382
Participants
Start Date
July 11, 2025
Primary Completion Date
April 1, 2029
Study Completion Date
April 30, 2031
High-dose corticosteroids (HDCS)
"Subjects will receive initial treatment with high-dose corticosteroids (HDCS) in the form of methylprednisolone (1,000mg daily) administered intravenously for 5 days or a bioequivalent dose of oral corticosteroids (e.g., 1,250mg prednisone daily or 176mg dexamethasone daily).~Subjects will be escalated to PLEX if there is an insufficient response to HDCS (decision point at 14±2 days for the ON sub-trial and 7±2 days for the TM sub-trial) PLEX will be performed as 5 sessions over 5-10 days, with 1-1.5 plasma volumes exchanged per session."
High-dose corticosteroids (HDCS) and PLEX
"Subjects will receive treatment with high-dose corticosteroids (HDCS) and PLEX initiated concurrently.~HDCS will be administered in the form of methylprednisolone (1,000mg daily) administered intravenously for 5 days or a bioequivalent dose of oral corticosteroids (e.g., 1,250mg prednisone daily or 176mg dexamethasone daily).~PLEX will be performed as 5 sessions over 5-10 days, with 1-1.5 plasma volumes exchanged per session."
RECRUITING
Johns Hopkins University, Baltimore
RECRUITING
Mayo Clinic in Rochester, Rochester
Lead Sponsor
Patient-Centered Outcomes Research Institute
OTHER
Mayo Clinic
OTHER