check_circleStudy Completed

Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS)

Bayer Identifier:

14235

ClinicalTrials.gov Identifier:

NCT01235455

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

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

Trial summary

Enrollment Goal
10
Trial Dates
August 2007 - May 2011
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Portugal

Primary Outcome

  • 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.
    date_rangeTime Frame:
    After 2 years
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    After 2 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence.
    date_rangeTime Frame:
    After 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS.
    date_rangeTime Frame:
    After 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of coping processes by applying the Ways of Coping Questionnaire.
    date_rangeTime Frame:
    After 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Measurement of safety of Betaferon by assessing the number of participants with adverse events and severe adverse events. Classification by MedDRA category.
    date_rangeTime Frame:
    After 2 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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