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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2010-020369-26-DE
Date of registration: 18/08/2010
Prospective Registration: Yes
Primary sponsor: Biogen Idec
Public title: High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab
Scientific title: High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab
Date of first enrolment: 29/11/2010
Target sample size: 20
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020369-26
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Germany
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
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Key inclusion & exclusion criteria
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Immune Reconstitution Inflammatory Syndrome
MedDRA version: 12.1 Level: PT Classification code 10054014 Term: Immune reconstitution syndrome
Intervention(s)

Product Name: methylprednisolone
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: METHYLPREDNISOLONE
CAS Number: 83-43-2
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-

Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-

Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 1-

Product Name: prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 2-

Primary Outcome(s)
Main Objective: • To explore the effects of administering high-dose corticosteroids to subjects who develop Progressive Multifocal Leukoencephalopathywhile on natalizumab
• To characterize the evolution of Immune Reconstitution Inflammatory Syndrome
• To characterize the time course elimination of serum natalizumab concentrations in the study population following the last plasma exchange procedure
Secondary Objective:
Primary end point(s): • Karnofsky Performance Status Scale
• Survival
• Adverse events and serious adverse events
• Global Clinical Impression of Improvement
• Symbol Digit Modalities Test
• Brain magnetic resonance imaging
• Magnetoencephalography
• Chemokines, cytokines, C-reactive protein
• JCV load and cell count in cerebrospinal fluid
• Serum natalizumab concentrations
Secondary Outcome(s)
Secondary ID(s)
101JC404
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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