Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years Period

Study Overview
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Brief Summary
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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

Official Title
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Prospective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus Program

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon beta-1b (Betaseron, BAY86-5046)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Betaferon 250 microgram<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months) |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%) |  | 6 months, 12 months, 24 months | 
| Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months) |  | 6 months, 12 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 | 
| Tolerability of Betaferon injections (rate and number of injections) |  | 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 of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study |  | 24 months | 
| Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24 |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, BetaPlus program, Recurrent/remittent multiple sclerosis patients, Adherence to treatment regimen