Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, BetaPlus program, Recurrent/remittent multiple sclerosis patients, Adherence to treatment regimen
Brief summary
The aim of the SEPLUS study is to evaluate the patients characteristics associated with adherence to Betaferon over a 24-month follow up period after the initiation of Betaferon in the BetaPlus program
Interventions
Betaferon 250 microgram
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female \>/= 18 years old * Outpatient with a confirmed diagnosis of Recurrent-Remittent multiple sclerosis or patients at high risk of developing multiple sclerosis after a first demyelinating clinical event * Patient who initiated Betaferon as described by SmPC less than 2 months ago. The decision of physician is clearly separated from the decision to include the patient in the study * Treatment naïve patients before the initiation of Betaferon * OR Patients having interrupted Betaferon for more than 6 months before to start again * OR Patients receiving a disease modifying drug (DMD) other than Betaferon * Patient with EDSS score \< 4 * Patients approved and signed an inform consent and approved the collect of their data
Exclusion criteria
* Contraindications and warning of the respective Summary of Product Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months) | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months) | 6 months, 12 months |
| Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study | 24 months |
| Rate of patients with prematurely study discontinuation | 0-6 months, 6-12 months, 12-18 months, 18-24 months |
| Patient's autonomy with regard to the Betaferon® injections (Number of injections realized by the patient alone/total number of injections) | 24 months |
| Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%) | 6 months, 12 months, 24 months |
| Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis]) | 24 months |
| Fatigue (mean total score of FSS [Fatigue Severity scale]) | 24 months |
| Progression of clinical Condition( annual rate of Relapses) | 24 months |
| Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24 | 24 months |
| Tolerability of Betaferon injections (rate and number of injections) | 24 months |
Countries
France
Outcome results
None listed