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Completed

NCT Number: NCT01233245

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

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.

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Key information

Conditions

Relapsing Remitting MS (RRMS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Secondary Progressive MS (SPMS)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Czechia

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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

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Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Nov 3, 2010
Registry last updated
Nov 15, 2012

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

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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.

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