Last updated: 01/29/2025 06:40:07
Long Term Organ Damage in SLE
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Organ Damage Associated With Systemic Lupus Erythematosus: An Analysis of Commercial Health Insurance Claims Data to Evaluate Burden of Illness
Trial description: Systemic lupus erythematosus (SLE) is a chronic, multisystem, inflammatory, autoimmune disease that affects multiple organ systems and is characterized by unpredictable exacerbations, commonly referred to as flares, followed by remission. Although, organ damage (OD) highly co-occurs with SLE and is associated with poor disease prognosis, real-world studies assessing the economic implications of OD in SLE are limited. In this regard, the purpose of this study is to examine the burden, in terms of health care resource use (HCRU) and costs, of OD in adults with SLE from the perspective of the third-party payer in the United States (US).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Costs: comparison of costs before and after diagnosis of OD among adult participants with SLE
Timeframe: 12 months
Secondary outcomes:
Costs: comparison of costs between adult participants with SLE with and without OD
Timeframe: 12 months
Frequency of OD
Timeframe: 12 months
Demographic, clinical and economic characteristics: comparison of demographic, clinical, and economic characteristics between adult patients with SLE with and without OD (overall and by organ system)
Timeframe: 12 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-15-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Christopher F Bell, Mayank R Ajmera, Juliana Meyers. An evaluation of costs associated with overall organ damage in patients with systemic lupus erythematosus in the USA. Lupus. 2022;31(2):202-211
DOI:10.1177/09612033211073670
PMID:35060407
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
December 2019 to November 2020
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- For the OD Cohort
- Participants had OD, defined as: At least one diagnosis on an inpatient claim during the identification period with an International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) or ICD-10-CM code of a medical condition listed in the SDI or at least three outpatient claims during the identification period with an ICD-9-CM or ICD-10-CM code of a medical condition listed in the SDI within the same organ system within a 6-month period (e.g., 3 claims within 6 months with a diagnosis indicating OD to the cardiovascular system) to establish permanent OD.
- Participants diagnosed with drug-induced SLE.
- Participants not satisfying the above mentioned inclusion criteria will be excluded.
Inclusion and exclusion criteria
Inclusion criteria:
- For the OD Cohort
- Participants had OD, defined as: At least one diagnosis on an inpatient claim during the identification period with an International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) or ICD-10-CM code of a medical condition listed in the SDI or at least three outpatient claims during the identification period with an ICD-9-CM or ICD-10-CM code of a medical condition listed in the SDI within the same organ system within a 6-month period (e.g., 3 claims within 6 months with a diagnosis indicating OD to the cardiovascular system) to establish permanent OD.
- Participants with at least one inpatient visit with diagnosis codes for SLE or two outpatient visits (at least 30 days apart) with diagnosis codes for SLE prior to OD index date. The date of the first encounter with a diagnosis of SLE will be termed the SLE index date.
- Participants aged 18 years or older as of the SLE index date.
- Participants with greater than or equal to 12 months continuous health plan enrollment with both medical and pharmacy coverage pre–OD index date.
- Participants with greater than or equal to 12 months continuous health plan enrollment with both medical and pharmacy coverage post–OD index date. For No OD Cohort:
- Participants with at least one inpatient visit with diagnosis codes for SLE or two outpatient visits (at least 30 days apart) with diagnosis codes for SLE between 01-April-2009 to 31-March-2017. The date of the first encounter during the identification period with a diagnosis of SLE will be termed the SLE index date.
- Participants aged 18 years or older as of the SLE index date.
- Participants with greater than or equal to 12 months continuous enrollment with both medical and pharmacy coverage pre–SLE index date.
- Participants with greater than or equal to 12 months continuous enrollment with both medical and pharmacy coverage post–SLE index date.
Exclusion criteria:
- Participants diagnosed with drug-induced SLE.
- Participants not satisfying the above mentioned inclusion criteria will be excluded.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
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
2020-15-11
Actual study completion date
2020-15-11
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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