check_circleStudy Completed

Relapsing-Remitting Multiple Sclerosis

Bayer Identifier:

14543

ClinicalTrials.gov Identifier:

NCT00902135

EudraCT Number:

Not Available

EU CT Number:

Not Available
Injection management with Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)

Trial purpose

Aim of the BETAPATH study is to evaluate whether the use of a personal digital assistant (PDA) can improve the adherence of Multiple Sclerosis patients to a therapy with Betaseron. The Personal digital assistant PDA functions as an electronic diary and as an injection reminder.

Key Participants Requirements

Sex

Both

Age

18 - N/A


  • - Outpatients with the diagnosis of Multiple Sclerosis and decision by the investigator to prescribe Betaferon.The decision for treatment type and duration is taken before offering the patient the possibility to participate in the study.


  • - Patients, who do not meet the Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS) criteria, should not be included.
    - Exclusion criteria must be read in conjunction with the German product information.

Trial summary

Enrollment Goal
702
Trial Dates
May 2009 - August 2014
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, Germany

Primary Outcome

  • Drop out rate over 2 years
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Disability status
    date_rangeTime Frame:
    After 3, 6, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Grade of depressiveness
    date_rangeTime Frame:
    After 3, 6, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Grade of fatigue
    date_rangeTime Frame:
    After 3, 6, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Quality of life
    date_rangeTime Frame:
    After 3, 6, 12 and 24 months
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    Safety Issue:
    No
  • Cognitive status
    date_rangeTime Frame:
    After 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Injection regularity
    date_rangeTime Frame:
    After 3, 6, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Betaferon® injection management: Non-interventional study on personal digital assistant (PDA)supported effects on Adherence to a long-term injection Therapy (BETAPATH)
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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