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

July 7, 2010 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Many Locations, Alabama, United States
    • California
      • Many Locations, California, United States
    • Colorado
      • Many Locations, Colorado, United States
    • Florida
      • Many Locations, Florida, United States
    • Illinois
      • Many Locations, Illinois, United States
    • Iowa
      • Many Locations, Iowa, United States
    • Kansas
      • Many Locations, Kansas, United States
    • Louisiana
      • Many Locations, Louisiana, United States
    • Maine
      • Many Locations, Maine, United States
    • Massachusetts
      • Many Locations, Massachusetts, United States
    • Michigan
      • Many Locations, Michigan, United States
    • Missouri
      • Many Locations, Missouri, United States
    • Nevada
      • Many Locations, Nevada, United States
    • New Hampshire
      • Many Locations, New Hampshire, United States
    • New Jersey
      • Many Locations, New Jersey, United States
    • New York
      • Many Locations, New York, United States
    • North Carolina
      • Many Locations, North Carolina, United States
    • North Dakota
      • Many Locations, North Dakota, United States
    • Ohio
      • Many Locations, Ohio, United States
    • Oregon
      • Many Locations, Oregon, United States
    • Pennsylvania
      • Many Locations, Pennsylvania, United States
    • Rhode Island
      • Many Locations, Rhode Island, United States
    • Tennessee
      • Many Locations, Tennessee, United States
    • Texas
      • Many Locations, Texas, United States
    • Virginia
      • Many Locations, Virginia, United States
    • Washington
      • Many Locations, Washington, United States
    • Wisconsin
      • Many Locations, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

"real world" population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
No intervention
Drug: BAY86-5046_Interferon-beta-1b
Electronic questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 1 to12 month outcome questionnaires

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (ESTIMATE)

July 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2010

Last Update Submitted That Met QC Criteria

July 7, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14838
  • BF0714US
  • 311644

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis, Relapsing-Remitting

Clinical Trials on BAY86-5046_Interferon-beta-1b

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe