Clinical Trials Directory

Trials / Terminated

TerminatedNCT01211665

Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)

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

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Biogen · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGMethylprednisoloneIn intravenous form (for a daily dose of 1 g/day on treatment days).
DRUGPrednisoloneOral prednisolone used as a taper, with suggested dosages starting at 80 mg and tapering to 5 mg.

Timeline

Start date
2010-09-01
Primary completion
2012-02-01
Completion
2012-02-01
First posted
2010-09-29
Last updated
2014-09-05
Results posted
2014-08-13

Locations

3 sites across 2 countries: United States, Germany

Source: ClinicalTrials.gov record NCT01211665. Inclusion in this directory is not an endorsement.