Development of neutralising antibodies against Interferon-beta in the treatment of multiple sclerosis
Conditions
Interventions
Trade Name: Avonex
Pharmaceutical Form: Injection
INN or Proposed INN: Interferon-beta 1a
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: µg/ml microgram(s)/mill
Sponsors
Medizinische Universität Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients of more than 18 years old diagnosed with MS according to the valid McDonald criteria at the time of diagnosis - Patient for whom the investigator decided to prescribe IFNbeta (Avonex, Betaferon, Rebif, and Extavia) in first line in the usual manner in accordance with the terms of the marketing authorization, independent from entry in study. 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients who had previous treatment with any IFNbeta preparation or neutralizing antibodies against IFNbeta at baseline visit - Pregnant or breast-feeding women - Patients with any concomitant disease or treatment that could bias primary evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify early biomarkers within 3 months of IFN-beta treatment able to predict immunization against IFN-beta within the 18 months of treatment in MS patients ;Secondary Objective: • To characterize kinetic development of binding antibodies against IFNbeta for the prediction of neutralizing antibodies • To establish a biological relevant level of neutralizing ADA by PK/PD markers • To identify molecular and cellular biomarkers associated with the development of ADA • To be able to associate an immunological signature to patients with ADA • Ex-vivo evaluation of early activation biomarkers as potential predictors of immunogenicity • T- and B-cell AD responses: Clonality analysis and epitope mapping • Evaluation of B cell AD cellular response • Analyze the difference between ADA+/ADA- patients regarding skin immunology at the injection site (some participating sites only) • Differences in biomarkers for neurodegeneration between ADA+/ADA- patients (Karolinska Institutet only) ;Primary end point(s): To identify early biomarkers within 3 months of IFN-beta treatment able to predict immunization against IFN-beta within the 18 months of treatment in MS patients ;Timepoint(s) of evaluation of this end point: At end of study (2016-2017) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To characterize kinetic development of binding antibodies against IFNbeta for the prediction of neutralizing antibodies • To establish a biological relevant level of neutralizing ADA by PK/PD markers • To identify molecular and cellular biomarkers associated with the development of ADA • To be able to associate an immunological signature to patients with ADA • Ex-vivo evaluation of early activation biomarkers as potential predictors of immunogenicity • T- and B-cell AD responses: Clonality analysis and epitope mapping • Evaluation of B cell AD cellular response • Analyze the difference between ADA+/ADA- patients regarding skin immunology at the injection site (some participating sites only) • Differences in biomarkers for neurodegeneration between ADA+/ADA- patients (Karolinska Institutet only) ;Timepoint(s) of evaluation of this end point: At end of study (2016-2017) | — |
Countries
Austria, Sweden
Contacts
Public ContactSponsor's representative
Medizinische Universität Innsbruck, Universitätsklinik für Neurologie
Outcome results
None listed