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

Bayer1,077 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,077

Conditions

Relapsing Remitting MS (RRMS)Secondary Progressive MS (SPMS)

Interventions

Interferon beta-1b (Betaseron, BAY86-5046)DRUG

250 µg, sub-cutaneously, on alternate days

Eligibility

Medical Language ↔ Plain English

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

Locations (15)

Unnamed facility

Many Locations, Czechia

Unnamed facility

Many Locations, France

Unnamed facility

Many Locations, Germany

Unnamed facility

Many Locations, Iran

Unnamed facility

Many Locations, Israel

Unnamed facility

Many Locations, Italy

Unnamed facility

Many Locations, Jordan

Unnamed facility

Many Locations, Lebanon

Unnamed facility

Many Locations, Netherlands

Unnamed facility

Many Locations, Portugal

...and 5 more locations

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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

Assessment of coping processes by applying the Ways of Coping Questionnaire.

Time frame: 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