check_circleStudy Completed
Multiple Sclerosis
Bayer Identifier:
2008/01880
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study of Betaferon adherence in patients with multiple sclerosis treated with interferon beta-1b
Trial purpose
The primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more than 6 months in treatment.
Key Participants Requirements
Sex
AllAge
18 - 100 YearsTrial summary
Enrollment Goal
120Trial Dates
February 2009 - March 2010Phase
N/ACould I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoPrimary Outcome
- Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) testdate_rangeTime Frame:Four weeks just before baseline visit
Secondary Outcome
- Demographic dataAge, sex, marital status, education level, employment statusdate_rangeTime Frame:At baseline
- Number of patients with MS diagnosisdate_rangeTime Frame:At baseline
- Age at first episode and at diagnosisdate_rangeTime Frame:At baseline
- Time since last relapsedate_rangeTime Frame:At baseline
- Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator teamdate_rangeTime Frame:At baseline
- Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MSThe EDSS quantifies the disability in eight functional systems (FS) and allows neurologists to assign a level of Functional System in each of them caused by multiple sclerosis.date_rangeTime Frame:At baseline
- Number of patients with adverse events during the last monthdate_rangeTime Frame:Four weeks just before baseline visit
- Clinical setting characteristics like existence of MS unitThe existence of Multiple Sclerosis Unit was evaluated bearing in mind if the hospital had or had not available a Multiple Sclerosis Unit into the hospital Neurology Department.date_rangeTime Frame:At baseline
- Time on INFb-1b therapydate_rangeTime Frame:At baseline
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A