Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectors

Relapsing Remitting Multiple Sclerosis (RRMS) Clinical Trial

— POR-BetaPlus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235455
• Other study ID #: 14235
• Secondary ID: BF0710PT
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: October 30, 2012
• Start date: August 2007
• Est. completion date: May 2011

Study information

• Verified date: October 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: National Pharmacy and Medicines Institute
• Study type: Observational

Clinical Trial 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) and depression questionnaire CES-D.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis (RRMS)
• Sclerosis
• Secondary Progressive Multiple Sclerosis (SPMS)

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence.		After 2 years	No
Secondary	Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS.		After 2 years	No
Secondary	Assessment of coping processes by applying the Ways of Coping Questionnaire.		After 2 years	No
Secondary	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	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.