check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

14323

ClinicalTrials.gov Identifier:

NCT01184833

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of risk factors for early termination of injection treatment with Betaferon in patients suffering from multiple sclerosis

Trial purpose

Non-adherence to the treatment regimen is a common problem associated with injectable drugs (e.g. Betaferon) that are used in multiple sclerosis patients.
Certain patients omit single injections or even totally discontinue therapy that normally should be long-term. It is therefore crucial to identify the factors which have the most significant effect on regularity of administration of Betaferon and the risk of premature discontinuation of treatment in order to undertake appropriate preventive measures.
This study is conducted in routine practice setting and aims to identify those risks. Pre-defined risk factors associated with technical aspects of the treatment, support provided to the patient, stage of the disease and possible adverse effects of the medication are checked on a quarterly basis with a questionnaire method. Monitoring of omitted doses of the prescribed medication (Betaferon) is carried out by the study nurse.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Relapsing-remitting multiple sclerosis
    - Age >/= 18 years
    - Start of treatment with Betaferon not earlier than 60 days prior to inclusion
  • - Synonymous with contraindications to Betaferon

Trial summary

Enrollment Goal
852
Trial Dates
September 2008 - August 2011
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Poland

Primary Outcome

  • Rate of discontinuation of Betaferon
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of missed doses of Betaferon
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • Depression score as measured by CES-D questionnaire
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Neurological disability score as measured by EDSS scale
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • Overall tolerability of treatment as measured by rate of adverse events
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Evaluation of risk factors for premature discontinuation of injection treatment with Betaferon in patients with relapsing forms of multiple sclerosis
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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