A Randomized Controlled, Open-Label, Rater-Blinded Pragmatic Trial, Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
The purpose of this research is to evaluate if early vs rescue Therapeutic Plasma Exchange (PLEX) treatment algorithm leads to better visual outcomes in severe Optic Neuritis and leads to better neurological disability outcomes in severe Transverse Myelitis.
• ≥18 years of age
• MRI orbits demonstrating evidence of new T2 hyperintensity and/or post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis
• Visual acuity 20/200 or worse
• Within 8 days of onset of visual symptoms
• Able to initiate PLEX within 72h of the first dose of HDCS (if randomized to the Early PLEX treatment arm)
• Able to sign and date informed consent form
• Willingness to comply with all study procedures and availability for the duration of the study
• ≥18 years of age
• Diagnosis of Transverse Myelitis (defined based on modified criteria adapted from the 2002 Transverse Myelitis Consortium Working Group; ALL are required)
‣ Development of sensory, motor and/or autonomic symptomatology attributable to spinal cord dysfunction
⁃ Onset of symptoms to nadir \>12 hours
⁃ Exclusion of extra-axial compressive etiology by neuroimaging
⁃ Demonstration of inflammation within the spinal cord by presence of intramedullary T2 lesion (post-gadolinium enhancing OR non-enhancing) on MRI
• Expanded Disability Status Scale \[EDSS\] ≥3.0 (excluding visual and cerebral functional systems)
• EDSS Pyramidal Functional System Score ≥ 2
• Within 8 days of onset of motor symptoms
• Able to initiate PLEX within 48h of the first dose of HDCS (if randomized to the Early PLEX treatment arm)
• Able to sign and date informed consent form
• Willingness to comply with all study procedures and availability for the duration of the study