Remitting relapsing multiple sclerosis (RRMS) is one of the most common diseases of the central nervous system. The cause of MS is not yet known but it is a result of damage to myelin. Symptoms vary widely and include blurred vision, weak limbs, tingling sensations, unsteadiness and fatigue.
Conditions
Interventions
Trade Name: Betaferon
Product Name: Betaferon
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Beta-1b interferoni
Concentration unit: µg/ml microgram(s)/millili
Sponsors
Schering Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group A : RRMS patients (male and female) who have been using Betaferon at least five years and are still using it. Group B: RRMS patients (male and female) who have been using Betaferon and who have discontinued it. Signed Informed Consent. 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: Group A: RRMS patients who have been using Betaferon less than five years. Group B: the current use of Betaferon.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Group A still continue Betaferon treatment. Group B have discontinued the Betaferon treatment. Group A: to assess the clinical state of MS-patients after at least 5 years use of Betaferon by using EDSS. Group B: to assess the reason for Betaferon discontinuation.;Secondary Objective: Group A: to compare MRI results in the beginning of the Betaferon treatment and results of MRI taken in connection with the study visit. And to investigate the number of patients who have developed neutralizing antibodies againts Betaferon treatment. ;Primary end point(s): | — |
Countries
Finland
Outcome results
None listed