Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis

Study Overview
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Brief Summary
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A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS) population capturing outcomes reported by patients and by the physicians during 12 months after initiating or resuming Betaseron.

Official Title
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Real-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon β-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: BAY86-5046_Interferon-beta-1b


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provides written informed consent to participate in the study At least 18 but no more than 65 years old Documented clinical diagnosis of a relapsing form of multiple sclerosis or confirmed clinically isolated syndrome (CIS) Initiating Betaseron therapy, or resuming Betaseron after not having used it for at least three months Willing and able to provide a valid e-mail address which will be in use for the duration of the study Willing and able to complete study questionnaires via the Internet Has reliable Internet access for the duration of the study Completes the baseline patient questionnaire Exclusion Criteria: Kurtzke Expanded Disability Status Scale (EDSS) score greater than 6.0 Cognitive dysfunction that, in the Investigator's judgment, raises doubts about the study participant's ability to provide informed consent or accurately complete the monthly patient questionnaire Any use of Betaseron within the three months prior to study entry Inability to read, write, or speak the English language Illness or disease other than multiple sclerosis that the Investigator believes is likely to cause the patient's death or incapacity within twelve months Any severe, uncontrolled illness or condition that the Investigator believes could dominate the patient's quality of life Coexistent autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis that is likely to be exacerbated by treatment with Interferon Current use of any immunosuppressive medication Previous participation in a multiple sclerosis (MS) clinical trial within the three months prior to study entry Previous use of monoclonal antibodies treating MS within the three months prior to study entry Current use of any secondary treatment for multiple sclerosis other than the episodic use of steroids during relapses or exacerbations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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>No intervention | Drug: BAY86-5046_Interferon-beta-1b<br>* Electronic questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Key Objective: To collect patient reported outcomes and clinical assessments via the same web-based data capture tool in a real world setting in relapse-remitting multiple sclerosis patients |  | Baseline, 1 to12 month outcome questionnaires | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outcomes, real world and web tool, electronic data capture