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

Conditions: MedDRA version: 12.1Level: PTClassification code 10054014Term: Immune reconstitution syndrome
Immune Reconstitution Inflammatory Syndrome

Registration Number: EUCTR2010-020369-26-DE

Lead Sponsor: Biogen Idec

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

1. The subject or his/her legally authorized representative must understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
2. Age 18 years or older at the time of informed consent.
3. Subjects of childbearing potential must practice effective contraception during the study.
4. Must have been receiving natalizumab for multiple sclerosis prior to the diagnosis or suspicion of PML.
5. Subject must be willing to undergo or have completed PLEX (or equivalent) prior to initiating study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug including hypersensitivity to corticosteroids.
2. Female subjects who are pregnant or currently breastfeeding or are considering becoming pregnant while in the study.
3. Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
4. Any other condition, clinical finding, or reason that, in the opinion of the Investigator and/or the Sponsor, is determined to be unsuitable for enrollment into this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ;Main Objective: • To explore the effects of administering high-dose corticosteroids to subjects who develop Progressive Multifocal Leukoencephalopathywhile on natalizumab<br>• To characterize the evolution of Immune Reconstitution Inflammatory Syndrome<br>• To characterize the time course elimination of serum natalizumab concentrations in the study population following the last plasma exchange procedure<br>;Primary end point(s): • Karnofsky Performance Status Scale<br>• Survival<br>• Adverse events and serious adverse events<br>• Global Clinical Impression of Improvement<br>• Symbol Digit Modalities Test<br>• Brain magnetic resonance imaging<br>• Magnetoencephalography<br>• Chemokines, cytokines, C-reactive protein<br>• JCV load and cell count in cerebrospinal fluid<br>• Serum natalizumab concentrations<br>

Secondary Outcome Measures