Last updated: 07/21/2020 17:00:12

WEUKBRE5716: Steroid-related damage in systemic lupus erythematosus (Hopkins)

GSK study ID
116015
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
Drug: Cumulative corticosteroid exposure
Enrollment:
1
Observational study model:
Case-Control
Primary completion date:
2016-22-01
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
Medical condition
Systemic Lupus Erythematosus
Product
prednisone
Collaborators
Not applicable
Study date(s)
April 2012 to January 2016
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
  • 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

Trial location(s)

No location data available.

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
Finalized
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
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