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

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01158183

First received: July 7, 2010

Last updated: NA

Last verified: July 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

July 7, 2010

Last Updated Date

July 7, 2010

Start Date ^ICMJE

July 2007

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

"real world" population

Condition ^ICMJE

Multiple Sclerosis, Relapsing-Remitting

Intervention ^ICMJE

Drug: BAY86-5046_Interferon-beta-1b

Electronic questionnaires

Study Group/Cohort (s)

Group 1

No intervention

Intervention: Drug: BAY86-5046_Interferon-beta-1b

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

226

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01158183

Other Study ID Numbers ^ICMJE

14838, BF0714US, 311644

Has Data Monitoring Committee

Responsible Party

Medical Director, Bayer Healthcare Pharmaceuticals Inc.

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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