Trial Condition(s):

Multiple Sclerosis, Relapsing-Remitting

Real-World Betaseron Health Economic Outcomes Study for relapsing forms of multiple sclerosis (ROBUST)

Bayer Identifier:

14838

ClinicalTrials.gov Identifier:

NCT01158183

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
226
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Investigative Site

Many Locations, United States

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Many Locations, United States

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Many Locations, United States

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Many Locations, United States

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Many Locations, United States

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Many Locations, United States

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Many Locations, United States

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Many Locations, United States

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Many Locations, United States

Trial Design