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

Completed

• Conditions: Relapsing Remitting MS (RRMS); Secondary Progressive MS (SPMS)
• Interventions: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

• Registration Number: NCT01233245
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-14
• Last Update Posted: 2012-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1077

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Interferon beta-1b (Betaseron, BAY86-5046)	-

Primary Outcome Measures

Name	Time	Method
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.	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.	After 2 years

Secondary Outcome Measures

Name	Time	Method
Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence.	After 2 years
Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS.	After 2 years
Assessment of coping processes by applying the Ways of Coping Questionnaire.	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.	After 2 years