Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)



Status:Archived
Conditions:Infectious Disease, Neurology
Therapuetic Areas:Immunology / Infectious Diseases, Neurology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2010
End Date:February 2013

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


The purpose of this study is to look at the effect of 2 different corticosteroid treatment
schedules in the setting of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients
who have developed Progressive Multifocal Leukoencephalpathy (PML) while on treatment with
natalizumab.


The purpose of this study is to evaluate the effect of 2 treatment regimens, in patients who
have developed Progressive Multifocal Leukoencephalpathy (PML) while on natalizumab
treatment. These regimens are consistent with the current use and dosage of corticosteroids
in the setting of Immune Reconstitution Inflammatory Syndrome (IRIS). The main assessment
criteria is change in clinical status (as measured by Karnofsky Performance Status Scale)
over approximately 6 months. Both treatment assume that natalizumab has been removed to the
extent possible by plasma exchange and therefore, the trafficking of immune cells to the CNS
has been restored.


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