check_circleStudy Completed

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

Bayer Identifier:

14192

ClinicalTrials.gov Identifier:

NCT01233245

EudraCT Number:

Not Available

EU CT Number:

Not Available
BetaPlus Survey – Observational study to assess drug adherence in patients with multiple sclerosis after conversion to Betaferon® by using elements of the BetaPlus Program

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 - Ways of Coping Questionnaire) 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
1077
Trial Dates
April 2004 - June 2009
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, Germany
Completed
Many Locations, France
Completed
Many Locations, Italy
Completed
Many Locations, Spain
Completed
Many Locations, Netherlands
Completed
Many Locations, Czech Republic
Completed
Many Locations, Israel
Completed
Many Locations, Portugal
Completed
Many Locations, Turkey
Completed
Many Locations, Korea, Republic Of
Completed
Many Locations, Taiwan
Completed
Many Locations, Saudi Arabia
Completed
Many Locations, Iran
Completed
Many Locations, Jordan
Completed
Many Locations, Lebanon

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

BetaPlus Survey – Observational study to assess drug adherence in patients with multiple sclerosis 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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