Immune tolerance induction in MS patients with neutralizing antibodies against interferon-beta - HINABS
- Conditions
- multiple sclerosis patients with neutralizing antibodies against interferon-beta
- Registration Number
- EUCTR2009-013284-19-AT
- Lead Sponsor
- Medical University Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. ;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.;Primary end point(s): Non-respond of MxA RNA, a biomarker for interferon-beta bioavailability, after 2 infusions of 48 MIU interferon-beta. <br>The last follow up after 6 months.
- Secondary Outcome Measures
Name Time Method