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
Study complete
Study complete
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
    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
    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)

    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
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