Clinical Trial

Establishing the Salience of Type 1 Interferon Pathway Blockade in the Central Mechanisms of SLE Related Fatigue

Study acronym: EPIC
Not Yet Recruiting
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Record status
This record was last updated January 29, 2025 (before its estimated March 17, 2025 completion). Its status may not reflect the trial's current state.
Summary
Systemic Lupus Erythematosus (SLE) is a multi-system autoimmune disorder, characterised by activation of the interferon system. Of the multiple domains of this disease, patients identify fatigue as the most pervasive and disabling aspect. As many as 90% report significant levels of fatigue, a prevalence far in excess of that observed in the general population and most other chronic disorders. Moreover, its impact permeates all aspects of living as reflected by fatigue's strong relationship with impaired quality of life3 and work disability. Despite these substantial consequences, relatively little is known about this symptom and so the current dearth of accepted therapies is unsurprising. A better understanding of the underlying mechanisms of fatigue will be vital if efficacious interventions are to be developed in the future. The investigators will recruit 25 SLE patients to achieve 20 full data sets. They will attend for a baseline 7T brain scan to primarily measure basal ganglia glutamate and then receive 5 months of a pharmacological blocker that antagonises type 1 interferon receptors before completing the study with a final 7T brain scan to undertake repeat measure of basal ganglia glutamate.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-17.
Trial Details
NCT Number NCT06784076
Lead Sponsor NHS Greater Glasgow and Clyde
Conditions Systemic Lupus Erythematosus
Enrollment 20 participants
Start Date 2025-03-17
Primary Completion 2025-03-17 (estimated)
Study Completion 2027-03-15 (estimated)
Updated on ClinicalTrials.gov 2025-01-29