BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program

November 14, 2012 updated by: Bayer
This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1077

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients, who were recruited at neurologic practices or specialized neurological centers, were eligible for selection if they had relapsing-remitting MS (RRMS) or secondary-progressive MS (SPMS)

Description

Inclusion Criteria:

  • Relapsing-remitting MS (RRMS) or secondary-progressive MS (SPMS)
  • Previous treatment with disease modifying drugs
  • Adjustment of disease modifying treatment necessary at the discretion of the investigator
  • Switch to Betaferon at least 1 month but not longer than 3 months prior to inclusion

Exclusion Criteria:

  • Patients not fulfilling the indications in the local prescribing information
  • Refusal to sign inform consent

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
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
250 µg, sub-cutaneously, on alternate days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of reasons why patients are switched from other disease modifying drugs to Betaferon due to perceived lack of efficacy, adverse events, poor compliance, and others.
Time Frame: After 2 years
After 2 years
Assessment of factors predictive of non-adherence to disease modifying drugs such as demographic data, course of disease, drug history, patients characteristics, history of poor compliance to prior therapy or others.
Time Frame: After 2 years
After 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence.
Time Frame: After 2 years
After 2 years
Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS.
Time Frame: After 2 years
After 2 years
Assessment of coping processes by applying the Ways of Coping Questionnaire.
Time Frame: After 2 years
After 2 years
Measurement of safety of Betaferon by assessing the number of participants with adverse events and severe adverse events. Classification by MedDRA category.
Time Frame: After 2 years
After 2 years

Collaborators and Investigators

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

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2004

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimate)

November 3, 2010

Study Record Updates

Last Update Posted (Estimate)

November 15, 2012

Last Update Submitted That Met QC Criteria

November 14, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14192
  • BF0704 (Other Identifier: Company Internal)

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.

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Conditions

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Locations

3
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