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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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10 July 2015 |
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Main ID: |
EUCTR2009-013284-19-AT |
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Date of registration:
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23/11/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Immune tolerance induction in MS patients with neutralizing antibodies against interferon-beta - HINABS
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Scientific title:
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Immune tolerance induction in MS patients with neutralizing antibodies against interferon-beta - HINABS |
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Date of first enrolment:
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10/12/2009 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013284-19 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Austria
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
diagnosed multiple sclerosis
> 18 years old
prior or current therapy with interferon-beta
neutralizing antibodies > 500 NU
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:
< 18 years old
neutralizing antibodies < 500 NU
pregnancy
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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multiple sclerosis patients with neutralizing antibodies against interferon-beta
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Intervention(s)
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Trade Name: Betaferon
Pharmaceutical Form: Intravenous infusion
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: million IU million international units
Concentration type: equal
Concentration number: 48-
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Primary Outcome(s)
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Primary end point(s): Non-respond of MxA RNA, a biomarker for interferon-beta bioavailability, after 2 infusions of 48 MIU interferon-beta.
The last follow up after 6 months.
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Main Objective: How many multiple slerosis patients show a reduction of the neutralizing antibodies < 100 neutralizing units after 3 months of weekly intravenous interferon-beta infusion.
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Secondary Objective: What is the absolute reduction of the neutralizing antibody titre after 3 months of weekly intravenous interferon-beta infusion and after 3 further months. Do lesions show a reduced MR-activity after the end of the interferon-beta infusions. Does activity of peripheral blood mononuclear cells change over the study period.
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Secondary ID(s)
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HINABS-ITI
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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