multiple sclerosis patients with neutralizing antibodies against interferon-beta
Conditions
Interventions
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
Concentrat
Sponsors
Medical University Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: < 18 years old neutralizing antibodies < 500 NU pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. The last follow up after 6 months. | — |
Countries
Austria
Outcome results
None listed