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Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Immune Reconstitution Inflammatory Syndrome; Leukoencephalopathy, Progressive Multifocal

Intervention: Methylprednisolone (Drug); Prednisolone (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

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.

Clinical Details

Official title: High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Time Course Change in Functional Status Based on Karnofsky Performance Status Index Through 6 Months Following Completion of Plasma Exchange (PLEX)

Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Severity of AEs and SAEs

Time Course Change in the Global Clinical Impression of Improvement (GCI-I) Scale

Time Course Change in Cerebral Dysfunction Using the Symbol Digit Modalities Test (SDMT)

Time Course Changes in Brain Magnetic Resonance Imaging (MRI)

Time Course Change in Magnetoencephalography (MEG) Results

Time Course Change in Clinical Laboratory Values

Time Course Elimination of Serum Natalizumab Concentration Following Plasma Exchange (PLEX) or Equivalent

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Research Site, Bochum, Germany

Research Site, Wurzburg, Germany

Research Site, Hastings, Nebraska, United States

Additional Information

Starting date: September 2010
Last updated: August 26, 2014

Page last updated: August 23, 2015

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