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

NCT ID: NCT01158183

Last Updated: 2010-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

No intervention

BAY86-5046_Interferon-beta-1b

Intervention Type DRUG

Electronic questionnaires

Interventions

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BAY86-5046_Interferon-beta-1b

Electronic questionnaires

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Healthcare Pharmaceuticals Inc.

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, Alabama, United States

Site Status

Many Locations, California, United States

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Many Locations, Colorado, United States

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Many Locations, Florida, United States

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Many Locations, Illinois, United States

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Many Locations, Iowa, United States

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Many Locations, Kansas, United States

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Many Locations, Louisiana, United States

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Many Locations, Maine, United States

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Many Locations, Massachusetts, United States

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Many Locations, Michigan, United States

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Many Locations, Missouri, United States

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Many Locations, Nevada, United States

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Many Locations, New Hampshire, United States

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Many Locations, New Jersey, United States

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Many Locations, New York, United States

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Many Locations, North Carolina, United States

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Many Locations, North Dakota, United States

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Many Locations, Ohio, United States

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Many Locations, Oregon, United States

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Many Locations, Pennsylvania, United States

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Many Locations, Rhode Island, United States

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Many Locations, Tennessee, United States

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Many Locations, Texas, United States

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Many Locations, Virginia, United States

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Many Locations, Washington, United States

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Many Locations, Wisconsin, United States

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Countries

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United States

Other Identifiers

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BF0714US

Identifier Type: -

Identifier Source: secondary_id

311644

Identifier Type: -

Identifier Source: secondary_id

14838

Identifier Type: -

Identifier Source: org_study_id

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