check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

2008/01880

ClinicalTrials.gov Identifier:

NCT03408093

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

All

Age

18 - 100 Years
  • - 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

  • -

Trial summary

Enrollment Goal
120
Trial Dates
February 2009 - March 2010
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Primary Outcome

  • Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test
    date_rangeTime Frame:
    Four weeks just before baseline visit

Secondary Outcome

  • Demographic data
    Age, sex, marital status, education level, employment status
    date_rangeTime Frame:
    At baseline
  • Number of patients with MS diagnosis
    date_rangeTime Frame:
    At baseline
  • Age at first episode and at diagnosis
    date_rangeTime Frame:
    At baseline
  • Time since last relapse
    date_rangeTime Frame:
    At baseline
  • Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team
    date_rangeTime Frame:
    At baseline
  • Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MS
    The 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 month
    date_rangeTime Frame:
    Four weeks just before baseline visit
  • Clinical setting characteristics like existence of MS unit
    The 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 therapy
    date_rangeTime Frame:
    At baseline

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
N/A

Additional Information

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