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

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: BAY86-5046_Interferon-beta-1b

• Registration Number: NCT01158183
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-07
• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-07
• Last Update Submitted: 2010-07-07
• Study First Posted: 2010-07-08
• Last Update Posted: 2010-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	BAY86-5046_Interferon-beta-1b	No intervention

Primary Outcome Measures

Name	Time	Method
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