Improving the Assessment of SLE Disease Activity

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · May 3, 2017

Keywords

ClinConnect Summary

Objectives:

1. To describe the development and initial validation of the SLEDAI-2KG using the Toronto Lupus Cohort (TLC) database.
2. To conduct further validation of SLEDAI-2KG using BLISS trial data.
3. To assess concurrent construct validity of SLEDAI-2KG prospectively in the University of Toronto Lupus Clinic.

Study design:

1. Objective one is a single center study aiming to derive a new index, SLEDAI-2KG, based on SLEDAI-2K. Scoring of SLEDAI-2KG will be determined in this study.
2. Objective two is a retrospective analysis conducted on prospectively collected data from two clinical...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Objective I:
• • ≥4 American College of Rheumatology (ACR) criteria or 3 ACR criteria plus a typical histological lesion of SLE on renal or skin biopsy
• • Clinician's diagnosis based on his/her assessment
• • Patients from the Toronto Lupus Clinic with regular follow-up, defined as having follow up visits at 3 and 6 months from the baseline visit (1st study visit).
• Objective II:
• • • Participant in the BLISS-52 and BLISS-76 trials
• Objective III:
• • ≥4 American College of Rheumatology (ACR) criteria or 3 ACR criteria plus a typical histological lesion of SLE on renal or skin biopsy
• • Increase in SLEDAI-2K ≥4
• • Clinician's diagnosis based on his/her assessment
• Exclusion Criteria:
• Objective I and III:
• • Patients with missing follow up visits at 3 and 6 months from the baseline visit (1st study visit).
• • Patients with missing data in the charts for all visits.
• Objective II:
• • • Participants who did not complete the trial and therefore have missing data points for primary endpoint measures