Stopped: This study was stopped prematurely due to lack of enrollment within a 1-5-year period.
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.
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Time Course Change in Functional Status Based on Karnofsky Performance Status Index Through 6 Months Following Completion of Plasma Exchange (PLEX)
Timeframe: Baseline up to 6 months
Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)
Timeframe: 6 months
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period
Severity of AEs and SAEs
Timeframe: from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period
Time Course Change in the Global Clinical Impression of Improvement (GCI-I) Scale
Timeframe: Screening to 6 months following completion of PLEX (participants began treatment with intravenous methylprednisolone (IVMP) within 2 weeks after PLEX [or equivalent]).
Time Course Change in Cerebral Dysfunction Using the Symbol Digit Modalities Test (SDMT)
Timeframe: Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).
Time Course Changes in Brain Magnetic Resonance Imaging (MRI)
Timeframe: Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).
Time Course Change in Magnetoencephalography (MEG) Results
Timeframe: Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).
Time Course Change in Clinical Laboratory Values
Timeframe: Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).
Time Course Elimination of Serum Natalizumab Concentration Following Plasma Exchange (PLEX) or Equivalent
Timeframe: Baseline up to 6 months