Status:
UNKNOWN
Scrutinizing the Heterogeneity of SLE: Defining Phenotypes
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Systemic Lupus Erythematosus
Eligibility:
FEMALE
Brief Summary
SLE disease course is characterized by unpredictable relapses and remissions in the majority of patients. However, in a small proportion (approximately 5%), SLE presents with a monophasic pattern, mea...
Detailed Description
Specific aims of this study are: 1. To test the clinical impression of the disease courses by modeling the course of the disease in each of three sub-populations of patients where it is anticipated t...
Eligibility Criteria
Inclusion
- Patients enrolled in the study for aims 1 and 2 must meet the following inclusion criteria:
- ≥4 American College of Rheumatology (ACR) criteria or 3 ACR criteria plus a typical histological lesion of SLE on renal or skin biopsy.
- Patients must have a minimum of 2 assessment visits.
- Patients enrolled in the study for aim 3 must meet the following criteria:
- Must be inception patients seen within one year of diagnosis of SLE
- ≥4 American College of Rheumatology (ACR) criteria or 3 ACR criteria plus a typical histological lesion of SLE on renal or skin biopsy.
- Patients must have a minimum of 6 assessment visits to ensure categorization into one of the disease courses derived in aims 1 and 2
Exclusion
- Patients who have not had 2 assessment visits for aims 1 and 2
- Patients who have not had 6 assessments for aim 3.
Key Trial Info
Start Date :
February 9 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 30 2018
Estimated Enrollment :
950 Patients enrolled
Trial Details
Trial ID
NCT03348774
Start Date
February 9 2017
End Date
July 30 2018
Last Update
November 21 2017
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5T2S8