Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis
ROBUST
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
3 other identifiers
observational
226
1 country
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2007
Typical duration for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 7, 2010
CompletedFirst Posted
Study publicly available on registry
July 8, 2010
CompletedJuly 8, 2010
July 1, 2010
2.2 years
July 7, 2010
July 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Group 1
No intervention
Interventions
Eligibility Criteria
"real world" population
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (27)
Unknown Facility
Many Locations, Alabama, United States
Unknown Facility
Many Locations, California, United States
Unknown Facility
Many Locations, Colorado, United States
Unknown Facility
Many Locations, Florida, United States
Unknown Facility
Many Locations, Illinois, United States
Unknown Facility
Many Locations, Iowa, United States
Unknown Facility
Many Locations, Kansas, United States
Unknown Facility
Many Locations, Louisiana, United States
Unknown Facility
Many Locations, Maine, United States
Unknown Facility
Many Locations, Massachusetts, United States
Unknown Facility
Many Locations, Michigan, United States
Unknown Facility
Many Locations, Missouri, United States
Unknown Facility
Many Locations, Nevada, United States
Unknown Facility
Many Locations, New Hampshire, United States
Unknown Facility
Many Locations, New Jersey, United States
Unknown Facility
Many Locations, New York, United States
Unknown Facility
Many Locations, North Carolina, United States
Unknown Facility
Many Locations, North Dakota, United States
Unknown Facility
Many Locations, Ohio, United States
Unknown Facility
Many Locations, Oregon, United States
Unknown Facility
Many Locations, Pennsylvania, United States
Unknown Facility
Many Locations, Rhode Island, United States
Unknown Facility
Many Locations, Tennessee, United States
Unknown Facility
Many Locations, Texas, United States
Unknown Facility
Many Locations, Virginia, United States
Unknown Facility
Many Locations, Washington, United States
Unknown Facility
Many Locations, Wisconsin, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 7, 2010
First Posted
July 8, 2010
Study Start
July 1, 2007
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
July 8, 2010
Record last verified: 2010-07