Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)
Status:
Terminated
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
The objectives of this study are to explore the effects of administering high-dose
corticosteroids to participants who developed progressive multifocal leukoencephalopathy
(PML) while on natalizumab as measured by time-course change in functional status based on
Karnofsky Performance Status Index through 6 months following the completion of plasma
exchange (PLEX; or equivalent), survival at 6 months following the completion of PLEX (or
equivalent), and incidence and severity of adverse events (AEs) and serious adverse events
(SAEs); to characterize the evolution of immune reconstitution inflammatory syndrome (IRIS)
as measured by time course changes in Global Clinical Impression of Improvement (GCI-I),
Symbol Digit Modalities Test (SDMT), brain magnetic resonance imaging (MRI),
magnetoencephalography (MEG), chemokines, cytokines, C-reactive protein (CRP), John
Cunningham virus (JCV) load and cell count in cerebrospinal fluid (CSF); and to characterize
the time course elimination of serum natalizumab concentrations in the study population
following the last PLEX (or equivalent) procedure.