Last updated:  07/21/2020 17:00:12
WEUKBRE5716: Steroid-related damage in systemic lupus erythematosus (Hopkins)
Clinicaltrials.gov ID 
EudraCT ID 
Not applicable
EU CT Number 
Not applicable
Trial status 
                  Study complete
                
Study complete
Trial overview
Official title: WEUKBRE5716: Quantifying the burden of steroid-related damage in systemic lupus erythematosus in the Hopkins Lupus Cohort
Trial description: The study is designed to assess the association between steroid exposure and five potentially steroid-related adverse events within a cohort of individuals with systemic lupus erythematosus (SLE).  Study objectives are to quantify the fraction of the risk of new (i) diabetes, (ii) hypertension, (iii) cataracts, (iv) osteoporosis and (v) avascular necrosis that is attributable to cumulative corticosteroid exposure in SLE patients.  The study will consist of five matched case-control analyses nested within the Hopkins Lupus Cohort.  Cases will be incident SLE cases who have developed one of the case outcomes (diabetes, hypertension, cataracts, osteoporosis with fracture or vertebral collapse or avascular necrosis).  Controls will be matched to cases on time since SLE diagnosis.  The primary exposures to be assessed are cumulative dose of steroid (g) and cumulative duration of exposure to steroids.  The extent of the risk associated with steroids will be explored through modeling of the relationship and through calculation of attributable risks of exposure (number of cases associated with the highest exposure quartile of each primary exposure).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis
Timeframe: Over a period of 25 years from 1987-2011
Secondary outcomes: 
Not applicable
Interventions:
Enrollment:
1
Primary completion date:
2016-22-01
Observational study model:
Case-Control
Time perspective:
Retrospective
Clinical publications:
Julie E Davidson, Qinggong Fu, Sapna Rao, Laurence S Magder, Michelle Petri. Quantifying the burden of steroid-related damage in systemic lupus erythematosus in the Hopkins Lupus Cohort.. Lupus Sci Med. 2018;5:e000237.
DOI: 10.1136/lupus-2017-000237 
PMID: 29765616
- Newly diagnosed SLE as per ACR criteria
 - No history of “case” event of interest in follow-up time prior to SLE diagnosis (case) or during follow-up time since SLE diagnosis that is equivalent to length of case at-risk time period (controls)
 
- None
 
Inclusion and exclusion criteria
Inclusion criteria:
- Newly diagnosed SLE as per ACR criteria
 - No history of “case” event of interest in follow-up time prior to SLE diagnosis (case) or during follow-up time since SLE diagnosis that is equivalent to length of case at-risk time period (controls)
 
Exclusion criteria:
- None
 
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Clinical study report
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
2016-22-01
Actual study completion date
2016-22-01
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