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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2016 |
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Main ID: |
NCT01616472 |
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Date of registration:
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07/06/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins)
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Scientific title:
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WEUKBRE5716: Quantifying the Burden of Steroid-related Damage in Systemic Lupus Erythematosus in the Hopkins Lupus Cohort |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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1 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01616472 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Retrospective
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Phase:
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N/A
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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:
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Cumulative corticosteroid exposure
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Primary Outcome(s)
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New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis
[Time Frame: Over a period of 25 years from 1987-2011]
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Secondary ID(s)
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116015
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WEUKBRE5716
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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