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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01158183
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : July 8, 2010
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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.

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing-Remitting Drug: BAY86-5046_Interferon-beta-1b

Study Type : Observational
Actual Enrollment : 226 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : July 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1
No intervention
Drug: BAY86-5046_Interferon-beta-1b
Electronic questionnaires

Primary Outcome Measures :
  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 [ Time Frame: Baseline, 1 to12 month outcome questionnaires ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
"real world" population

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01158183

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Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Medical Director, Bayer Healthcare Pharmaceuticals Inc. Identifier: NCT01158183     History of Changes
Other Study ID Numbers: 14838
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: July 8, 2010
Last Verified: July 2010

Keywords provided by Bayer:
real world and web tool
electronic data capture

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic