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

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).

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Bone Diseases Bone Diseases, Metabolic Cardiovascular Diseases Cataract Connective Tissue Diseases Diabetes Mellitus Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Hypertension Immune System Diseases Lens Diseases Lupus Erythematosus, Systemic Metabolic Diseases Musculoskeletal Diseases Necrosis Nutritional and Metabolic Diseases Osteonecrosis Osteoporosis Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cumulative corticosteroid exposure

Drug

Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.

Primary outcomes

New diagnoses of diabetes, hypertension, cataracts, osteoporosis, or avascular necrosis

Time frame: 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

WEUKBRE5716: Quantifying the Burden of Steroid-related Damage in Systemic Lupus Erythematosus in the Hopkins Lupus Cohort

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Jun 11, 2012
Registry last updated: Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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