Clinical trial NCT01233245: BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting MS (RRMS)
Secondary Progressive MS (SPMS)
Keywords: Multiple Sclerosis
Adherence
Interferon beta-1b
Coping Styles
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 1077
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, who were recruited at neurologic practices or specialized neurological centers, were eligible for selection if they had relapsing-remitting MS (RRMS) or secondary-progressive MS (SPMS)

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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 outcomes:
measure: Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence.
timeFrame: After 2 years
measure: 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
measure: Assessment of coping processes by applying the Ways of Coping Questionnaire.
timeFrame: After 2 years
measure: 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
Other outcomes:
Locations:
city: Many Locations
country: Czech Republic
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Iran, Islamic Republic of
city: Many Locations
country: Israel
city: Many Locations
country: Italy
city: Many Locations
country: Jordan
city: Many Locations
country: Korea, Republic of
city: Many Locations
country: Lebanon
city: Many Locations
country: Netherlands
city: Many Locations
country: Portugal
city: Many Locations
country: Saudi Arabia
city: Many Locations
country: Spain
city: Many Locations
country: Taiwan
city: Many Locations
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Pozzilli C, Schweikert B, Ecari U, Oentrich W; BetaPlus Study group. Supportive strategies to improve adherence to IFN beta-1b in multiple sclerosis--results of the betaPlus observational cohort study. J Neurol Sci. 2011 Aug 15;307(1-2):120-6. doi: 10.1016/j.jns.2011.04.026. Epub 2011 Jun 1.