This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: July 7, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
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 Intervention
Multiple Sclerosis, Relapsing-Remitting Drug: BAY86-5046_Interferon-beta-1b

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Enrollment: 226
Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
No intervention
Drug: BAY86-5046_Interferon-beta-1b
Electronic questionnaires


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01158183

  Show 27 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Director, Bayer Healthcare Pharmaceuticals Inc. Identifier: NCT01158183     History of Changes
Other Study ID Numbers: 14838
Study First Received: July 7, 2010
Last Updated: July 7, 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 processed this record on August 23, 2017