WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins)

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Cumulative corticosteroid exposure

• Registration Number: NCT01616472
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Incident hypertension cases	Cumulative corticosteroid exposure	Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with hypertension during follow-up, subsequent to SLE diagnosis.
Incident diabetes cases	Cumulative corticosteroid exposure	Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with diabetes during follow-up, subsequent to SLE diagnosis.
Incident hypertension controls	Cumulative corticosteroid exposure	Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of hypertension during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+
Incident cataract cases	Cumulative corticosteroid exposure	Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with cataract during follow-up, subsequent to SLE diagnosis.
Incident cataract controls	Cumulative corticosteroid exposure	Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of cataract during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+
Incident osteoporosis cases	Cumulative corticosteroid exposure	Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with osteoporosis during follow-up, subsequent to SLE diagnosis.
Incident osteoporosis controls	Cumulative corticosteroid exposure	Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of osteoporosis during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+
Incident diabetes controls	Cumulative corticosteroid exposure	Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of diabetes during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+
Incident avascular necrosis cases	Cumulative corticosteroid exposure	Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who are newly diagnosed with avascular necrosis during follow-up, subsequent to SLE diagnosis
Incident avascular necrosis controls	Cumulative corticosteroid exposure	Individuals with newly diagnosed SLE selected from the Hopkins Lupus Cohort (1987-2011) who have no record of avascular necrosis during follow-up time (years) since SLE diagnosis that is equivalent to length of case at-risk time. Controls are matched to cases on decade of SLE diagnosis: 1987-1989, 1990-1999, 2000-2009, 2010+

Primary Outcome Measures

Name	Time	Method
New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis	Over a period of 25 years from 1987-2011	New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis recorded after SLE diagnosis in the Hopkins Lupus cohort