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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— ROBUST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158183
• Other study ID #: 14838
• Secondary ID: BF0714US311644
• Status: Completed
• Phase: N/A
• First received: July 7, 2010
• Last updated: July 7, 2010
• Start date: July 2007
• Est. completion date: September 2009

Study information

• Verified date: July 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• BAY86-5046_Interferon-beta-1b
Electronic questionnaires

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

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