PATIENT WITH RRMS AND SPMS MedDRA version: 13.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: BETAFERON*15CONFEZ 0,25MG/ML+
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1b
Concentration unit: µmole/ml micromole(s)/millilitre
Concentration type: e
Sponsors
AZIENDA OSPEDALIERA S. LUIGI GONZAGA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with RRMS confermed with Mc Donald`s criterya or with SPMS - naive for other previous immunomodular or immunmosoppressive 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - PPSM - Contraindications to treatment with IFNß and/or vit. D
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - to verify the possible bio-molecular effects of interferon-beta and d-vitamin association - to identify different expression of genes in PBMCs in patients in therapy with IFNßalone or in association with d-vitamin - to evaluate tollerability and safety oh therapeutic association of IFNß-vit- D;Secondary Objective: - to evaluate and compare the incidence of NABs e BABs in patients in therapy - to evaluate biological activity of of IFNß-vit- D;Primary end point(s): NOT PROVIDED | — |
Countries
Italy
Outcome results
None listed