Status:
TERMINATED
Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)
Lead Sponsor:
Biogen
Collaborating Sponsors:
Elan Pharmaceuticals
Conditions:
Immune Reconstitution Inflammatory Syndrome
Leukoencephalopathy, Progressive Multifocal
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 a...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01211665
Start Date
September 1 2010
End Date
February 1 2012
Last Update
September 5 2014
Active Locations (3)
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1
Research Site
Hastings, Nebraska, United States
2
Research Site
Bochum, Germany
3
Research Site
Würzburg, Germany