Trial Condition(s):
Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS)
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 (POR-BetaPlus)
Bayer Identifier:
14235
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Portugal | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
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.Timeframe: After 2 years
- 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.Timeframe: After 2 years
Secondary Outcome
- Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence.Timeframe: After 2 years
- Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS.Timeframe: After 2 years
- Assessment of coping processes by applying the Ways of Coping Questionnaire.Timeframe: After 2 years
- Measurement of safety of Betaferon by assessing the number of participants with adverse events and severe adverse events. Classification by MedDRA category.Timeframe: After 2 years
Additional Information
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