Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS) (IRIS)
Immune Reconstitution Inflammatory Syndrome, Leukoencephalopathy, Progressive Multifocal
About this trial
This is an interventional treatment trial for Immune Reconstitution Inflammatory Syndrome focused on measuring IVMP, corticosteroids, IRIS, Progressive Multifocal Leukoencephalopathy, Immune reconstitution inflammatory syndrome, PML
Eligibility Criteria
Key Inclusion Criteria:
- Must have been receiving natalizumab for multiple sclerosis (MS) prior to the diagnosis or suspicion of Progressive multifocal leukoencephalopathy (PML).
- Subject must be willing to undergo or have completed plasma exchange (PLEX) prior to initiating study treatment.
Key Exclusion Criteria:
- History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug including hypersensitivity to corticosteroids.
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Pulsed IVMP
IVMP with oral prednisolone taper
Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper of prednisolone over 2 months (suggested dosages starting at 80 mg and tapering to 5 mg). If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.