Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment

Study Overview
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Brief Summary
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The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression. The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.

Official Title
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Betaferon Prospective Study on Adherence, Coping and Nursing Support

Conditions
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Relapsing Remitting Multiple Sclerosis (RRMS)

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: Patients after first clinical event suggestive of multiple Sclerosis (MS) (according to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis. Exclusion Criteria: Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)

Ages Eligible for Study
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Minimum Age: 12 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 |
| --- | --- |
| Arm 1<br> | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Patients after first clinical events suggestive of MS (according to SMPC) and patients with RRMS within the first two years of diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients adhering to treatment |  | 6, 12, 18 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of early treatment termination |  | 6, 12, 18 and 24 months | 
| Rate of study dropout |  | 6, 12, 18 and 24 months | 
| Predictive value of BL parameters, WCQ, HADS, RODQ |  | 12 and 24 months | 
| WCQ (Ways of Coping Questionnaire) |  | 6, 12, 18 and 24 months | 
| HADS (Hospital Anxiety and Depression Scale) |  | 6, 12, 18 and 24 months | 
| RODQ (Risk of Dropout Questionnaire) |  | Monthly over 6 months; every other month thereafter | 
| EDSS (Expanded Disability Status Scale) |  | 6, 12, 18 and 24 months | 
| Relapse rate |  | 6, 12, 18 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinically Isolated Syndrome (CIS)