create a global but - at the same time - detailed image about patients and their disease and could be useful for all the stakeholders. The collected information may be used for clinical research, for health planners, clinical management and education/ information for patients/ HCPs/ payers, etc.The expected key outcomes of the , containing socio - demographic, clinical and pharmacoeconomic information, would cover the following issues: 1. Unmet-needs identification for SLE patients in Romanian, Polish and Hungarian settings; 2. Have a real life picture of the medical, economic and social burden of SLE; 3. Piloting the Patient Registry e- tool, as a potential base for National Patients Registry for SLE.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
• proportion of severe and non-severe forms of
Timeframe: one year
• proportion of patients with anti ds-DNA antibodies positive and low complement ;
Timeframe: one year
•SELENA-SLEDAI scores distribution;
Timeframe: one year
• patients distribution according to SLICC / ACR
Timeframe: one year
Secondary outcomes:
• patients distribution upon baseline characteristics (age, gender, ethnicity, social and educational status, SLE duration);
Timeframe: one year
• average number of medical services per patient and per year (per type of service, overall and by disease severity);
Timeframe: one year
• average yearly cost for health services per patient – overall, per severity of disease and per flare/non-flare patients;
Timeframe: one year
Interventions:
Not applicable
Enrollment:
960
Primary completion date:
Not applicable
Observational study model:
Case-Only
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
May 2011 to March 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 80 Year
Accepts healthy volunteers
none
- Inclusion Criteria:
- male or female ≥ 18 years;
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- with previous diagnosis or newly diagnosed with SLE
- has given written informed consent. Exclusion criteria
- Patients who are included into other clinical trials at the moment of the enrolment, will not be considered for this study .
male or female ≥ 18 years;
meeting at least 4 ACR criteria ;
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
2015-11-03
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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