check_circleStudy Completed

Multiple Sclerosis, Relapsing-Remitting

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

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - 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
  • - 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
July 2007 - September 2009
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    Baseline, 1 to12 month outcome questionnaires
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A