Trial record 10 of 24 for:    Progressive Multifocal Leukoencephalopathy

Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01211665
First received: July 29, 2010
Last updated: September 12, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Immune Reconstitution Inflammatory Syndrome
Leukoencephalopathy, Progressive Multifocal
Drug: corticosteroids
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Time course change in functional status based on Karnofsky Performance Status Scale through 6 months following the completion of PLEX or Equivalent [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Survival at 6 months following the completion of PLEX or equivalent [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Measure of symptom severity, treatment response and the efficacy of treatments using the Global Clinical Impression of Improvement (GCI-I) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Measure cerebral dysfunction using Symbol Digit Modalities Test (SDMT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Measure Gadolinium enhancing lesions using Brain Magnetic Resonance Imaging (MRI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mapping of brain activity using Magnetoencephalography (MEG) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Laboratories (Chemokines, Cytokines, C-reactive protein, JCV load and cell count in cerebral fluid (CSF)) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pulsed IVMP
4 weekly cycles (1g/day for 3 days)
Drug: corticosteroids
IVMP
Active Comparator: IVMP with oral prednisolone taper
IVMP 1g/day for 6 days followed by an oral taper of over 2 months
Drug: corticosteroids
IVMP

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug including hypersensitivity to corticosteroids.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211665

Locations
United States, Massachusetts
Research Site
Cambridge, Massachusetts, United States, 01720
Germany
research Site
Bochum, Germany, 44791
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01211665     History of Changes
Other Study ID Numbers: 101JC404
Study First Received: July 29, 2010
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by Biogen Idec:
IVMP
corticosteroids
IRIS
Progressive Multifocal Leukoencephalopathy
Immune resconstitution inflammatory syndrome
PML

Additional relevant MeSH terms:
Leukoencephalopathy, Progressive Multifocal
Leukoencephalopathies
Immune Reconstitution Inflammatory Syndrome
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Polyomavirus Infections
DNA Virus Infections
Slow Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Demyelinating Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014