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

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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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 
Locations

Investigative Site

Many Locations, United States

Status
Completed
 

Trial Design