TIMELY-PLEX Study: Treatment of Inflammatory Myelitis and Optic Neuritis with Early vs Rescue Plasma Exchange

TIMELY-PLEX is a randomized, controlled, open-label, rater-blinded pragmatic trial, including two sub-trials: optic neuritis and transverse myelitis. This PCORI-funded study is being led by Mayo Clinic and Johns Hopkins and includes 31 participating sites across the U.S. Eligible participants are adults (≥18 years) with severe acute optic neuritis (20/200 or worse) or transverse myelitis (Expanded Disability Status Scale of 3.0 or worse) within 8 days of symptom onset. Patients are randomized to receive either early plasma exchange (PLEX) concurrently with high-dose corticosteroids or corticosteroids alone followed by rescue PLEX if there is not significant recovery at day 14+/-2 for optic neuritis and day 7+/-1 for transverse myelitis.

This study’s findings will be pivotal in establishing the effectiveness and optimal timing of PLEX for severe optic neuritis and transverse myelitis.

ClinicalTrials.gov Identifier: NCT07100990

See the participating clinical sites on the map below. For site details, visit ClinicalTrials.gov