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.
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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