Scrutinizing the Heterogeneity of SLE: Defining Phenotypes

NCT03348774 | Unknown

• 1 other identifier: 17-5083
• Study Type: observational
• Target: 950
• Locations: 1 country
• Sites: 1

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, meaning that these patients have active disease before and immediately after diagnosis and after some time they achieve prolonged remission (for 12 years on average). Interestingly, about half of these patients do so and require no medications. On the other end of the clinical spectrum, approximately 50% of the patients demonstrate persistent disease activity and usually have the highest risk for developing co-morbidities and irreversible damage. A major goal of clinical research in SLE is to improve disease management based on disease course. By better characterizing SLE disease course we hope to better identify patients early in the disease course for targeted therapies to prevent and or reduce future SLE complications. The overall objective of our project is to define distinct phenotypes of SLE based on disease course, clinical features, pathogenic mechanisms, genetic factors and relevant biomarkers.

Conditions

Systemic Lupus Erythematosus

Keywords

Disease Course

Outcome Measures

Primary Outcomes (1)

• Disease Course Patterns

  All 49,000 visits within the Toronto Lupus Cohort will be probed for patterns of disease activity using SLEDAI-2K measurements on each assessment. A finite mixture model will be fitted to the data to accommodate for three sub-populations of patients. Disease course for each sub-populations will be defined in terms of multistate model where the states reflected meaningfully different degrees of disease activity as measured by the SLEDAI-2K scores.

  6 months

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with SLE have been followed prospectively at the University of Toronto Lupus Clinic since 1970. All patients ≥4 or more of the 1997 ACR criteria for SLE, or have 3 criteria and a typical lesion of SLE on renal or skin biopsy. Patients are evaluated at 2-6 month intervals according to a standard protocol which includes a detailed clinical history, physical examination, and laboratory evaluation . It includes all information necessary to calculate disease activity and damage indices, as well as comorbidities. Disease activity is assessed by the SLE Disease Activity Index 2000 (SLEDAI-2K) , and accumulated damage by the SLICC/ACR damage index (SDI) . To date there are 1767 patients with 2 or more visits registered in the Lupus Clinic Database, with 43079 assessments recorded. Their characteristics are shown in Table 1.

You may qualify if:

• ≥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

You may not qualify if:

• Patients who have not had 2 assessment visits for aims 1 and 2
• Patients who have not had 6 assessments for aim 3.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Disease Progression

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Murray Urowitz

  University Health Network and University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priniple Investigator

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: November 21, 2017
• Study Start: February 9, 2017
• Primary Completion: June 30, 2018
• Study Completion: July 30, 2018
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)