Skip to main content
OpenTrials
Completed

NCT Number: NCT01235455

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Relapsing Remitting Multiple Sclerosis (RRMS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Secondary Progressive Multiple Sclerosis (SPMS)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

250 µg, sub-cutaneously, on alternate days

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

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

    Time frame: After 2 years

  4. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: POR-BetaPlus

Important dates

Study start
2007
Study completion
2011
First posted
Nov 5, 2010
Registry last updated
Nov 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.