Relapsing Remitting MS (RRMS) Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 1077 |
| Est. completion date | June 2009 |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
Czech Republic, France, Germany, Iran, Islamic Republic of, Israel, Italy, Jordan, Korea, Republic of, Lebanon, Netherlands, Portugal, Saudi Arabia, Spain, Taiwan, Turkey,
Pozzilli C, Schweikert B, Ecari U, Oentrich W; BetaPlus Study group. Supportive strategies to improve adherence to IFN ß-1b in multiple sclerosis--results of the ßPlus observational cohort study. J Neurol Sci. 2011 Aug 15;307(1-2):120-6. doi: 10.1016/j.jn — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Primary | 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 | No | |
| Secondary | Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence. | After 2 years | No | |
| Secondary | Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS. | After 2 years | No | |
| Secondary | Assessment of coping processes by applying the Ways of Coping Questionnaire. | After 2 years | No | |
| Secondary | 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 | Yes |