Trial Condition(s):
Multiple Sclerosis
Study of Betaferon adherence in patients with multiple sclerosis treated with interferon beta-1b (ADHERENCE)
Bayer Identifier:
2008/01880
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
Inclusion Criteria
- Patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) or patients with a first outbreak or clinically isolated syndrome (CIS) that carry more than 6 months in treatment with interferon beta-1b
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
120
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No
Where to Participate
Locations
| Locations |
|---|
Trial Design
Cross-sectional retrospective study of therapeutic compliance in patients with multiple sclerosis treated with interferon beta-1b
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) testTimeframe: Four weeks just before baseline visit
Secondary Outcome
- Demographic dataAge, sex, marital status, education level, employment statusTimeframe: At baseline
- Number of patients with MS diagnosisTimeframe: At baseline
- Age at first episode and at diagnosisTimeframe: At baseline
- Time since last relapseTimeframe: At baseline
- Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator teamTimeframe: 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.Timeframe: At baseline
- Number of patients with adverse events during the last monthTimeframe: 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.Timeframe: At baseline
- Time on INFb-1b therapyTimeframe: At baseline
Additional Information
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