Relapsing Remitting MS (RRMS), Secondary Progressive MS (SPMS)
Conditions
Keywords
Multiple Sclerosis, Adherence, Interferon beta-1b, Coping Styles
Brief summary
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.
Interventions
250 µg, sub-cutaneously, on alternate days
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | After 2 years |
| 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. | After 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence. | After 2 years |
| Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS. | After 2 years |
| Assessment of coping processes by applying the Ways of Coping Questionnaire. | 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. | After 2 years |
Countries
Czechia, France, Germany, Iran, Israel, Italy, Jordan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Korea, Spain, Taiwan, Turkey (Türkiye)
Outcome results
None listed